816ViSure transport kit19Trivitron Healthcare Pvt. LtdIndiawww.trivitron.com/YesCommercialisedNoNoOtherOtherVIsure (Viral transport media): VIsure features all required modalities that can be used for COVID-19 specimen collection kit. VIsure (Viral transport media)2021-05-10 13:04:00656OtherOtherTransport kit939Total RNA Purification Kit Dx (Dx17200)189Norgen Biotek Corp.Canadanorgenbiotek.com/YesCommercialisedNoNoOtherOther2021-05-10 13:04:00742OtherOtherExtraction kit https://norgenbiotek.com/sites/default/files/flyers/Coronavirus%20Flyer%20v1-min.pdfType of antigenSARS-CoV2 recombinant antigen415Tongue swab diagnosis of SARS-CoV-2267University of WashingtonUnited Stateswww.deohs.washington.eduNoIn developmentNoNoOtherOther2021-05-10 13:04:00337OtherOtherSample collection device752SARS-CoV-2 Clinical Sequencing assay456Vision MedicalsChinawww.visionmedicals.com/YesCommercialisedNoNoOtherOther2021-05-10 13:04:00624OtherOtherOther http://www.visionmedicals.com/312Pinpoint Covid-19 Screening Assay – Electrical detection of SARS-CoV-2 nucleocapsid protein using nanosensors and aptamer200Pinpoint Science IncUnited Statespinpointscience.com/NoIn developmentNoNoNear POC / POCOther2021-05-10 13:04:00257OtherYesOtherRapid diagnostic test 309PEPperCHIP SARS-CoV-2 Proteome Microarray (manual)198PEPperPRINT GmbHGermanywww.pepperprint.com/YesCommercialisedNoNoAutomatedManualOther2021-05-10 13:04:00255OtherN.A.OtherN.A.Manual or automated Type of antigencolloidal gold labelled covid antigen656Palladium387Integrated Nano-TechnologiesUnited Stateswww.intpalladium.comNoIn developmentNoNoLab-basedOther2021-05-10 13:04:00535OtherOther412NGS-based target capture for SARS-CoV-2 detection and screening264Twist BioscienceUnited Stateswww.twistbioscience.com/NoIn developmentNoNoOtherOther2021-05-10 13:04:00334OtherSequencingOther373LyoDx A Freeze-Dried Real-Time RT-PCR Detection Reagent for SARS-CoV-2244SignalDT Biotechnologies (SZ), IncChinawww.signaldtbio.cn/NoIn developmentNoNoManualOther Information provided by manufacturer 2021-05-10 13:04:00307OtherRT-PCRType of antigenSARS-CoV-2 Spike S1-RBD protein65InferRead CT Pneumonia40Beijing Infervision Technology Co. LtdChinaglobal.infervision.com/NoIn developmentNoNoOtherOther2021-05-10 13:04:0047OtherOtherVisualisation system545Edinburgh Genetics Virus Swab Sampling Kit88Edinburgh Genetics LimitedUnited Kingdomeggenetics.com/NoCommercialisedNoNoOtherOther2021-05-10 13:04:00461OtherOtherSample collection device1056Coronavirus Breath Analyzer788TeraBioSafety Ltd Switzerlandwww.tera.groupYesCommercialisedNoNoNear POC / POCOther2021-05-10 13:04:00834OtherYesOtherOther817Collection tools and blood separation for serology diagnostics for SARS-CoV-2474CanaryQUnited Statescanaryq.com/NoCommercialisedNoNoOtherOther2021-05-10 13:04:00657OtherOtherSample collection device 924BHD SEDIPREP COVID-19349Fjord Diagnostics SDNMalaysiawww.fjorddiagnostics.com/YesCommercialisedNoNoManualOther sample preparation for pre-concentration of COVID-19 viral load prior to test analyses; http://www.fjorddiagnostics.com/images/product/Sediprep%20Covid-19.pdf2021-05-10 13:04:00727OtherOtherSample preparationManual NAT 812Bartels FlexTrans Medium473Trinity BiotechIrelandwww.trinitybiotech.comNoCommercialisedNoNoOtherOther2021-05-10 13:04:00654OtherOtherPhosphor technologyOther 42Ativa Enhanced Screen25Ativa MedicalUnited Statesativamed.com/NoIn developmentNoNoManualOther2021-05-10 13:04:0030OtherOther112AiroStotleCV19 (Breath VOCs)888Canary Health TechnologiesUnited Stateswww.canaryhealth.comNoIn developmentNoNoOtherOther2021-05-10 13:04:0078OtherOther649AB Blood plasma separation using ultrasound386AcouSortSwedenacousort.com/NoCommercialisedNoNoOtherOther2021-05-10 13:04:00534OtherOtherSample preparation636YouSeq SARS-COV-2 qPCR Test380YouSeq LtdUnited Kingdomyouseq.com/NoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00525Nucleic acid-PCRRT-PCR922Xpert Xpress SARS-CoV-2506CepheidUnited Stateswww.cepheid.com/YesCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00726Nucleic acid-PCRNoRT-PCR45 https://cepheid.widen.net/s/nb0a4ysmkfPositive controlPositive control not specifiedNegative controlnegative control not specifiedAnalytical Sensitivity100%Analitical Specificity100%205Wondfo SARS-CoV-2 Nucleic Acid Detection Kit124Guangzhou Wondfo Biotech Co., LtdChinaen.wondfo.com.cn/NoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00162Nucleic acid-PCRRT-PCR954WizDx COVID-9 Real-time PCR Kit496Wizbio SolutionsSouth Koreawww.wizbiosolution.comYesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00751Nucleic acid-PCRRT-PCR90 https://b34516c8-fef7-4fb9-8285-73f5f0d49c30.usrfiles.com/ugd/b34516_e08887f0b6014b4f86b0b9e0b3e0e306.pdfLOD15.3copies/rxnRdRP geneLOD14.4copies/rxnE geneNegative controlnuclease-free waterAnalitical Specificity100%Type of antigennucleoprotein953WizDx COVID-9 CrystalMix PCR Kit496Wizbio SolutionsSouth Koreawww.wizbiosolution.comYesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00750Nucleic acid-PCR60 https://www.wizbiosolution.com/product-page/wizdx-covid-19-crystalmix-pcr-kitLOD23.4copies/rxnRdRP gen2LOD19.7copies/rxnE geneNegative controlnuclease-free waterAnalitical Specificity100%Type of antigennucleoprotein894WizDx Covid-19 Crytsal Mix PCR Kit496Wizbio SolutionsSouth Koreawww.wizbiosolution.comNoCommercialisedNoNoAutomatedManualNucleic acid2021-05-10 13:04:00706Nucleic acid-PCRRT-PCR https://www.wizbiosolution.com/single-post/2020/03/09/WizDx%E2%84%A2-COVID-19-CrystalMix-PCR-kit81Wantai SARS-CoV-2 RT-PCR Kit49Beijing Wantai Biological Pharmacy Enterprise Co., LtdChinawww.ystwt.cn/NoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:0056Nucleic acid-PCRRT-PCRManual NAT 427Vitassay qPCR SARS-CoV-2272VitassaySpainvitassay.com/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00346Nucleic acid-PCRRT-PCR https://vitassay.com/now-available-sars-cov-2-i-ii/LOD10copies/reactionPositive controllyophilized SARS-CoV-2 Positive ControlCrossreactivitytested negative with 42 species of micoorganisms141VitaPCR COVID-19 assay76Credo Diagnostics BiomedicalSingaporewww.credodxbiomed.com/YesCommercialisedNoNoLab-basedNucleic acid virus nucleocapsid (N) gene.2021-05-10 13:04:0096Nucleic acid-PCRRT-PCR20 https://www.menarinidiagnostics.it/en-us/Home/Laboratory-Products/COVID-19/VitaPCRTM-platform/Learn-MoreThroughputone sample well492VISION COVID19 Easyprep Test Kit313Turkeywww.visionbiotechnology.com/NoIn developmentNoNoLab-basedNucleic acidSalivaWhole blood2021-05-10 13:04:00413Nucleic acid-PCRRT-PCRType of antigennucleoprotein532virusproof SL SARS-CoV-2 Real-time PCR Kit325BIOTECON Diagnostics GmbHGermanywww.bc-diagnostics.com/NoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00435Nucleic acid-PCRRT-PCRType of antigenCOVID-19 recombinant antigen788459IngenetixAustriawww.ingenetix.com/en/home/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00633Nucleic acid-PCRRT-PCR https://www.ingenetix.com/en/product/human/SARS-CoV-2+%26+SARS/LOD13copies/reactionPositive controlPostive control not specifiedNegative controlnegative control not specifiedClinical Specificity100%tested on 15 samples751ViroKey SARS-CoV-2 RT-PCR Test447Vela DiagnosticsSingaporewww.veladx.com/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00607Nucleic acid-PCRRT-PCR210 https://marketing.veladx.com/acton/media/31800/sars-cov-2-rt-pcr-testLOD50copies/reactionPositive controlORF1a and RdRpCrossreactivityNo cross-reactivity with 18 bacteria and virus species testedClinical Sensitivity100%(95%CI: 88.6%-100%)Clinical Specificity100%(95%CI: 88.6%-100%)Throughput48samplesType of antigennucleoprotein703Viro-Q SARS-CoV-2 kit395BAG DiagnosticsGermanywww.bag-diagnostics.com/de/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00543Nucleic acid-PCRRT-PCR90Positive controlmix of human RNA and SARS-CoV-2 reference RNA123VIASURE SARS-CoV-2 S gene Real Time PCR Detection Kit for BD MAX System737CerTest BiotecSpainwww.certest.esYesCommercialisedNoNoManualNucleic acid2021-05-10 13:18:2086Nucleic acid-PCRRT-PCR https://www.certest.es/wp-content/uploads/2020/03/IU-NCO212enes1120-rev.02.pdfLOD24copies/rxnPositive controlyesNegative controlyesType of antigenORF1ab gene and N gene 122VIASURE SARS-CoV-2 Real Time PCR Detection Kit737CerTest BiotecSpainwww.certest.esYesCommercialisedNoNoManualNucleic acid2021-05-10 13:18:2085Nucleic acid-PCRRT-PCR https://www.certest.es/wp-content/uploads/2020/03/VS-NCO124enes0320-rev-01.pdfType of antigenSpike (S) antigen1643VIASURE SARS-CoV-2 (N1+N2) Real Time PCR Detection Kit for BD MAX System737CerTest BiotecSpainwww.certest.esYesCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:001323Nucleic acid-PCRRT-PCR1642VIASURE SARS-CoV-2 (N1+N2) Real Time PCR Detection Kit737CerTest BiotecSpainwww.certest.esYesCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:001322Nucleic acid-PCRRT-PCR https://www.certest.es/wp-content/uploads/2020/12/IU-NCO312enes1220-rev.01.pdf280VERI-Q PCR 316 COVID-19 detection system174MiCo Biomed Co. LtdSouth Koreawww.micobiomed.com/NoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00230Nucleic acid-PCRRT-PCR419VereCoV OneMix Detection Kit for VerePLEX Biosystem270Veredus Laboratories Pte LtdSingaporewww.vereduslabs.com/YesCommercialisedNoNoLab-basedNucleic acidThe test integrates PCR amplification and microarray for rapid qualitative detection of 2019-nCoV IFU will be provided upon request 2021-05-10 13:04:00342Nucleic acid-PCRRT-PCR120 https://vereduslabs.com/wordpress/wp-content/uploads/2020/03/VereCoV-Press-Release_30-Mar_CE-IVD.pdfLOD10copies/μlPositive controlN1 Positive ControlCrossreactivitydetects SARS-CoV. Without cross-reactivity with other coronaviruses such as OC43, 229E, KhU1, NL63Throughputlab-on-chip956vDetect COVID-19 RT-qPCR diagnostic kit515Eset LtdUnited Kingdomwww.eset.comYesCommercialisedNoNoAutomatedManualNucleic acidData provided by Manufacturer 2021-05-10 13:04:00752Nucleic acid-PCRRT-PCR180 https://www.eset.comLOD8cpr(1.6 cpu)Positive controlfull genomic RNA od coronavirus SARS Cov2Negative controlpcr waterAnalytical Sensitivity100%Analitical Specificity100%Clinical Sensitivity100%Clinical Specificity100%Throughput96 samples per run1077vDetect COVID-19 RT-qPCR diagnostic kit580MultiplexDXUnited Stateswww.multiplexdx.com/YesCommercialisedNoNoAutomatedManualNucleic acidqualitative assay; targeting the E gene, SARS-CoV-2 specific RdRP gene, and human RNase P https://www.multiplexdx.com/product/vdetect-covid-19-rt-qpcr-diagnostic-kit; 2021-05-10 13:04:00855Nucleic acid-PCRRT-PCRN.A.90 https://uploads-ssl.webflow.com/58bcee1de9c6693a0278d729/5f105a60f24778ff0fb3e223_07-2020_MultiplexDX_A4_User%20Information.pdf; One package of the kit is sufficient for 400 testing reactions. Testing flexibility: either single gene screening or precision dual gene diagnostics. E or RdRP gene (based on the end-user preference) can be exclusively used for 400 screening tests. This option is recommended when manysymptomatic patients have to be screened at once. The precision dual gene option is based on running 200 screening assays first (E or RdRP gene) followed by 200 confirmation assays to confirm positive screening results (E or RdRP gene) or eliminate false-positive results. In addition, conducting an internal control assay for human RNase P assesses appropriate swab and RNA extraction, the presence of human RNA within the extracted sample, while eliminating false-negative results. Thus, for the precision dual gene diagnostics workflow, two testing reactions(screening and confirmation) should be performed per one patient and this option is recommended when precision testing is essential.LOD2copies/reactionLOD0.4copies/μlPositive controlfull genomic RNA of coronavirus SARS-COV-2 + human RNA Negative controlnuclease-free water (PCR waterAnalytical Sensitivity100%Analitical Specificity100%Clinical Sensitivity100%Clinical Specificity100%Throughput96samples/run96 samples per run472Upper Respiratory Virus Panel, multiplex PCR, COVID-19, Influenza A B293DNA Software, IncUnited Stateswww.dnasoftware.com/NoIn developmentNoNoManualNucleic acid2021-05-10 13:04:00381Nucleic acid-PCRRT-PCR117UltrFast RT-qLAMP COVID19 Detection kit65CellSafeSouth Koreawww.cells-safe.com/NoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:0081Nucleic acid-PCRLAMP647Ultrasensitive, rapid, and portable coronavirus SARS-CoV-2 sequence detection64Caspr BiotechUnited Statescaspr.bio/NoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00533Nucleic acid-OtherOtherOther764UltraGene Combo2Screen SARS-CoV-2 Assay453Advanced Biological Laboratories SALuxembourgwww.ablsa.com/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00620Nucleic acid-PCRNoRT-PCR105LOD0.000001TCID50/mlAnalitical Specificity100%Clinical Sensitivity100%Clinical Specificity100%347U-TOP COVID-19 Detection Kit227SEASUN BIOMATERIALSSouth Koreawww.seasunbio.com/english/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00290Nucleic acid-PCRRT-PCR http://www.seasunbio.com/english/images/pdf/IFU_COVID-19%20(SS-9011)_V2.0.pdfLOD100000AUPositive controlyesNegative controlyesThroughput94AU413Two single-step quantitative RT reverse transcription PCR assays for N gene and ORF1b of sarbecovirus subgenus265University of Hong KongHong Kong S.A.Rwww.hku.hk/NoUnknownNoNoLab-basedNucleic acidShipped to WHO +30 labs globally2021-05-10 13:04:00335Nucleic acid-PCRRT-PCR3TRUPCR SARS-CoV-2 RT qPCR Kit33B BlackBio Biotech India LtdIndiawww.3bblackbio.com/NoCommercialisedNoNoManualNucleic acidE, RdRP and N gene targets 2021-05-10 13:04:004Nucleic acid-PCRNoRT-PCRhttps://3bblackbio.com/covid-19-corona-virus-real-time-qpcr-kit-sars-cov-2-trupcr.html286Truenat SARS CoV-2 (lab-based or near-POC)179Molbio Diagnostics Pvt LtdIndiawww.molbiodiagnostics.com/NoCommercialisedNoNoLab-basedNear POC / POCNucleic acid2021-05-10 13:04:00236Nucleic acid-PCRRT-PCR1175Total Nucleic Acid Preservation Tubes Dx (Cat#Dx69200)189Norgen Biotek Corp.Canadanorgenbiotek.com/YesCommercialisedNoNoOtherNucleic acid2021-05-10 13:04:00956OtherOtherSample collection deviceNorgen’s Total Nucleic Acid Preservation Tubes Dx are designed for ambient preservation and transport of total nucleic acids (DNA and RNA) from samples collected using a swab. The Total Nucleic Acid Preservation Tubes contain Norgen’s Total Nucleic Acid Preservative in a liquid format. The user simply collects the specimen using a sterile nylon flocked swab (not provided), and then transfers the swab into the Total Nucleic Acid Preservative. The Preservative prevents the growth of Gram-negative and Gram-positive bacteria and fungi, and also inactivates viruses allowing the resulting non-infectious samples to be handled and shipped safely. In addition, the Total Nucleic Acid Preservative eliminates the need to immediately process or freeze samples and allows the samples to be shipped to centralized testing facilities at ambient temperatures. The components of the preservative allow DNA samples to be stored at room temperature for over 4 months and RNA samples to be stored at room temperature for over 2 months. This kit is ideal for collecting and preserving nasal and oral swab samples for in vitro diagnostic use for medical purposes926The Novel Coronavirus (2019-nCoV) Nucleic Acid Test Kit101GeneFirst LtdUnited Kingdomwww.genefirst.com/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00729Nucleic acid-PCRRT-PCR100Positive controlPositive control not specifiedNegative controlnegative control not specifiedThroughputSingle tubes211The golden standard of SARS-CoV-2 viral nucleic acid detection127Hangzhou Bigfish Bio-tech Co., LtdChinawww.bigfishgene.com/NoIn developmentNoNoManualNucleic acid2021-05-10 13:04:00167Nucleic acid-PCRRT-PCR394Test detection Coronavirus (COVID-19)254SYN LABItalywww.synlab.it/NoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00317Nucleic acid-PCRRT-PCRType of antigenNucleocapsid and Spike protein403TaqPath COVID-19 Combo Kit260Thermo Fisher ScientificUnited Stateswww.thermofisher.com/ch/en/home.htmlNoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00325Nucleic acid-PCRRT-PCR875TaqPath COVID-19 CE-IVD RT-PCR Kit260Thermo Fisher ScientificUnited Stateswww.thermofisher.com/ch/en/home.htmlYesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00692Nucleic acid-PCRRT-PCRSample preparation120 https://www.thermofisher.com/order/catalog/product/A48067?SID=srch-hj-A48067#/A48067?SID=srch-hj-A48067LOD10GCE/reactionPositive controlPositive control not specifiedAnalytical Sensitivity100%Analitical Specificity100%Throughput382samples402TaqMan SARS-CoV-2 Assay Kit v2260Thermo Fisher ScientificUnited Stateswww.thermofisher.com/ch/en/home.htmlNoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00324Nucleic acid-PCRRT-PCR203Supbio SARS-CoV-2 (ORF1ab/N) (Nucleic Acid Detection Kit / PCR-Fluorescent)122Guangzhou Supbio Biotechnologies, IncChinawww.supbio.com/NoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00160Nucleic acid-PCRRT-PCR1224StrongStep Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit (detection for three genes)417Nanjing Liming BioProducts Co., LtdChinawww.limingbio.comYesCommercialisedNoNoLab-basedNucleic acid https://www.limingbio.com/sars-cov-2-rt-pcr-product/2021-05-10 13:04:001008Nucleic acid-PCRNoRT-PCR100LOD3.9cpuPositive controlThe Positive Control should produce Cq value ?35 in FAM/HEX/ROX channelNegative controlNEC or No template control is free from amplification in the all channelsAnalytical Sensitivity99.6%Analitical Specificity100%Clinical Sensitivity99.6%Clinical Specificity100%Throughput96samples/run759STOPCovid kit451Broad InstituteUnited Stateswww.broadinstitute.orgNoIn developmentNoNoLab-basedNucleic acid2021-05-10 13:04:00616Nucleic acid-OtherOtherOther https://www.broadinstitute.org/files/publications/special/COVID-19%20detection%20(updated).pdf353STAT-NAT Covid-19 HK233Sentinel CHItalywww.sentineldiagnostics.com/YesCommercialisedNoNoManualNucleic acidBased on WHO-5 and WHO-3 2021-05-10 13:04:00296Nucleic acid-PCRRT-PCR120 https://www.sentineldiagnostics.com/molecular-biology/stat-nat-covid-19/Positive controlEvaluatedNegative controlEvaluated1436STAT-NAT Covid-19 B233Sentinel CHItalywww.sentineldiagnostics.com/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:001188Nucleic acid-PCRRT-PCR343STANDARD M nCoV Real-Time Detection Kit224SD BIOSENSOR IncSouth Koreahttp://sdbiosensor.com/xe/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00286Nucleic acid-PCRRT-PCR90 http://sdbiosensor.com/xe/product/7653Positive controlPositive control (2019-nCoV) and internal control, not specifiedNegative controlnegative control, not specifiedThroughputsingle tubes97standard for SARS-CoV-257BioRadUnited Stateswww.bio-rad.com/NoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:0067Nucleic acid-PCRRT-PCR262SrongStep Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit160Liming Bio-Products Co., LtdChinawww.limingbio.com/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00211Nucleic acid-PCRRT-PCRPositive controlInternal Control (IC) amplifying human Rnase P geneThroughputsingle tubes886SOLIScript 1-step CoV Kit490Solis BiodyneEstoniawww.solisbiodyne.comNoCommercialisedNoNoAutomatedManualNucleic acid2021-05-10 13:04:00697Nucleic acid-PCRRT-PCRCrossreactivity no cross-reactivity with anti-Influenza Avirus, anti-Mycoplasma pneumoniae,anti-Streptococcus pneumoniaeand anti-HCV Type of antigenNucleoprotein853SMARTCHEK SARS-CoV2 Detection Kit106Genesystem, Co. LtdSouth Koreawww.genesystem.co.kr/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00677Nucleic acid-PCRRT-PCR45Positive controlPositive control not specifiedNegative controlWaterThroughput4181SMARTCHECK SARS-CoV2 Detection Kit106Genesystem, Co. LtdSouth Koreawww.genesystem.co.kr/NoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00139Nucleic acid-PCRRT-PCR471Simplexa COVID-19 Direct RT-PCR Kit511DiaSorin S.p.AItalywww.diasorin.com/YesCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:18:20378Nucleic acid-PCRRT-PCR60 https://molecular.diasorin.com/international/kit/simplexa-covid-19-direct-kit/ LOD500copies/mlClinical Sensitivity100%Clinical Specificity100%Throughputsingle tubes860Simcere Novel Coronavirus (2019-NCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)226OZO LifeUnited Kingdomwww.ozo.life/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00678Nucleic acid-PCRRT-PCR120 https://www.ozo.life/pcr-fluorescence-probingLOD200copies/mlThroughput96samples372Sherlock CRISPR SARS-CoV-2243Sherlock BiosciencesUnited Statessherlock.bio/NoIn developmentNoNoLab-basedNucleic acid2021-05-10 13:04:00306Nucleic acid-OtherCRISPR352Senteligo Covid-19 qRT PCR Detection Kit232Sente BiolabTurkeysentebiolab.com.tr/en/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00295Nucleic acid-PCRRT-PCR60 https://sentebiolab.com.tr/en/corona-virus-diagnostic-kit/Positive controlPositive control (not specified), internal control (Rnase P)Negative controlNegative control (not specified)Throughputsingle tubes1300Sentebiolab Senteligo SARS-CoV-2 (COVID-19) Multiplex qPCR Detection Kit643Eryigit Biomedical DevicesTurkeywww.eryigit.com.trYesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:001070Nucleic acid-PCRRT-PCR60 Information provided by the manufacturer: contains a Reaction Mix that contains the necessary enzymes, two different primer-probe sets that are specific for SARS-CoV-2, and an internal control primer-probe set that is used to validate the nucleic acid extraction and sample transportation efficiency to minimize false negatives. LOD50cpmPositive controlProvided with the kitNegative controlProvided with the kitAnalytical Sensitivity100%Analitical Specificity100%Clinical Sensitivity99%Clinical Specificity99%Throughput96samples/run323SensDtect RT-qPCR SARS CoV-2210Promis DiagnosticsUnited Stateswww.promisdx.com/NoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00271Nucleic acid-PCRRT-PCR748SDI SARS-CoV-2 Assay446Specialty Diagnostic (SDI) LaboratoriesUnited Statessdilabsinc.com/NoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00606Nucleic acid-PCRRT-PCR529SCVR-2122 AccuPower SARS-CoV-2 Real-Time RT-PCR Kit (50 tests)324BIONEER CorporationSouth Koreawww.bioneer.com/NoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00431Nucleic acid-PCRRT-PCR746ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit443ScienCell Research LaboratoriesUnited Stateswww.sciencellonline.com/NoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00603Nucleic acid-PCRRT-PCR800SBC SARS-CoV-2 qPCR Kit464Schweitzer Biotech Company LtdChinasbc-biotech.comYesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00642Nucleic acid-PCRRT-PCR90 http://covid19.sbc-biotech.com/sbc-sars-cov-2-qpcr-kit/LOD10copies/μl801SBC SARS-CoV-2 Convective PCR Diagnostic Device/Kit464Schweitzer Biotech Company LtdChinasbc-biotech.comNoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00643Nucleic acid-PCRRT-PCR799SBC RNP qPCR Kit464Schweitzer Biotech Company LtdChinasbc-biotech.comNoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00641Nucleic acid-PCRRT-PCR1330SARS-CoV2 RT-PCR410Monocent, IncUnited Stateswww.monocent.comYesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:001099Nucleic acid-PCRRT-PCR1109SARS-CoV-2/SARS-CoV Multiplex REAL-TIME PCR Detection Kit592Russiasite.dna-technology.ru/YesCommercialisedNoNoManualNucleic acidhttp://site.dna-technology.ru/files/images/instructions_eng/617-2_SARS-CoV,%20SARS-CoV-2%20Multiplex_%D0%92%D0%9A_S_IVD_b_CE_2020-05-07.pdf; samples: RNA extracted from nasopharynx and oropharynx swabs, bronchoalveolar lavage, endotracheal aspirate, nasopharyngeal aspirate, sputum http://site.dna-technology.ru/eng/new/1/32.html2021-05-10 13:04:00887Nucleic acid-PCRRT-PCR40 information provided by manufacturer +website (http://site.dna-technology.ru/files/images/instructions_eng/617-2_SARS-CoV,%20SARS-CoV-2%20Multiplex_%D0%92%D0%9A_S_IVD_b_CE_2020-05-07.pdf)LOD10copies/reactionPositive controlPositive control included. It is a cloned part of the virus genome.It is produced with genetic engineering techniques and characterized by automatic sequencing. The kit includes the Internal control (RNA-IC). RNA-IC is intended to assess the quality of tNegative controlPhysiological saline solution can be used as a negative control sample in volumes indicated in supplied instructions. A negative control sample should go through all stages of RNA extraction. Clinical Sensitivity100%Clinical Specificity100%Throughput96%1821SARS-CoV-2/FluA/FluB/RSV detection kit（PCR MALDI-TOF-MS）828Shanghai Conlight Medical Lab Co., Ltd.Chinawww.kanglijianyan.comYesCommercialisedNoNoChipLab-basedNucleic acidNasal swabNasopharyngeal swabSARS-CoV-2/FluA/FluB/RSV test is a rapid, multiple Nucleic acid amplification testing.This detection intended for the qualitative detection and differentiation of SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV) viral RNA in either nasopharyngeal swab or nasal swab specimens collected from individuals suspected of respiratory viral infection. The product is registered as an in vitro diagnostic under number: SARS-CoV-2/FluA/FluB/RSV detection kit (PCR MALDI-TOF-MS) (no brand name) (NL-CA002-2021-55817)2021-05-10 13:04:001499Nucleic acid-PCROtherQualitativeMultipleOther120resin and Spectro CHIP ( details see instructment of the kit )LOD2750cpmPositive controlAble to detect all of SARS-CoV-2, FluA, FluB, RSV, MS2 bacterphage and RNase P.Negative controlMS2 bacterphage should be detected,and all of SARS-CoV-2, FluA, FluB, RSV should be detected as notAnalytical Sensitivity100%Analitical Specificity100%Clinical Sensitivity94.3%Clinical Specificity100%46SARS-CoV-2, Influenza and RSV 8-well29AusDiagnosticsAustraliawww.ausdiagnsotics.com/NoCommercialisedNoNoLab-basedNucleic acidno cross-reactivity was detected in a 17 fungal pathogen multiplex using 200 blood culture specimens2021-05-10 13:04:0034Nucleic acid-PCRRT-PCRhttps://www.ausdx.com/qilan/Products/20081-r01.1.pdfLOD17.3copies/μl(SARS-CoV-2a LOD0.7copies/μl(SARS-CoV-2b )Analytical Sensitivity100%(SARS-CoV-2a )Analytical Sensitivity97.7%(SARS-CoV-2b )Analitical Specificity100%(SARS-CoV-2a )Type of antigenSARS-CoV-2 spike protein296SARS-CoV-2 Virus Detection Diagnostic Kit (RT- qPCR Method)187Ningbo Health Gene Technologies Co. LtdChinawww.healthgenetech.net/NoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00244Nucleic acid-PCRRT-PCR1132SARS-CoV-2 Triplex PCR kit598Astra Biotech GmbHGermanyastrabiotech.de/eng/YesCommercialisedNoNoManualNucleic acidEndogeneous internal control (transcript of one of human «housekeeping genes»); targets ORF1ab, ORF8, and N protein coding regions; nasopharyngeal swabs, oropharyngeal swabs and saliva samples; Diagnostic Sensitivity 100%; Diagnostic Specificity 100% https://astrabiotech.de/eng/products/molekulargenetische_diagnostik/sars-cov-2_/sars-cov-2_triplex/2021-05-10 13:04:00913Nucleic acid-PCRRT-PCR90 Information provided by manufacturer + websitePositive controlincluded (in vitro transcribed RNA of target regions: ORF1ab, ORF8, and N protein)Negative controlincludedAnalytical Sensitivity1000 copies of SC2 genomic RNA per 1 mL of sample Clinical Sensitivity100%Clinical Specificity100%Throughput100 tests441SARS-CoV-2 Test Kit278Xiamen Zeesan Biotech Co., LtdChinawww.zeesandx.com/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00352Nucleic acid-PCRRT-PCR http://www.zeesandx.com/products/sars-cov-2-test-kit-real-time-pcr.html207SARS-COV-2 test125Hackensack Meridian Health CDIUnited Stateshmh-cdi.org/NoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00164Nucleic acid-PCRRT-PCR708SARS-CoV-2 Test397BiocernaUnited Stateswww.biocerna.com/NoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00546Nucleic acid-PCRRT-PCR 719SARS-CoV-2 Test428Exact SciencesUnited Stateswww.exactsciences.com/NoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00585Nucleic acid-PCRRT-PCR1368SARS-COV-2 RT-qPCR Assay126Hangzhou AllTest Biotech Co., LtdChinawww.alltests.com.cn/YesCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:001136Nucleic acid-PCRNoRT-PCR100LOD200copies/mlPositive controlRAN PseudovirusNegative controlDEPC-Treated WaterAnalytical Sensitivity100%Analitical Specificity99.14%Clinical Sensitivity100%Clinical Specificity99.14%Throughput96samples/run1388SARS-COV-2 RT-qPCR Assay659CITEST DIAGNOSTICS INCCanadawww.citestdiagnostics.com/YesCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:001154Nucleic acid-PCRNoRT-PCR100 LOD200AUPositive controlRAN PseudovirusNegative controlDEPC-Treated WaterAnalytical Sensitivity100%Analitical Specificity99.14%Clinical Sensitivity100%Clinical Specificity99.14%Throughput96samples/run1693SARS-COV-2 RT-qPCR Assay890Acro Biotech IncUnited Stateswww.acrobiotech.comYesCommercialisedNoNoAutomatedManualNucleic acid2021-05-10 13:18:201372Nucleic acid-PCRRT-PCR100 https://www.acrobiotech.com/covid-19-testsLOD200AUPositive controlRAN PseudovirusNegative controlDEPC-Treated WaterAnalytical Sensitivity100%Analitical Specificity99.14%Clinical Sensitivity100%Clinical Specificity99.14%Throughput96samples/run380SARS-CoV-2 RT-PCR test249Stanford Clinical Virology LaboratoryUnited Statesmed.stanford.edu/pathology.htmlNoIn developmentNoNoLab-basedNucleic acid2021-05-10 13:04:00312Nucleic acid-PCRRT-PCR713SARS-CoV-2 RT-PCR test402Children's Hospital of Philadelphia Infectious Disease Diagnostics LaboratoryUnited Stateswww.chop.edu/centers-programs/infectious-disease-diagnostics-laboratoryNoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00551Nucleic acid-PCRRT-PCR630SARS-CoV-2 RT-PCR374Vitro SASpainwww.vitro.bio/YesCommercialisedNoNoLab-basedNucleic acidNasopharyngeal swab2021-05-10 13:04:00518Nucleic acid-PCRRT-PCRQualitative http://www.vitro.bio/Covid-19/inicioLOD10copies/reactionType of antigennucleoprotein2004SARS-COV-2 RESPI R-GENE56bioMérieux SAFrancewww.biomerieux.com/YesCommercialisedNoNoManualNucleic acidNasopharyngeal swabN/A2021-05-10 13:04:001681Nucleic acid-PCRRT-PCRQualitative90LOD380cpmPositive controlPositive control includedNegative controlNegative control included426SARS-COV-2 REALTIME PCR KIT78Vircell S.L.Spainwww.vircell.com/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00345Nucleic acid-PCRRT-PCR90 https://en.vircell.com/media/filer_public/cd/02/cd02c5e3-a83f-4b51-8d86-fcd011aa5d4b/sars-cov-2_realtime_pcr_kit_pme098-0420.pdfLOD50copies/tubeAnalytical Sensitivity100%Analitical Specificity100%487SARS-CoV-2 Real-TM299Sacace BIOTECNOLOGIESItalysacace.com/YesCommercialisedNoNoManualNucleic acidhttps://www.mpbio.com/media/productattachment/DX092020-EN-Assure-Sars-CoV-2-IgG-IgM-Rapid-Test-0743142-Flyer.pdf; https://www.mpbio.com/media/productattachment/DX052020-EN-ASSURE-SARS-CoV-2-IgG-IgM-Rapid-Test-IFU.pdf 2021-05-10 13:04:00388Nucleic acid-PCRRT-PCR https://sacace.com/new-kit-covid-19-sars-cov-2.htmClinical Sensitivity99%Clinical Specificity95%Type of antigenSARS-CoV-2 recombinant proteins59SARS-CoV-2 Real-Time RT-PCR Kit36Chinawww.biochemgroup.net/NoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:0041Nucleic acid-PCRRT-PCR1666SARS-CoV-2 Real-time RT-PCR Kit117Goldsite Diagnostics IncChinaen.goldsite.com.cn/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:18:201345Nucleic acid-PCRRT-PCR90 LOD500cpmPositive controlProvided in the kitNegative controlProvided in the kitAnalytical Sensitivity100%Analitical Specificity100%Clinical Sensitivity96.8%Clinical Specificity100%Throughput96 samples per run1131SARS-CoV-2 Real-Time RT-PCR Assay124Guangzhou Wondfo Biotech Co., LtdChinaen.wondfo.com.cn/YesCommercialisedNoNoAutomatedManualNucleic acid2021-05-10 13:04:00912Nucleic acid-PCRRT-PCRPositive control ORF1ab and N89SARS-CoV-2 Real Time PCR LAB-KIT52BIOMAXIMA S.A.Polandwww.biomaxima.com/YesCommercialisedNoNoManualNucleic acidDeclared as "Validated and registered in URPL" (Poland) 2021-05-10 13:04:0062Nucleic acid-PCRRT-PCR62LOD? 10 RNA copiesPositive controlpositive control, not specifiedNegative controlnegative control, not specifiedAnalytical Sensitivity99% 99%)]]>Analitical Specificity99% 99%)]]>ThroughputSingle tubes974SARS-CoV-2 Real Time PCR Kits522RTATurkeyrtalabs.com.tr/en/YesCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00761Nucleic acid-PCRRT-PCR http://a1lifesciences.com.tr/Content/uploads/Diagnovital_SARS-CoV-2_Specifications.pdfLOD100copies/mlClinical Sensitivity100%Clinical Specificity100%526SARS-COV-2 R-GENE (ref 432720)56bioMérieux SAFrancewww.biomerieux.com/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00428Nucleic acid-PCRRT-PCR90 https://www.biomerieux-diagnostics.com/sars-cov-2-r-geneLOD380copies/mlPositive controlPositive control not specifiedNegative controlNegative control not specifiedThroughputsingle tubes1862SARS-CoV-2 PLUS ELITe MGB® Kit852ELITechGroupFrancewww.elitechgroup.comYesCommercialisedNoNoCartridgeCassetteMicroplateAutomatedFully automated (robot)Lab-basedSemi-automatedNucleic acidNasal swabNasopharyngeal swabOropharyngeal swabMultiplex assay detecting SARS-CoV-2 in combination with Flu A, Flu B, RSV. Endogenous internal control RNase_P Validated in combination with S2R platform ELITe InGenius®2021-05-10 13:04:001539Nucleic acid-PCRYesRT-PCRQualitative150LOD111cpmPositive controlSARS-CoV-2 PLUS – ELITe Positive ControlNegative controlMolecular Biology grade waterClinical Sensitivity100%Clinical Specificity100%717SARS-CoV-2 PCR Test421Diatherix Eurofins LaboratoryUnited Stateseurofins-diatherix.com/NoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00576Nucleic acid-PCRN.A.RT-PCR753SARS-CoV-2 PCR test448Yale New Haven Hospital Clinical Virology LaboratoryUnited Statesmedicine.yale.edu/labmed/sections/virology/NoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00608Nucleic acid-PCRRT-PCR822SARS-CoV-2 PCR Reagent Kit475GFEGermanywww.gfeblut.deNoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00658Nucleic acid-PCRRT-PCR1400SARS-COV-2 PANEL664Assurance Scientific LaboratoriesUnited Stateswww.assurancescientificlabs.comNoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:001164Nucleic acid-PCRRT-PCRLOD29copies/sampleClinical Sensitivity100%Clinical Specificity100%1927SARS-CoV-2 One-Step RT-PCR Kit880NZYTechPolandwww.nzytech.comYesCommercialisedNoNoManualNucleic acidOtherAssay validated on widely used qPCR instruments including ABI® 7500, ABI® StepOnePlus™, ABI® QuantStudio™ 6, Bio-Rad® CFX96, Qiagen® Rotor-Gene Q, Roche® LC 480 II. NZYTech SARS-CoV-2 One-Step RT-PCR Kit, RdRp and N genes (IVD) provides the complete set of reagents and probes to qualitatively detect the SARS-CoV-2 genome, through common realtime PCR platforms. The virus RNA dependent RNA polymerase (RdRp) and the Nucleocapsid phosphoprotein (N) genes have previously been identified as highly specific markers for SARS-CoV-2. This NZYTech kit targets specific regions in the RdRp and N genes of SARS-CoV-2 genome to provide the highest sensitivity of detection.2021-05-10 13:04:001603Nucleic acid-PCRRT-PCR90target RdRp and N GenesLOD0.15cpuPositive controlNegative controlClinical Sensitivity100%Clinical Specificity100%1859SARS-CoV-2 Nucleic Acid Test Kit (PCR-Fluorescence Probe Method)319Beijing Lepu Medical Technology Co., LtdChinaen.lepumedical.com/YesCommercialisedNoNoManualNucleic acidNasopharyngeal swabOtherNO2021-05-10 13:18:201538Nucleic acid-PCROtherfluorescence detectionPositive control96.6%Clinical Sensitivity92%Clinical Specificity100%431SARS-CoV-2 nucleic acid test kit273Wuhan Easydiagnosis Biomedicine Co., LtdChinawww.mdeasydiagnosis.com/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00347Nucleic acid-PCRRT-PCR http://www.mdeasydiagnosis.com/products/InternationalTrade/88.htmlType of antigennucleoprotein1578SARS-CoV-2 Nucleic Acid Test Kit455Assure Tech. (Hangzhou) Co., LtdChinawww.diareagent.com/YesCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:001257Nucleic acid-PCRNoRT-PCR78 http://www.diareagent.com/product_list.htmlLOD500AUClinical Sensitivity100%204SARS-CoV-2 Nucleic Acid Test (LAMP)123Guangzhou Tebsun Bio-Tech Development Co., LtdChinawww.tebsun.com/NoCommercialisedNoNoAutomatedLab-basedNear POC / POCNucleic acid2021-05-10 13:04:00161Nucleic acid-PCRLAMP361SARS-CoV-2 Nucleic Acid Test239Shanghai Kehua Bio-engineering Co., LtdChinawww.skhb.com/NoCommercialisedNoNoManualNucleic acid http://www.aebrapidtest.com/index.php/product-details/ab-rapid-test-covid-19-igg-igm/#details 2021-05-10 13:04:00302Nucleic acid-PCRRT-PCR1364SARS-CoV-2 Nucleic Acid RT-PCR Test Kit413Hangzhou Clongene Biotech Co., LtdChinaen.clongene.com/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:001123Nucleic acid-PCRRT-PCR120 http://en.clongene.com/uploads/20201105/e4bd4de7b5f31428c79068cf4eda2876.pdfLOD500cpmPositive controlRecombination DNA of SARS-CoV-2 Negative controlNaClAnalytical Sensitivity100%Analitical Specificity100%Clinical Sensitivity96.92%Clinical Specificity99.27%Throughput48 samples per run64SARS-CoV-2 Nucleic Acid Detection Kit (RT-qPCR with Taqman-Probe)39Beijing Genskey Medical Technology Co., LtdChinawww.genskey.com/NoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:0046Nucleic acid-PCRRT-PCR638SARS-CoV-2 Nucleic Acid Detection Kit (PCR-Fluorescent Probe Method)384Zybio IncChinawww.zybio.com/enYesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00529Nucleic acid-PCRRT-PCR https://www.zybio.com/en/Product/Molecule/2020-03-24/513.htmlLOD200copies/mlThroughputsingle tubesType of antigennucleocapsid antigen1750SARS-CoV-2 Nucleic Acid Detection Kit (Multiplex Real Time RT-PCR )782TransGen Biotech Co., Ltd.Chinawww.transgenbiotech.com/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:001428Nucleic acid-PCRRT-PCR60LOD0.5copies/μlPositive controlIn vitro transcribed RNA for ORF1ab, N genes and the internal control-RP geneNegative controlRNase-free WaterAnalytical Sensitivity100%Analitical Specificity100%Clinical Specificity97%Clinical Specificity98%Throughput96samples/run1287SARS-CoV-2 Nucleic Acid Detection Kit (Fluorescence RT-PCR)641HANGZHOU BIOER TECHNOLOGY CO., LtdChinawww.bioer.com.cn/en/YesCommercialisedNoNoAutomatedManualNucleic acidhttp://www.bioer.com.cn/en/news/472.html http://www.bioer.com.cn/en/news/472.html2021-05-10 13:04:001061Nucleic acid-PCRRT-PCRFluorescence98SARS-CoV-2 Negative57BioRadUnited Stateswww.bio-rad.com/NoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:0068Nucleic acid-PCRRT-PCR459SARS-CoV-2 in the Open System Reagents for BD MAX284BioGXUnited Statesbiogx.com/NoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00370Nucleic acid-PCRRT-PCR272SARS-CoV-2 Fluorescent PCR168Maccura Biotechnology Co., LtdChinawww.maccura.com/enYesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00224Nucleic acid-PCRRT-PCR120 https://www.maccura.com/resources/98099844450616688.pdfLOD1000copies/mlPositive controlEvaluatedNegative controlEvaluatedClinical Sensitivity99.56%Clinical Specificity99.35%Throughputsingle tubes406SARS-CoV-2 E, RdRP or N gene CE-IVD 7 virus Respiratory Panel multiplex RT-PCR263TIB Molbiol/Roche DiagnosticsGermanywww.tib-molbiol.com/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00330Nucleic acid-PCRRT-PCRManual NAT 709SARS-CoV-2 Droplet Digital PCR (ddPCR) test398BiodesixUnited Stateswww.biodesix.com/NoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00547Nucleic acid-PCRDigital-PCR 273SARS-CoV-2 DETECTR169Mammoth BiosciencesUnited Stateswww.mammoth.bio/NoIn developmentNoNoManualNucleic acid2021-05-10 13:04:00225Nucleic acid-OtherCRISPR191Sars-CoV-2 Detection Kit on portable PCA Analyzer113GNA Biosolutions GmbHGermanywww.gna-bio.com/NoIn developmentNoNoLab-basedNucleic acid2021-05-10 13:04:00148Nucleic acid-PCRRT-PCR45SARS-COV-2 Detection Kit for the VERSA Viral Detection workstation28Aurora Biomed IncCanadawww.aurorabiomed.com/NoIn developmentNoNoLab-basedNucleic acid2021-05-10 13:04:0033Nucleic acid-PCRRT-PCR1405SARS-CoV-2 Detection Kit (qPCR Probe Assays)667Jiangsu CoWin BiotechChinawww.cwbiosciences.comYesCommercialisedNoNoLab-basedNucleic acidBronchoalveolar lavage fluidNasopharyngeal swabSputum https://www.cwbiosciences.com/news/info/id/12.html2021-05-10 13:04:001168Nucleic acid-PCRRT-PCR50 https://www.cwbiosciences.com/uploads/20200312/fa4003cce2271bf3b6790c6c3467c8d1.pdf;LOD1000copies/mlPositive controlplasmid carrying target genes (ORF1ab and N gene)Negative controlempty plasmid727SARS-CoV-2 Assay434Integrity LaboratoriesUnited Statesintegritylaboratories.com/NoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00592Nucleic acid-PCRRT-PCR739SARS-CoV-2 Assay439Nationwide Children's HospitalUnited Stateswww.nationwidechildrens.org/NoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00598Nucleic acid-PCRRT-PCRType of antigenenvelope antigens99SARS-CoV-2 / COVID-19 Assa57BioRadUnited Stateswww.bio-rad.com/NoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:0069Nucleic acid-PCRRT-PCR250SARS-CoV-2 (Covid-19) Real-Time PCR Kit (as per CDC Atlanta guidelines)153KRISHGEN BioSystemsUnited Stateswww.krishgen.com/YesCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00202Nucleic acid-PCRRT-PCRWHO-7 https://krishgen.com/idh9eknj/uploads/products/1585660551KBRT010_SARS-Cov-2%20Coronavirus%20Real-time%20RT-PCR_RT-qPCR_Detection_Kit_ver2.2.pdfPositive controlPositive control (non-infectious DNA), Human specimen extraction Control (HSC)231SARS-CoV-2 (2019-nCoV) CDC qPCR Probe Assay143Integrated DNA Technologies/DanaherUnited Stateseu.idtdna.com/pagesNoIn developmentNoNoLab-basedNucleic acid2021-05-10 13:04:00183Nucleic acid-PCRRT-PCR921SARS-CoV- RT-PCR Detection Kit505Bio Basic IncCanadawww.biobasic.comYesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00725Nucleic acid-PCRRT-PCR https://www.biobasic.com/amfilerating/file/download/file_id/25636/LOD1000copies/reactionClinical Specificity100%947SARS-CoV- Nucleic Acid Test Kit (RT-PCR)469Shenzhen GeneBioHealth Co., LtdChinawww.genebiohealth.com/en/YesCommercialisedNoNoManualNucleic acid Positive coincidence rate IgM and IgG: 82% and 92%; Negative coincidence rate IgM and IgG: 94% and 97%; Total coincidence rate IgM and IgG: 92.30% and 96.30% 2021-05-10 13:04:00747Nucleic acid-PCRRT-PCR http://www.genebiohealth.com/en/col.jsp?id=178LOD300copies/ml147SAMBA II COVID-19 Test (near-POC NAT)84Diagnostics for the Real World LtdUnited Stateswww.drw-ltd.com/drw/about-drw.htmlYesCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00107Nucleic acid-PCRRT-PCR90 https://www.cam.ac.uk/research/news/rapid-covid-19-diagnostic-test-developed-by-cambridge-team-to-be-deployed-in-hospitalsClinical Sensitivity98.7%Clinical Specificity100%1110SaliVIR Rapid Multiplex COVID19 vRNA Test593Chronomics LimitedUnited Kingdomwww.chronomics.com/YesCommercialisedNoNoAutomatedManualNucleic acid https://www.chronomics.com/lab-products/end-to-end-product2021-05-10 13:04:00889Nucleic acid-PCRRT-PCR39 Information provided by manufacturer + websiteLOD0.75copies/μlPositive control2019-nCoV nucleocapsid gene and 2019-nCoV envelope geneNegative controlHuman RPP30 geneAnalitical Specificity100%1181SaliVIR COVID 19 Rapid Multiplex qRT-PCR Kit593Chronomics LimitedUnited Kingdomwww.chronomics.com/YesCommercialisedNoNoAutomatedManualNucleic acidEnd-to-end CE marked IVD for the detection of SARS-CoV-2 viral RNA from saliva and nasopharyngeal swabs.Saliva collection can be performed with or without the supervision of a healthcare professional. Product includes saliva collection devices (if required), reagents (RNA extraction and qRT-PCR kits) and software (sampling and reporting modules via online platform). The SaliVIR COVID19 Rapid Multiplex qRT-PCR Kit comprises only primers and probes designed by the CDC from the CDC 2019-Novel Coronavirus (2019-CoV) Real-Time RT-PCR Diagnostic Panel (assays N1 and RP) and by Cortman et al. from the Charité Berlin WHO protocol (assay E) without any changes. Analytical specificity (cross-reactivity) of these diagnostic panels has been previously established. https://www.chronomics.com/lab-products/end-to-end-product; https://content.chronomics.com/hubfs/COVID/SaliVIR%20COVID19%20Rapid%20Multiplex%20qRT-PCR%20Protocol%20v1.0.1.pdf2021-05-10 13:04:00963Nucleic acid-PCRRT-PCR information provided by the manufacturer + website: multiplex of primer / probe assays which target the nucleocapsid gene (assay N1) and the envelope gene (assay E) of SARS-CoV-2; and the human RPP30 gene (assay RP) used as internal RNA extraction control. Two plasmid controls are also included in the kit to confirm functionality of the assays and the qRT-PCR reaction: the RPP30 Negative Control and the combined 2019-nCoV nucleocapsid gene and 2019-nCoV envelope gene Positive Control. The kit also contains ROX reference dye at 10x concentration for use with real-time quantitative PCR (qPCR) instruments that require it. LOD750copies/mlPositive control2019-nCoV nucleocapsid gene and 2019-nCoV envelope geneNegative controlHuman RPP30 geneAnalytical Sensitivity100%1177Saliva/Swab RNA Purification 96-Well Kit Dx (Cat#Dx69300)189Norgen Biotek Corp.Canadanorgenbiotek.com/YesCommercialisedNoNoOtherNucleic acidSaliva https://norgenbiotek.com/product/salivaswab-rna-purification-96-well-kit-dx2021-05-10 13:04:00959OtherOtherPurification test Information provided by the manufacturer: Norgen’s Saliva/Swab RNA Purification 96-Well Kit Dx provides a rapid high throughput method for the purification of total RNA from non-preserved saliva and nasal/throat swabs, and from preserved saliva collected on Norgen’s Saliva RNA Collection and Preservation Devices Dx (Cat. 53800) or preserved swabs collected in Norgen’s Total Nucleic Acid Preservative Tubes Dx (Cat. Dx69200). Purification is based on using Norgen’s proprietary resin separation matrix. RNA is preferentially purified from other cellular components such as proteins, without the use of phenol or chloroform. The chemistry employed in the kit allows the purification of total RNA, including viral and bacterial RNA, irrespective of size or GC content. The purified RNA is ideal for in vitro diagnostic use for medical purposes.This kit is optimized to be used with any downstream application employing enzymatic amplification or other enzymatic modifications of RNA followed by signal detection or amplification. Any diagnostic results generated using the RNA isolated with Norgen’s Saliva / Swab RNA Purification 96-Well Kit Dx in conjunction with an in vitro diagnostic assay should be interpreted with regard to other clinical or laboratory findings1174Saliva RNA Collection and Preservation Devices Dx (Cat#53800)189Norgen Biotek Corp.Canadanorgenbiotek.com/YesCommercialisedNoNoOtherNucleic acid https://norgenbiotek.com/product/saliva-rna-collection-and-preservation-devices-dx-02021-05-10 13:04:00955OtherOtherSample collection device Information provided by the manufacturer: Norgen’s Saliva RNA Collection and Preservation Devices Dx are designed for 1) safe and non-invasive saliva collection and 2) preservation of RNA in saliva samples at ambient temperature. Each of the 50 Saliva RNA Collection and Preservation Devices Dx consists of 3 components: (1) Saliva Collection Funnel and Collection Tube, (2) Collection Tube Cap, and (3) Norgen’s Saliva RNA Preservative contained within a sealed squeezable ampoule. After collecting the required volume of saliva the Collection Funnel is removed and the contents of the Preservative Ampoule are then added and mixed with the collected saliva. The Saliva Collection Tube is subsequently sent to the laboratory for RNA isolation and analysis. Each of Norgen’s Collection Tubes is labeled with a unique serial number that can be used for secure and anonymous tracking of the sample. The saliva RNA in preserved samples is stable for up to 2 months at room temperature. This kit is ideal for collecting and preserving RNA samples for in vitro diagnostic use for medical purposes.Norgen’s Saliva RNA Collection and Preservation Devices Dx do not provide a diagnostic result. It is the sole responsibility of the user to use and validate these devices in conjunction with a downstream in vitro diagnostic assay.1176Saliva / Swab RNA Purification Kit Dx (Cat#Dx69100)189Norgen Biotek Corp.Canadanorgenbiotek.com/YesCommercialisedNoNoOtherNucleic acidSaliva https://norgenbiotek.com/product/saliva-swab-rna-purification-kit-dx2021-05-10 13:04:00958OtherOtherPurification testInformation provided by the manufacturer: Norgen’s Saliva/Swab RNA Purification Kit Dx provides a rapid method for the purification of total RNA from non-preserved saliva and nasal/throat swabs, and from preserved saliva collected on Norgen’s Saliva RNA Collection and Preservation Devices Dx (Cat. 53800) or preserved swabs collected in Norgen’s Total Nucleic Acid Preservative Tubes Dx (Cat. Dx69200). Purification is based on using Norgen’s proprietary resin separation matrix. RNA is preferentially purified from other cellular components such as proteins, without the use of phenol or chloroform. The chemistry employed in the kit allows the purification of total RNA, including viral and bacterial RNA, irrespective of size or GC content. The purified RNA is ideal for in vitro diagnostic use for medical purposes. This kit is optimized to be used with any downstream application employing enzymatic amplification or other enzymatic modifications of RNA followed by signal detection or amplification. Any diagnostic results generated using the RNA isolated with Norgen’s Saliva 1332rTEST COVID-19/FLU qPCR DIAGNOSTIC KIT580MultiplexDXUnited Stateswww.multiplexdx.com/YesCommercialisedNoNoAutomatedManualNucleic acid2021-05-10 13:04:001101Nucleic acid-PCRRT-PCR81 https://www.multiplexdx.com/products/rtest-covid-19-flu-qpcr-diagnostic-kitLOD3cprrange: 2-4Positive controlThe PC4.01 consists of lyophilized isolated genomic RNA of SARS-CoV-2, IAV, IBV spiked with RNase PNegative controlThe NTC consists of using nuclease-free water (PCR water) in the RT-qPCR reactions instead of RNAAnalytical Sensitivity100%Analitical Specificity100%Clinical Sensitivity100%Clinical Specificity100%Throughput96samples/run1315rTest COVID-19 qPCR MULTIPLEX580MultiplexDXUnited Stateswww.multiplexdx.com/YesCommercialisedNoNoAutomatedManualNucleic acid2021-05-10 13:04:001085Nucleic acid-PCRN.A.RT-PCR81 https://www.multiplexdx.com/products/rtest-covid-19-qpcr-multiplexLOD2cprPositive controlThe PC-BMC5 consists of lyophilized isolated genomic RNA of SARS-CoV-2 spiked with human RNANegative controlThe NTC consists of using nuclease-free water (PCR water).Analytical Sensitivity100%Analitical Specificity100%Clinical Sensitivity100%Clinical Specificity100%Throughput96samples/run1692rTest COVID-19 qPCR ALLPLEX Kit580MultiplexDXUnited Stateswww.multiplexdx.com/YesCommercialisedNoNoAutomatedManualNucleic acid2021-05-10 13:04:001371Nucleic acid-PCR81 https://www.multiplexdx.com/products/rtest-covid-19-qpcr-allplexLOD4cprPositive controlPC BMC5 consists of isolated genomic RNA of SARS-CoV-2 spiked with human RNANegative controlPCR water nuclease freeAnalytical Sensitivity100%Analitical Specificity100%Clinical Sensitivity100%Clinical Specificity100%Throughput96samples/run2027rTEST COVID-19 qPCR Allplex931MultiplexDX s.r.o.Slovakiawww.multiplexdx.comYesCommercialisedNoNoManualNucleic acidNasopharyngeal swabSalivaThroat swabThe rTEST COVID-19 qPCR Allplex kit is a qualitative in vitro diagnostic test designed to detect the presence of SARS-CoV-2 genetic material in biological samples obtained primarily from the human upper airways (nose and nasopharynx). The kit is intended exclusively for use in a diagnostic laboratory with the appropriate equipment, safety standards, and properly trained personnel. The rTEST COVID-19 qPCR Allplex kit is among the first fully room temperature stable diagnostic kits to detect genomic RNA of SARS-CoV-2.2021-05-10 13:04:001705Nucleic acid-PCRYesRT-PCRQualitativeMultipleOther80LOD4cprPositive controlPC BMC5 consists of isolated genomic RNA of SARS-CoV-2 spiked with human RNANegative controlPCR waterAnalytical Sensitivity100%Analitical Specificity100%Clinical Sensitivity100%Clinical Specificity100%200RT-qPCR based SARS-CoV-2 detection kit with SPRS (Spike-in Reference Standard)119Guangzhou FulenGen Co., LtdChinawww.fulengen.com/NoIn developmentNoNoManualNucleic acid2021-05-10 13:04:00157Nucleic acid-PCRRT-PCR952RT-PCR test kit for COVID-9 detection514UkrgentechUkrainewww.ukrgentech.com/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00749Nucleic acid-PCRRT-PCR https://www.ukrgentech.com/wp-content/uploads/2020/05/%D0%86%D0%BD%D1%81%D1%82%D1%80%D1%83%D0%BA%D1%86%D1%96%D1%8F-COVID-19-%D0%9A046-%D1%80%D0%B5%D0%B4%D0%B0%D0%BA%D1%86%D1%96%D1%8F-003-%D0%B2%D1%96%D0%B4-06.05.2020.pdf951RNAsure RNA Extraction Kit19Trivitron Healthcare Pvt. LtdIndiawww.trivitron.com/YesCommercialisedNoNoManualNucleic acidRNAsure Kit is designed for rapid manual and automated preparation of RNA from nasal/throat swabs The GENEDIA W COVID-19 Ag is an in vitro diagnostic single-use test and qualitative immunoassay to detect SARS-CoV-2 antigen in nasopharyngeal swab and sputum specimen from human. This assay is designed for professional personnel in laboratory and at point-of-care as an aid in screening patients suspected of being infected and asymptomatic patients. 2021-05-10 13:04:00748OtherOtherExtraction kit https://www.trivitron.com/products/covid-19/covid-19-testing-kits/rnasure---covid-19-rna-extraction-kit1120RNAsure - Covid-19 RNA Extraction Kit19Trivitron Healthcare Pvt. LtdIndiawww.trivitron.com/YesCommercialisedNoNoOtherNucleic acid https://secutronic.en.made-in-china.com/product-group/SqEneLFCnzVu/Rapid-Test-Kit-catalog-1.html Kit is based on Magnetic Bead Technology for extraction of RNA; for the Extraction of viral RNA f rom whole blood, Plasma, serum, CSF, Urine, nasal/Oral swabs collected in Viral Transport Medium (VTM), Cell culture supernatant, lymphocytes, tissues and other cell-f ree body fluids.; Yield is 85% recovery of the viral RNA.Time per batch of 48 extractions is 60 minutes. https://www.trivitron.com/products/covid-19/covid-19-testing-kits/rnasure---covid-19-rna-extraction-kit2021-05-10 13:04:00901Nucleic acid-OtherOtherExtraction kit https://www.trivitron.com/uploads/brochure/15972485713RNAsure_eBrochure_(1).pdf1851217R-Biopharm AGGermanyr-biopharm.com/YesCommercialisedNoNoOtherManualSemi-automatedNucleic acidNasal swabNasopharyngeal swabThroat swabFurther information regarding precision, analytical specificity and analytical reactivity can be found in IFU.2021-05-10 13:04:001531Nucleic acid-PCRYesRT-PCRQualitativeMultipleN.A.70LOD50cprPositive controlyesNegative controlyes332RIDA GENE SARS-CoV-2217R-Biopharm AGGermanyr-biopharm.com/NoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00279Nucleic acid-PCRRT-PCR810Rhonda Corona test471Spindiag GmbHGermanywww.spindiag.de/YesCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00114Respiratory Virus Nucleic Acid Detection Kit (Isothermal Amplification Chip Method)63CapitalBio TechnologyChinawww.capitalbiotech.com/en/index.htmlNoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:0079Nucleic acid-PCRRT-PCR202Respiratory Virus (IFVa/b + COVID-19) Real-Time PCR Kit121Guangzhou Hybribio Medicine Technology LtdHong Kong S.A.Rwww.hybribio.cn/NoIn developmentNoNoManualNucleic acid2021-05-10 13:04:00159Nucleic acid-PCRRT-PCR176Respiratory Pathogen Panel101GeneFirst LtdUnited Kingdomwww.genefirst.com/NoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00133Nucleic acid-PCRRT-PCR757Reliance One-Step RT-qPCR Supermix57BioRadUnited Stateswww.bio-rad.com/NoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00613Nucleic acid-PCRRT-PCR22RealStar SARS-CoV-2 RT-PCR Kit18Altona DiagnosticsGermanyaltona-diagnostics.comYesCommercialisedNoNoManualNucleic acidInstructions for Use at: https://altona-diagnostics.com/files/public/Content%20Homepage/-%2002%20RealStar/MAN%20-%20CE%20-%20EN/RealStar%20SARS-CoV-2%20RT-PCR%20Kit%201.0_WEB_CE_EN-S03.pdf 2021-05-10 13:04:0022Nucleic acid-PCRNoRT-PCR https://altona-diagnostics.com/en/products/reagents-140/reagents/realstar-real-time-pcr-reagents/realstar-sars-cov-2-rt-pcr-kit.htmlLOD1.00E-01 PFU/ml for both targets, the S gene and the E genePositive controlPositive Control contains both targets, B-?CoV and SARS-CoV-2. Internal control. Negative controlNegative control, not specifiedAnalytical SensitivityExpressed as LoDAnalitical SpecificityEnsured by the thorough selection of the oligonucleotides checked by sequence comparison analysis against publicly available sequences (B-?CoV, target E gene; SARSCoV-2, target S gene).ThroughputSingle tubes5REALQUALITY RQ-2019-nCoV4AB ANALITICA SrlItalywww.abanalitica.com/YesCommercialisedNoNoManualNucleic acidBased on WHO-5 2021-05-10 13:04:006Nucleic acid-PCRRT-PCR100 https://www.abanalitica.com/catalogo/files/1776.pdfPositive controlInternal control (additional assay) not specifiedPositive control, but not specifiedThroughputSingle tubes1459RealLine SARS-CoV-2 lyo REF VBD5580679BIORON Diagnostics GmbHGermanywww.bioron.deYesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:001211Nucleic acid-PCRRT-PCR90 https://www.bioron.de/product/rl-sars-cov-2-lyo/LOD25cprPositive controlPositive Control for SARS-Cov-2 is includedNegative controlNegative control is included in validated NA extraction kitsAnalytical Sensitivity100%Analitical Specificity100%Clinical Sensitivity100%Clinical Specificity100%Throughput96samples/run1460RealLine SARS CoV-2679BIORON Diagnostics GmbHGermanywww.bioron.deYesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:001212Nucleic acid-PCRRT-PCR100 https://www.bioron.de/product/rl-sars-cov-2/LOD10cprPositive controlincluded in the kit, also internal control sampleNegative controlincluded in the validated NA extraction kitAnalytical Sensitivity99%Analitical Specificity99%Clinical Sensitivity95%Clinical Specificity95%Throughput97samples/run322RealCycler CORO209Progenie Molecular S.L.U.Spainwww.progenie-molecular.com/en/index_IN.htmlYesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00270Nucleic acid-PCRRT-PCR https://www.progenie-molecular.com/en/RealCycler_Products_Formats_IN.html#header3-9gLOD1copies/μl1462RealBest RNA SARS-CoV-2680Vector-BestRussiawww.vector-best.ru/en/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:001213Nucleic acid-PCRRT-PCR100LOD25cprPositive controlPositive control for SARS-Cov-2 is includedNegative controlNegative control is included in validated NA extraction kitsAnalytical Sensitivity100%Analitical Specificity100%Clinical Sensitivity100%Clinical Specificity100%Throughput96samples/run591RealAccurate Quadruplex Corona-plus PCR Kit357PathoFinderNetherlandswww.pathofinder.com/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00481Nucleic acid-PCRRT-PCR150 https://www.pathofinder.com/realaccurate-products/pf0971b-rThroughputsingle tubes569Real-time RT-PCR Detection Kit For 2019-nCoV343Hangzhou Dian Biotechnology Co., LtdChinawww.dianbio.com/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00457Nucleic acid-PCRRT-PCRLOD1000copies/ml437Real-Time RT-PCR assays for the detection of SARS-CoV-2276Xi'an Goldmag Nanobio Tech Co., LtdChinawww.goldmag.com.cn/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00350Nucleic acid-PCRRT-PCR http://en.goldmag.com.cn/a/cp1/276.htmlLOD20copies/reactionPositive controlRegions of the nCoV N and ORF1abAnalytical Sensitivity100%920Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-250BGIChinawww.bgi.com/global/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00724Nucleic acid-PCRRT-PCR180 https://www.bgi.com/global/company/news/bgis-real-time-fluorescent-rt-pcr-kit-for-detecting-2019-ncov-was-listed-in-the-emergency-use-listing-of-who/LOD100copies/mlType of antigenS and N256Real time RT-PCR Kit for the detection of SARS-CoV-2156Landcent Europe B.V.Netherlandswww.landcent.nl/NoIn developmentNoNoManualNucleic acid2021-05-10 13:04:00207Nucleic acid-PCRRT-PCR393Real time RT-PCR Kit for the detection of SARS-CoV-2253Suzhou BTA Biotech Co. LtdChinaszbta.foodmate.net/NoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00316Nucleic acid-PCRRT-PCRType of antigenSARS-CoV-2 Nucleocapsid Protein101Real Time PCR Detection Kit For COVID-19 Coronavirus59Chinawww.bio2k.cn/YesCommercialisedNoNoManualNucleic acid The device is listed on the website but no info can be extracted2021-05-10 13:04:0071Nucleic acid-PCRRT-PCR1741Real SARS-CoV-2776OPERON, S.A.Spainoperon.es/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:001419Nucleic acid-PCRRT-PCR70LOD1.25cpuPositive controlE gene RNA, RdRp gene RNA, human GADPH gene RNANegative controlHuman GADPH gene RNAAnalytical Sensitivity95%Analitical Specificity95%Clinical Sensitivity98.5%Clinical Specificity96%Throughput96samples/run1742Real SARS-CoV-1/2776OPERON, S.A.Spainoperon.es/YesCommercialisedNoNoLab-basedNucleic acidInternal extraction, retrotranscription and amplification control included2021-05-10 13:04:001420Nucleic acid-PCRRT-PCR70LOD2.5cpuPositive controlE gene RNA, human GADPH gene RNANegative controlHuman GADPH gene RNAAnalytical Sensitivity95%Analitical Specificity95%Clinical Sensitivity100%Clinical Specificity97.5%Throughput96samples/run1127RapidScript SARS-CoV-2 Assay367MP BiomedicalsUnited Stateswww.mpbio.com/YesCommercialisedNoNoAutomatedManualNucleic acidNasopharyngeal swabs; Oropharyngeal swabs https://www.mpbio.com/eu/covid19-essential-products/rapidscript2021-05-10 13:04:00910Nucleic acid-PCRRT-PCR31 https://www.mpbio.com/media/productattachment/LS072020-EN-RapidScript-SARS-CoV-2-Assay-11MSTP400-Manual.pdf relative quantificationLOD2.5copies/μlPositive controlSARS-CoV-2 Nucleocapsid Markers (N1 and N2); RNase PThroughput400reactions645Rapid CRISPR-based tests for SARS-CoV-2 and other pathogens243Sherlock BiosciencesUnited Statessherlock.bio/NoCommercialisedNoNoNear POC / POCNucleic acid2021-05-10 13:04:00531Nucleic acid-OtherYesCRISPR333RainSure COVID-19 dPCR Detection Kit (lab-based)218RainSure Scientific Co., LtdChinawww.rainsurebio.com/NoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00280Nucleic acid-PCRRT-PCRType of antigenrecombinant SARS-CoV-2 antigens245RADI COVID-19 Detection Kit and RADI COVID-19 Triple Detection Kit150KH Medical Co. LtdSouth Koreawww.khmedical.co.kr/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00196Nucleic acid-PCRRT-PCRLOD1-10 copies/Rxn for S Gene, 10-50 copies/Rxn for RdRP GenePositive controlPositive control not specifiedAnalytical Sensitivity100%Analitical Specificity100%Throughput96samples599QuikPath Covid-19 POC molecular test362QuikPath Pte LtdSingaporewww.quikpath.sg/NoIn developmentNoNoLab-basedNucleic acid2021-05-10 13:04:00487Nucleic acid-PCRRT-PCR1438Quick SARS-CoV-2 Multiplex Kit672Zymo Research CorpUnited Stateswww.zymoresearch.comYesCommercialisedNoNoAutomatedManualNucleic acid2021-05-10 13:04:001190Nucleic acid-PCRRT-PCR113LOD10cprLOD167cpmPositive controla) CV Positive Control (external control sample; 2.5 cpu). b) Human RNase P (endogenous control)Negative controlNo Template Control (DNase/RNase-free water) to be extracted in parallel to clinical samplesAnalytical Sensitivity100Analitical Specificity100%Clinical Sensitivity100%Clinical Specificity100%Throughput96samples/run517Quick COVID-19 Realtime Multiplex PCR315Aura Biotechnologies LtdIndiawww.aurabiotech.com/NoIn developmentNoNoManualNucleic acid Additional info: https://www.frontiersin.org/articles/10.3389/fmed.2020.00225/full  2021-05-10 13:04:00417Nucleic acid-PCRRT-PCR516Quick COVID-19 Colorimetric LAMP PCR315Aura Biotechnologies LtdIndiawww.aurabiotech.com/NoIn developmentNoNoManualNucleic acid2021-05-10 13:04:00416Nucleic acid-PCRLAMP129quanty-CONV-1971ClonitItalywww.clonit.it/en/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:0090Nucleic acid-PCRRT-PCR http://newsletter.biozol.de/Mail/Bilder/Webseite/COVID-19%20Produkte/RT-25.5%20(ENG).pdfLOD1copies/μlPositive controlInhibition control, positive controls (synthetic RNA)Negative controlNot foundAnalitical SpecificityTested negative with samples tested as positive for other virusesClinical Sensitivity100%Clinical Specificity100%Throughputsingle tubes328QuantuMDx NAT for SARS-CoV-2214QuantuMDxUnited Kingdomwww.quantumdx.com/NoIn developmentNoNoManualNucleic acid2021-05-10 13:04:00275Nucleic acid-PCRRT-PCR716QuantiVirus SARS-CoV-2 test kit411DiaCartaUnited Statesdiacarta.com/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00565Nucleic acid-PCRRT-PCR120 https://diacarta.com/products/coronavirus-testAnalytical Sensitivity100copies/mlClinical Sensitivity96.7%Clinical Specificity100%Type of antigenSARS-CoV-2 antigen1404QuantiVirus SARS-CoV-2 Multiplex Test Kit411DiaCartaUnited Statesdiacarta.com/YesCommercialisedNoNoLab-basedNucleic acidNasopharyngeal swabOropharyngeal swabSputum2021-05-10 13:04:001167Nucleic acid-PCRNoRT-PCR120LOD50copies/mlAnalitical Specificity100%Clinical Sensitivity100%Clinical Specificity100%Throughput93%222Quantiplus CORONA Virus (2019nCoV) detection kit137Huwel Lifesciences Pvt. LtdIndiawww.huwellifesciences.in/NoIn developmentNoNoManualNucleic acid2021-05-10 13:04:00177Nucleic acid-PCRRT-PCR1401qSanger-COVID-19 Assay665BillionToOne, IncUnited Statesbilliontoone.com/NoCommercialisedNoNoLab-basedNucleic acidNasal swabNasopharyngeal swabOropharyngeal swab https://billiontoone.com/wp-content/uploads/2020/09/BillionToOne-IFU-1.pdf2021-05-10 13:04:001165Nucleic acid-PCRRT-PCR Website: upper respiratory swab specimens (such as nasal swab, mid-turbinateswab, nasopharyngeal swab, and oropharyngeal swab specimens); Sanger sequencing-based test for detection of SARS-CoV-2 RNALOD3200copies/mlAnalitical Specificity100%Clinical Sensitivity90%329QPOC Point of Care NAT for SARS-CoV-2214QuantuMDxUnited Kingdomwww.quantumdx.com/NoIn developmentNoNoLab-basedNucleic acid2021-05-10 13:04:00276Nucleic acid-PCRRT-PCR118Qplex COVID-19 RT-qLAMP Assay65CellSafeSouth Koreawww.cells-safe.com/NoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:0082Nucleic acid-PCRLAMP887qPCRbio Probe 1-step-go Kit491PCR BioSystemsUnited Kingdompcrbio.com/NoCommercialisedNoNoAutomatedManualNucleic acid2021-05-10 13:04:00699Nucleic acid-PCRRT-PCRType of antigenModified nucleocapsid protein (NCP)621qPCR SARS-CoV-2 (test description in spanish and english)272VitassaySpainvitassay.com/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00513Nucleic acid-PCRRT-PCR https://vitassay.com/wp-content/uploads/2020/04/IU_046-Ed03-Mar20-SARS-CoV-2.pdfLOD10copies of viral genome/μlCrossreactivitytested negative with 42 species of microorganisms470qMAXSen Coronavirus (SARS-CoV-2) RT-qPCR Detection Kit290Canvax BiotechSpaincanvaxbiotech.com/NoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00377Nucleic acid-PCRRT-PCR324QIAstat-Dx Respiratory Panel 2019-nCoV211QIAGEN GmbHGermanywww.qiagen.com/us/YesCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00272Nucleic acid-PCRRT-PCR https://corporate.qiagen.com/newsroom/press-releases/2020/20200226_coronavirusLOD40000copies/mlPositive controlyesNegative controlyesThroughputsingle tubes185qCOVID-19109Genomica SauSpaingenomica.com/YesCommercialisedNoNoManualNucleic acidvalidated at the National Center for Microbiology (Instituto de Salud Carlos III, Spanish National Reference Center) with a panel of 80 samples https://sonanano.com/wp-content/uploads/2020/09/Sona-Nanotech-COVID-19-LFA-Procedure-Card-PC-CV2-V00-04-sept-2020-2.pdf 2021-05-10 13:04:00143Nucleic acid-PCRRT-PCR90 http://genomica.com/covid-19/?lang=enPositive controlpositive control, not specifiedClinical Sensitivity100%Clinical Specificity98%Throughput48samples/runType of antigenspike protein antigen from SARS-CoV and SARS-CoV2932ProTect Covid-19 RT-qPCR kit509JN MedsysSingaporejnmedsys.com/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00733Nucleic acid-PCRRT-PCR90 https://jnmedsys.com/covid19/LOD10copies/reaction1376Promotor SARS-CoV-2 RT-PCR Test Kit565Acon Biotech (Hangzhou) Co., LtdChinawww.aconbio.com/YesCommercialisedNoNoLab-basedNucleic acidhttps://www.aconlabs.com.cn/en/MolecularDiagnosis/656.html https://www.aconlabs.com.cn/en/ACON/685.html2021-05-10 13:04:001140Nucleic acid-PCRRT-PCR90The Promotor SARS-CoV-2 RT-PCR Test Kit is a real-time reverse transcription polymerase chain reaction; (rRT-PCR) test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in oropharyngeal swab, nasopharyngeal swab and deep cough sputum specimens collected from individuals suspected of SARS-CoV-2 by their healthcare provider; triple target assay: high conserved regions within N, E, ORF1ab genesLOD500copies/mlPositive control1AUNegative control1AUAnalytical Sensitivity99.91%Analitical Specificity94.72%Accuracy97.93%Clinical Sensitivity97.46%Clinical Specificity98.26%Throughput96samples/run1799Promotor SARS-CoV-2 RT-PCR Test Kit683ACON Laboratories, IncUnited Stateswww.aconlabs.comYesCommercialisedNoNoMicroplateAutomatedNucleic acid2021-05-10 13:04:001478Nucleic acid-PCRRT-PCR90LOD500copies/mlPositive control1AUNegative control1AUAnalytical Sensitivity99.91%Analitical Specificity94.72%Clinical Sensitivity99.71%Clinical Specificity98.29%Throughput96%963PRESTO 2019-nCoV Direct qPCR Kit519AAZFrancewww.covid19aaz.com/en/covid-19-aaz-2/YesCommercialisedNoNoManualNucleic acidNot found Target ORF1ab; nucléocapside; https://www.oncology-and-cytogenetic-products.com/products/covid-19-detection-kit/; manufacturer webisute cannot be found at all. the info were extracted from an unzipped folder downloaded from the websited proposed by amalai2021-05-10 13:04:00757Nucleic acid-PCRRT-PCR45Analytical Sensitivity6copies/reaction246PowerChek 2019-nCoV Real-time PCR Kit151Kogene BiotechSouth Koreawww.kogene.co.kr/eng/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00197Nucleic acid-PCRRT-PCRPositive controlControl 1 (E gene)Control 2 (RdRp gene)Throughputsingle tubes180POCKIT Central SARS-CoV-2 (orf 1ab) Premix Reagent105GeneReach Biotechnology CorporationTaiwan ROCgenereach.com/NoCommercialisedNoNoLab-basedManualNucleic acid2021-05-10 13:04:00138Nucleic acid-PCRRT-PCR85LOD60000copies/mlPositive controlPositive control not specifiedAnalytical Sensitivity100%Analitical Specificity100%Clinical Sensitivity96.8%Clinical Specificity97.1%313PlexBio CoVid19/SARS/Influenza A, B Detection kit201PlexBio Co., LtdTaiwan ROCwww.plexbio.com/NoIn developmentNoNoManualNucleic acid2021-05-10 13:04:00258Nucleic acid-PCRRT-PCRType of antigenSARS-CoV-2971PhoenixDx SARS-Cov-2 IVD521Procomcure Biotech GmbHAustriashop.procomcure.com/YesCommercialisedNoNoNear POC / POCNucleic acid2021-05-10 13:04:00759Nucleic acid-PCRRT-PCR https://shop.procomcure.com/wp-content/uploads/2020/05/IFU-PhoenixDx-SARS-CoV-2-IVD_1.0.pdfLOD50copies/reactionPositive controlnon-infectious target positive controlNegative controlNegative human extraction control Clinical Sensitivity100%Clinical Specificity96.4%115Phantom 1.0 Dx (near POC)64Caspr BiotechUnited Statescaspr.bio/NoIn developmentNoNoNear POC / POCNucleic acid2021-05-10 13:04:0080Nucleic acid-PCRCRISPR311PerkinElmer SARS-CoV-2 Realtime RT-PCR Assay199PerkinElmer IncUnited Stateswww.perkinelmer.com/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00256Nucleic acid-PCRRT-PCR https://perkinelmer-appliedgenomics.com/home/products/sars-cov-2-real-time-rt-pcr-assay-ce-ivd/LOD20copies/ml20 copies/mlPositive controlyesNegative controlyesThroughputsingle tubes743PerkinElmer New Coronavirus Nucleic Acid Detection Kit199PerkinElmer IncUnited Stateswww.perkinelmer.com/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00602Nucleic acid-PCRRT-PCR https://perkinelmer-appliedgenomics.com/home/products/sars-cov-2-real-time-rt-pcr-assay-ce-ivd/LOD20copies/μlusing a 400 µL samplePositive controlORF1ab and N genes234PerfectQ COVID-19 Coronavirus Real Time PCR Kit145Jiangsu Bioperfectus Technologies Co. LtdChinawww.bioperfectus.comNoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00185Nucleic acid-PCRRT-PCR604PCR|COV365Scope Fluidics SAPolandscopefluidics.com/NoIn developmentNoNoLab-basedNucleic acid2021-05-10 13:04:00491Nucleic acid-PCRRT-PCR593PCLMD nCoV one step RT-PCR Kit202PCL IncSouth Koreawww.pclchip.com/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00482Nucleic acid-PCRRT-PCR105Clinical Sensitivity100%866PaxView COVID-19 real time RT-PCR197PaxGen Bio Co. LtdSouth Koreapaxgenbio.com/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00682Nucleic acid-PCRRT-PCR LOD100copies/reactionPositive controlRNAse P (RP)ThroughputSingle Tubes288PathoDetect CoVID-19 Detection Kit181Mylab Discovery Solutions Pvt. LtdIndiamylabdiscoverysolutions.com/NoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00238Nucleic acid-PCRRT-PCR217Panther Fusion SARS-CoV-2 assay133HologicUnited Stateswww.hologic.comNoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00173Nucleic acid-PCRRT-PCRhttps://www.hologic.com/package-inserts/diagnostic-products/panther-fusionr-sars-cov-2-assay20PANDAA qDx SARS-CoV-216Aldatu BiosciencesUnited Stateswww.aldatubio.com/NoIn developmentNoNoManualNucleic acid2021-05-10 13:04:0020Nucleic acid-PCRNoRT-PCRManual NAT 742Orig3n 2019 Novel Coronavirus (COVID-19) Test441Orig3nUnited Statesorig3n.com/NoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00600Nucleic acid-PCRRT-PCR1406OPTI SARS-CoV-2 RT-PCR Test668OPTI Medical SystemsUnited Stateswww.optimedical.comYesCommercialisedNoNoLab-basedNucleic acid https://www.optimedical.com/en/products-and-services/kits/opti-sars-cov-2-rt-pcr-test-kit/2021-05-10 13:04:001169Nucleic acid-PCRRT-PCR50 https://www.optimedical.com/files/art-06-57003-03-opti-sars-cov-2-rna-rt-pcr-test-ceivd-2.pdf;specimen: nasopharyngeal swabs, oropharyngeal swabs, bronchoalveolar lavage and sputum samples.LOD5copies/reactionPositive controlSARS-CoV-2 (N1 target region) and the internal control (RNase P)Negative controlPCR Grade WateAnalytical Sensitivity97%Analitical Specificity100%Clinical Sensitivity100%Clinical Specificity100%278One-step Direct Realtime PCR Test Kit of 2019-nCoV Coronavirus173MedStar Medical Co., LtdUnited Stateswww.medstarhealth.org/NoIn developmentNoNoManualNucleic acid2021-05-10 13:04:00229Nucleic acid-PCRRT-PCR218On-site rapid molecular diagnostic system based on Shenzhen Shineway Technology134Hong Kong University of Science and TechnologyHong Kong S.A.Rwww.ust.hk/news/research-and-innovation/www.ust.hkYesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00174Nucleic acid-PCRRT-PCR40 https://www.ust.hk/news/research-and-innovation/hkust-research-team-invents-worlds-fastest-coronavirus-detection266NxTAG CoV Extended Panel161Luminex Corp.United Stateswww.luminexcorp.com/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00213Nucleic acid-PCRRT-PCRSample preparation240 https://www.luminexcorp.com/covid19-testing-solutions/#molecularThroughput24samples/h1858Nucleic Acid Extraction or Purification Kit (Manual method)319Beijing Lepu Medical Technology Co., LtdChinaen.lepumedical.com/YesCommercialisedNoNoManualNucleic acidNO2021-05-10 13:18:201537OtherN.A.Extraction kit1154Nucleic Acid Detection Kit For COVID-19 (PCR Fluorescence Probe)604SINGUWAY BIOTECH IncChinawww.singuway.com/english/index.phpYesCommercialisedNoNoAutomatedManualNucleic acidAnterior nasal swabNasal swabOropharyngeal swabhttp://www.singuway.com/english/product_show.php?id=8552021-05-10 13:04:00929Nucleic acid-PCRRT-PCRPositive controlpseudovirus with target gene fragmentNegative controlcell culture medium1135NuActor - Viral extraction kit22Boditech Med IncSouth Koreawww.boditech.co.kr/eng/YesCommercialisedNoNoAutomatedManualNucleic acidExclusive Cartridge System; Magnetic bead method; Full Automated http://www.boditech.co.kr/eng/images/main/200703/Rev00_COVID-19_total_solution_brochure_20200701_s2.pdf; https://www.youtube.com/watch?v=3HLavwzytl02021-05-10 13:04:00918OtherOtherExtraction kit15283Novodiag COVID-19 + InfA/B177MobidiagUnited Kingdommobidiag.com/NoIn developmentNoNoLab-basedNucleic acid https://www.medrxiv.org/content/10.1101/2020.03.17.20037713v2.full.pdf 2021-05-10 13:04:00234Nucleic acid-PCRRT-PCR936Novodiag COVID-19177MobidiagUnited Kingdommobidiag.com/YesCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00736Nucleic acid-PCRRT-PCR60 https://mobidiag.com/products/coronavirus/#Novodiag-COVID-1951Novel Coronavivus(2019-nCov)Nucleic Acid Detection Kit-Multiple Fluorescence PCR33Bao Ruiyuan Biotech (Beijing) Co., LtdChinawww.bioreaource.com.cn/NoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:0038Nucleic acid-PCRRT-PCR1339Novel Coronavirus(SARS-CoV-2) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)649TBG BIOTECHNOLOGY XIAMEN IncChinawww.tbgxm.comYesCommercialisedNoNoAutomatedManualNucleic acid2021-05-10 13:04:001108Nucleic acid-PCRRT-PCRManual or automated Throughput96samples/run151Novel Coronavirus(2019-nCov)RT-PCR Kit86Dynamiker Biotechnology (Tianjin) Co., LtdChinaen.dynamiker.com/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00109Nucleic acid-PCRRT-PCR http://en.dynamiker.com/index/index/index.html299Novel Coronavirus test190NorthShore University HealthSystemUnited Stateswww.northshore.org/NoIn developmentNoNoLab-basedNucleic acid2021-05-10 13:04:00247Nucleic acid-PCRRT-PCR360Novel Coronavirus SARS-CoV-2 Nucleic Acid Detection Kit (Isothermal Amplification on Microfluidic Chip)238Shanghai Igenetec Diagnostics Co., LtdChinawww.igenetec.com/NoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00301Nucleic acid-PCRRT-PCR Accuracy92.8% IgGAccuracy96.5% IgMClinical Sensitivity82% IgMClinical Sensitivity93% IgGClinical Specificity96% IgMClinical Specificity97.5% IgG892Novel Coronavirus Real Time PCR Kit112Getein Biotech, IncChinaen.bio-gp.com.cn/YesCommercialisedNoNoAutomatedManualNucleic acid2021-05-10 13:04:00703Nucleic acid-PCRRT-PCRPositive controlRNA target gene100Novel Coronavirus COVID-1958BioReference LaboratoriesUnited Stateswww.bioreference.com/NoIn developmentNoNoLab-basedNucleic acid2021-05-10 13:04:0070Nucleic acid-PCRRT-PCR1971Novel Coronavirus 2019-nCOV Nucleic Acid Typing Test Kit (Real-Time PCR)863Wuhan HealthCare Biotechnology Co., Ltd.Chinawww.health-carebiotech.comYesCommercialisedNoNoNucleic acidBronchoalveolar lavage fluidNasopharyngeal swabOropharyngeal swabThis kit is used for the in vitro qualitative detection of suspected cases of pneumonia caused by New Coronavirus infection, patients with suspected clusters, other patients who need to be diagnosed or differentially diagnosed with the New Coronavirus infection, and nasopharyngeal swabs, oropharyngeal swabs, and bronchoalveolar lavage fluid samples of patients with mutation beads for the New Coronavirus ORF1ab and N gene, S gene N501Y mutation and S gene E484K mutation sites. for more information, please contact at cs@healthcare-bio.com2021-05-10 13:04:001647Nucleic acid-PCRRT-PCRMultipleNew Coronavirus ORF1ab and N gene, S gene N501Y mutation and S gene E484KLOD500cpmPositive control100%coincidence rate of positive controls is 100%.Negative control100%coincidence rate of negative controls is 100%.238Novel coronavirus 2019-nCoV nucleic acid detection kit (rRT- PCR method)146Jiangsu Microdiag Biomedicine Technology Co., LtdChinawww.microdiag.com/NoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00187Nucleic acid-PCRRT-PCR61Novel Coronavirus 2019-nCoV Nucleic Acid Detection Kit (Microfluidic Chip)37Beijing Bohui Innovation BiotechnologyChinawww.bohui-tech.com/YesCommercialisedNoNoChipLab-basedNucleic acidNasal swabThroat swabWe have CE marking, registered in Spanien.The products was registered in Spanish MOH with number RPS/1798/20202021-05-17 09:27:0243Nucleic acid-PCRRT-PCR359Novel Coronavirus 2019-nCoV Nucleic Acid Detection Kit (Fluorescent PCR Method)237Shanghai GeneoDx Biotechnology Co., LtdChinawww.geneodx.com/NoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00300Nucleic acid-PCRRT-PCR356Novel Coronavirus (SARS-CoV-2) Real Time Multiplex RT-PCR Kit User Manual235Shandong Shtars Biological Industry Co., LtdChinawww.shidasi.net/NoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00298Nucleic acid-PCRRT-PCRAccuracy97% IgGAccuracy93% IgM1486Novel Coronavirus (SARS-CoV-2) nucleic acid detection kit (Fluorescence PCR method)848Bioteke Taizhou Biotechnology Co., LtdChinawww.bioteke.cn/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:18:201238Nucleic acid-PCRRT-PCR50LOD500copies/mlPositive controlRNA pseudovirus containing target geneNegative controlRNase free H2OAnalytical Sensitivity95%Analitical Specificity99%Clinical Sensitivity95%Clinical Specificity98%Throughput48samples/run398Novel Coronavirus (SARS-CoV-2) nucleic acid detection kit (Digital PCR method)257TargetingOneChinawww.targetingone.com/NoCommercialisedNoNoManualNucleic acid https://www.testlinecd.com/file/1580/COVID-19_AN_NEW%20(002).pdf?version=202008131535 2021-05-10 13:04:00321Nucleic acid-PCRDigital-PCRType of antigennucleocapsid recombinant antigen (NP)546Novel Coronavirus (SARS-CoV-2) Nucleic Acid Assay Kit (RT-PCR)335ElabscienceUnited Stateswww.elabscience.com/NoCommercialisedNoNoAutomatedLab-basedNucleic acid2021-05-10 13:04:00444Nucleic acid-PCRRT-PCR355Novel coronavirus (COVID-19) nucleic acid detection kit (fluorescent PCR method)234Shaanxi Lifegen Co., LtdChinawww.lifegen.com/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00297Nucleic acid-PCRRT-PCRPositive controlPositive control not specifiedNegative controlNegative control not specified455283Zhuhai Haitai Biological Pharmaceutical Co., LTDChinawww.zhhaitai.com/en/index.aspNoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00368Nucleic acid-PCRRT-PCRType of antigennucleoprotein975Novel Coronavirus (2019-nCoV) RT-PCR Detection Kit236Shanghai Fosun Long March Medical Science Co., LtdChinaen.lm-diagnostics.com.cn/YesCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:18:20764Nucleic acid-PCRRT-PCRLOD1000copies/ml189Novel Coronavirus (2019-nCoV) Real-time RT-PCR Kit112Getein Biotech, IncChinaen.bio-gp.com.cn/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00147Nucleic acid-PCRRT-PCR http://en.bio-gp.com.cn/index.php/product/plist/10/69.html976Novel Coronavirus (2019-nCoV) Real-time Isothermal Amplification kit236Shanghai Fosun Long March Medical Science Co., LtdChinaen.lm-diagnostics.com.cn/YesCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:18:20765Nucleic acid-PCRRT-PCR120Positive controlInternal control, not specified144Novel Coronavirus (2019-nCoV) Real Time Multiplex RT-PCR kit80DAAN Gene Co., Ltd of Sun Yat-sen UniversityChinaen.daangene.com/YesCommercialisedNoNoManualNucleic acid The device is listed on the website but no info can be extracted2021-05-10 13:04:00100Nucleic acid-PCRRT-PCR226Novel Coronavirus (2019-nCoV) Nucleic Acid Test Kit (Multiple Fluorescence PCR)142Innovita Biological TechnologyChinawww.innovita.com.cn/NoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00182Nucleic acid-PCRRT-PCR342Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)223Sansure Biotech, IncChinawww.sansure.com.cn/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00285Nucleic acid-PCRRT-PCR http://111.0.93.182/eng.sansure.com.cn/data/upload/ueditor/20200331/5e82e2244cd59.pdfLOD200copies/mlPositive controlyesNegative controlyesAnalitical Specificitytested negative with more than 30 species of microorganismsThroughputsingle tubes1415Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit670Shanghai BioGerm Medical Biotechnology Co., LtdChinam.bio-germ.com/zt.php?class_id=102YesCommercialisedNoNoLab-basedNucleic acid http://m.bio-germ.com/zt.php?class_id=1022021-05-10 13:04:001176Nucleic acid-PCRRT-PCR90 Website: TARGETS: 2019-nCoV ORF1ab and N gene; Endogenous internal standard (RNP): RNase PLOD1000copies/mlThroughput50AU127New coronavirus nucleic acid assay69Chinese National Institute for Viral Disease Control and PreventionChinawww.chinacdc.cn/en/aboutus/orc_9362/201809/t20180926_194256.htmlNoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:0088Nucleic acid-PCRRT-PCR http://ivdc.chinacdc.cn/kyjz/202001/t20200121_211337.html215New Coronavirus COVID-19 Nucleic Acid Detection Kit (Fluorescent PCR Method)131Hangzhou Testsea Biotechnology Co., LtdChinawww.testsealabs.com/NoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00171Nucleic acid-PCRRT-PCR740NeuMoDx SARS-CoV-2 Assay440NeuMoDx MolecularUnited Stateswww.neumodx.com/NoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00599Nucleic acid-PCRRT-PCR657NeoPlex COVID-19 Detection Kit388GeneMatrix IncSouth Koreawww.genematrix.net/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00536Nucleic acid-PCRRT-PCR180 http://genematrix.net/2018/subpage.php?p=m1_2_neoplexCOVID19Positive controlPositive control not specifiedNegative controlNegative control not specifiedThroughputsingle tubes35nConV-19 Nucleic Acid qPCR Kit23Anlong GeneChinawww.anlongen.com/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:0029Nucleic acid-PCRNoRT-PCR https://www.anlongen.com/news/detail.html?id=55582MVC SARS-CoV-2 Real-Time PCR Diagnostic Kit352Medigen Vaccine Biologics Corp.Taiwan ROCwww.medigenvac.com/public/enYesCommercialisedNoNoManualNucleic acidDesigned according to WHO recommendations 2021-05-10 13:04:00471Nucleic acid-PCRRT-PCR90 https://covid19diag.com/our-products/Positive controlN gene plasmid and ORF1ab gene plasmidNegative controlNuclease-free distilled water581MVC SARS-CoV-2 Convective PCR Diagnostic Device/Kit352Medigen Vaccine Biologics Corp.Taiwan ROCwww.medigenvac.com/public/enNoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00470Nucleic acid-PCRRT-PCR1850MutaPLEX® CoV-2 MUT real time RT-PCR Kit845Immundiagnostik AGGermanywww.immundiagnostik.comYesCommercialisedNoNoOtherManualNucleic acidThe values for analytical and clinical sensitivity and specificity require strict adherence to the procedures described in the IFU. Test description The MutaPLEX® CoV-2 MUT real time RT-PCR Kit (Immundiagnostik AG, cat. No. KG193196) is an assay for the genotyping of SARS-CoV-2. There are 4 specific mutations in the spike protein, that can be detected by the real time RT-PCR: del69/70, del241-243, N501Y and H655Y. Combinations of the 4 different mutations are needed to identify the specific lineage of SARS-CoV-2. Lineage B.1.1.7 (UK variant): del69/70, N501Y Lineage B.1.351 (South Africa, ZA, variant): del241/243, N501Y Lineage P.1 (Brazil, BRA, variant): H655Y, N501Y2021-05-10 13:04:001530Nucleic acid-PCRYesRT-PCRQuantitative70LODOne copyPositive controlyes with 10,000 copies per PCRNegative controlyes, including internal controlAnalytical Sensitivity100%Analitical Specificity100%Clinical Sensitivity100%Clinical Specificity100%349Multitest230Selfdiagnostics Deutschland GmbHGermanyselfdiagnostics.comNoIn developmentNoNoLab-basedNucleic acid2021-05-10 13:04:00293Nucleic acid-PCRRT-PCR5734Beijing Applied Biological Technologies Co., LtdChinawww.x-abt.com/YesCommercialisedNoNoAutomatedLab-basedManualNucleic acid The device is listed on the website but no info can be extracted2021-05-10 13:04:0039Nucleic acid-PCRRT-PCR58Multiple Real-Time PCR Kit for Detection of 2019-nCoV35Beijing Beier Bioengineering Co., LtdChinawww.mediport.comNoIn developmentNoNoManualNucleic acid2021-05-10 13:04:0040Nucleic acid-PCRRT-PCR75Multiple Real-Time PCR kit for Detection of 2019-nCoV46Beijing NaGene Diagnosis Reagent Co., LtdChinawww.nagened.com/YesCommercialisedNoNoManualNucleic acid All info are available but no way to translate the image into EN2021-05-10 13:04:0053Nucleic acid-PCRRT-PCR http://www.nagened.com/product/278199690508MOLgen SARSCoV2 Real Time RT PCR304ADALTIS srlItalywww.adaltis.net/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00402Nucleic acid-PCRRT-PCR http://www.adaltis.net/products/molecular-diagnostic-tests/sars-cov2-covid-19/sars-cov2-covid-19/635MolecuTech Real-Time COVID-19377YD Diagnostics Corp.South Koreawww.yd-diagnostics.com/YesCommercialisedNoNoLab-basedNucleic acid This kit uses the principle of immuno-chromatography technology to detect the novel coronavirus (COVID-19) antigen in human saliva samples using the double antibody sandwich method. While testing, the sample contains the novel coronavirus (COVID-19) antigen and the concentration is higher than or equal to the minimum detection limit, the antigen reacts with the antibody to form a complex, and the novel coronavirus is coated in the detection area (T). The antibody is captured and a red reaction line is formed. The result is judged as positive; otherwise, the result without red line formed in T is judged as negative. Under normal testing conditions, the quality control area (C) should be colored to indicate that the test is valid. 2021-05-10 13:04:00522Nucleic acid-PCRRT-PCR http://www.yd-diagnostics.com/2012/eng/pdf/Covid/Insert_MolecuTech%20Real-Time%20COVID-19.pdfLOD10copies/reactionAnalitical Specificitytested negative with 75 species of microorganismsClinical Sensitivity100%Clinical Specificity100%Throughputsingle tubes1206Molecision SARS-CoV-2 RT-PCR Assay255Snibe Co., LtdChinawww.snibe.com/YesCommercialisedNoNoAutomatedManualNucleic acid https://drive.google.com/file/d/1CjDDY-GFr-xq4CELYS2ja_ts2B7shgit/view?usp=sharing2021-05-10 13:04:00991Nucleic acid-PCRRT-PCR https://drive.google.com/file/d/1CjDDY-GFr-xq4CELYS2ja_ts2B7shgit/view?usp=sharingPositive controlPseudo-Viruses of target virus gene and internal controlNegative controlNase-free waterClinical Specificity100%Type of antigennucleoprotein1492255Snibe Co., LtdChinawww.snibe.com/YesCommercialisedNoNoAutomatedManualNucleic acid2021-05-10 13:04:001242Nucleic acid-PCRRT-PCR90LOD120copies/mlPositive control97%Negative control100%Analytical Sensitivity97.4%Analitical Specificity100%Clinical Sensitivity97.4%Clinical Specificity100%531microproof SARS-CoV-2 Screening/Identification Kits325BIOTECON Diagnostics GmbHGermanywww.bc-diagnostics.com/YesCommercialisedNoNoAutomatedManualNucleic acid2021-05-10 13:04:00434Nucleic acid-PCRNoRT-PCR240 Information provided by the manufacturerLOD7.5cpr(5-10 cpr)Positive controlyesNegative controlyesThroughput96 samples per run580Microchip RT-PCR COVID-19 detection system350Lumex InstrumentsCanadawww.lumexinstruments.com/NoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00468Nucleic acid-PCRRT-PCR792Meril COVID-19 One-step RT-PCR Kit461Meril Diagnostics Pvt LtdIndiawww.merillife.com/medical-devices/diagnosticsYesCommercialisedNoNoAutomatedManualNucleic acid2021-05-10 13:04:00635Nucleic acid-PCRRT-PCR120 Information provided by the manufacturer: Meril COVID-19 One step RT-PCR Kit is intended for qualitative detection of nucleic acid from SARS-CoV-2 using real time PCR from Human nasal, nasopharyngeal, oropharyngeal swab specimens, and bronchoalveolar lavage samples. The results can be used to assist diagnosis of patients with COVID-19 infection. The Meril COVID-19 One step RT-PCR Kit is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. Summary and explanation of the test: The Meril COVID-19 One-step RT-PCR Kit is a qualitative test uses nucleic acid amplification technology and the standard hydrolysis probe system .The Human RNase P Internal Control is used to monitor the entire sample preparation and PCR amplification process. In addition, the test utilizes external controls (positive control and a negative control(DEPC-treated H2O).Principle:The primer and probe mix for this kit adopts the dual-target gene design, which targets the specific conserved sequence encoding the ORF 1ab gene and the nucleoprotein N gene. With the PCR reaction mix provided, the amplification of template can be quantitatively monitored by the increasing fluorescence signal detected by a real time PCR instrument.The PCR detection system includes an endogenous internal control primer and probe mix. The result of internal control provides the accuracy of sampling and extraction process, in order to avoid false negative results.Instrument Compatibility:This kit is compatible with real time PCR instruments with FAM, HEX/VIC, RED/ROX channels.LOD0.5cpu Positive controlPositive control is provided with the kit.Negative controlNo template control is provided with the kit. The test utilizes external controls (positive control and a negative control(DEPC-treated H2O)Analytical Sensitivity100Analitical Specificity100Clinical Sensitivity100Clinical Specificity100Throughput96samples/run1396MassARRAY SARS-CoV-2 Panel662AgenaBioscience,IncUnited Statesagenabio.comYesCommercialisedNoNoLab-basedNucleic acid reverse transcription (RT-PCR)/MALDI-TOF test; positive control: Twist Bioscience Synthetic SARS-CoV-2 RNA Control 1 #102019; extraction control: MS2 Phage RNA https://agenabio.com/products/panel/coronavirus-sars-cov-2-detection-panel/2021-05-10 13:04:001162Nucleic acid-PCRRT-PCR82 https://agenabio.com/wp-content/uploads/2020/11/MA_SC2_Panel_EUA_IFU-CUS-001_R06.pdfLOD2.5copies/μlPositive controlSynthetic SARS-CoV-2 RNA Control Negative controlNuclease-free waterClinical Sensitivity95%Clinical Specificity100%1417Macurra SARS-CoV-2 PCR Kit390Diazyme LaboratoriesUnited Stateswww.diazyme.com/NoCommercialisedNoNoLab-basedNucleic acid https://www.diazyme.com/images/covid19/5-eua200065-a001-maccura-sars-cov-2-fluorescent-pcr-kit-ifu.pdf2021-05-10 13:04:001178Nucleic acid-PCRRT-PCRMultiplexed assay primers/probes for ORF1ab, N, and E genesLOD1000copies/mlPositive controlMS2 based pseudo-virus containing ORF1ab, N, and E target gene fragments(5.0x103copies/mL)Negative controlDEPC-treated wateClinical Sensitivity100%Clinical Specificity96.7%232Machine-Free, Fast and Accurate Nucleic Acid Diagnoses System for COVID-19144IVDbio IncUnited Stateswww.ivdbiotechnology.com/NoIn developmentNoNoLab-basedNucleic acid2021-05-10 13:04:00184Nucleic acid-PCRRT-PCR17LyteStar 2019-nCoV RT-PCR Kit 1.013ADT BiotechMalaysiawww.adt-biotech.com/NoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:0017Nucleic acid-PCRRT-PCRManual NAT 331Lyra SARS-CoV-2 Assay216Quidel CorporationUnited Stateswww.quidel.com/YesCommercialisedNoNoManualNucleic acidAdditional info at https://www.quidel.com/sites/default/files/product/documents/PI_Lyra_SARS-CoV-2_04-06-20.pdf 2021-05-10 13:04:00278Nucleic acid-PCRRT-PCR75 https://www.quidel.com/molecular-diagnostics/lyra-sars-cov-2-assayPositive controlPositive Control #M5153. Process control. Negative controlNegative Control #M5031Analytical SensitivityEvaluatedAnalitical SpecificityEvaluatedThroughputsingle tubes1374Lucira COVID-19 All-In-One Test Kit656Lucira HealthUnited Stateswww.lucirahealth.comNoCommercialisedNoNoNear POC / POCNucleic acidNasal swab Lucira COVID-19 All-In-One Test Kit utilizes RT-LAMP technology to detect RNA of the N gene for SARS-CoV-2. 2021-05-10 13:04:001138Nucleic acid-PCRYesNoLAMPQualitative30LOD900copies/mlFp94%Fn98%1638Loopamp SARS-CoV-2 Detection kit734Eiken Chemical Co. LtdJapanwww.eiken.co.jpYesCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:001318Nucleic acid-PCRRT-PCR60 https://www.eiken.co.jp/en/products/lamp/covid19test/LOD100RNA-copiesPositive controlPositive Control 2019-nCoV (PC nCV19)Throughput48tubes130Logix Smart Coronavirus disease 2019 (COVID-19)72Co-diagnosticsUnited Statescodiagnostics.com/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:0091Nucleic acid-PCRRT-PCRLOD9.35copies/μlPositive controlpositive control, proprietary blend of positive primersNegative controlno template tubeAnalytical Sensitivity100%Analitical Specificity16 microorganisms in the cross-reactivity in silico assessmenttested negative with 16 species of microorganisms100% specificity with spiked samplesThroughputsingle tubes480LiliF COVID-19 Real-time RT-PCR Kit297iNtRON Biotechnology IncSouth Koreawww.intron.co.kr/YesIn developmentNoNoManualNucleic acidNasal swabNasopharyngeal swabOropharyngeal swabSputumCat.number is IPH215062021-05-17 11:27:43385Nucleic acid-PCRRT-PCRMultiplePurification test55LOD493copies/rxnfor the RdRP geneLOD493copies/rxnfor the E geneLOD49.3copies/rxnfor the N gene.Positive control100%Negative control100%Analytical Sensitivity100%Analitical Specificity100%Clinical Sensitivity100%Clinical Specificity100%824LightPower iVASARS-CoV-2 1st RT-rPCR Kit476RedcliffebioIndiawww.redcliffels.com/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00659Nucleic acid-PCRRT-PCR https://d5010ed6-7d13-4a4a-82f3-01f8c7e54506.filesusr.com/ugd/af67ea_4a38a3809a0d459692889d228b6abae3.pdfLOD5copies/reactionPositive controlRNAse P (RP)Analytical Sensitivity100%spiked samplesThroughputSingle tube410LightMix Modular SARS-CoV-2 (COVID19) RdRP-gene263TIB Molbiol/Roche DiagnosticsGermanywww.tib-molbiol.com/NoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00333Nucleic acid-PCRRT-PCR https://www.roche-as.es/lm_pdf/MDx_53-0776_96_Wuhan-E-gene_V200111_09155368001.pdf408LightMix Modular SARS-CoV-2 (COVID19) N-gene263TIB Molbiol/Roche DiagnosticsGermanywww.tib-molbiol.com/NoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00331Nucleic acid-PCRRT-PCR https://www.roche-as.es/lm_pdf/MDx_53-0775_96_Wuhan-N-gene_V200111_09155350001.pdf409LightMix Modular SARS-CoV-2 (COVID19) E-gene263TIB Molbiol/Roche DiagnosticsGermanywww.tib-molbiol.com/NoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00332Nucleic acid-PCRRT-PCR https://www.roche-as.es/lm_pdf/MDx_53-0777_96_Wuhan-R-gene_V200111_09155376001.pdf260Liferiver Novel Coronavirus (2019-nCoV) Real Time Multiplex RT-PCRT kit158LiferiverUnited Stateswww.liferiverbiotech.com/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00209Nucleic acid-PCRRT-PCR https://www.mobitec.com/media/liferiver/invitrodiagnostics/realtimepcrdiagnostickits/RR-0478-02-ZJ.pdfLOD1000copies/mlPositive controlyesNegative controlyesThroughputsingle tubes1825LAMPIGEN COVID19 RT-LAMP PCR KIT830Pharmaline ASTurkeypharmaline.com.tr/enYesCommercialisedNoNoStripManualNear POC / POCNucleic acidAnterior nasal swabNasal swabNasopharyngeal swabThroat swabINTENDED TO USE LAMPIGEN® RT-LAMP KIT is a screening assay with Fluorometric detection for SARS-CoV-2 viral RNA. A Point of Care diagnostic solution with Fluorometric RT-LAMP portable devices (Genie® II, III, and HT). LAMPIGEN® RT-LAMP KIT does not require RNA extraction and can be used directly on oropharyngeal/nasopharyngeal swab dilutions. The causative agent of COVID-19, SARS-CoV-2, is an enveloped, positive-sense RNA virus belonging to the Coronaviridae family. Regular and reliable detection of SARS-CoV-2 RNA is required to monitor the spread of the virus and screen clinical samples from patients displaying relevant symptoms of COVID-19. LAMPIGEN® RT-LAMP KIT is an in-Vitro diagnostic point of care test based on Reverse Transcription Loop-mediated isothermal AMPlification (RT-LAMP) technology for the detection of SARS-CoV-2 viral RNA. The detection is a one-step process, a closed-tube format where the reverse transcription and subsequent amplification of the specific target sequence occur in the same reaction well. The processing detects the amplified outcome in real-time using fluorescence exposure. It automatically runs an anneal curve at the end of amplification, where the reaction is heated to 98°C and slowly cooled. This final step acts as a secondary confirmatory check - ensuring LAMP amplicons are specific to SARS-CoV-2. The result is exact, and it reports automatically a positive (+) from both the amplification timeslot and the annealing temperature at which the test detects the virus2021-05-10 13:04:001502Nucleic acid-PCRYesLAMPFluorescence30Transcription Loop-mediated isothermal AMPlification (RT-LAMP) LOD3cpuPositive controlyesNegative controlyesAnalytical Sensitivity99%Analitical Specificity100%Clinical Sensitivity94%Clinical Specificity100%210LAMP kit for qualitative detection of SARS-CoV-2127Hangzhou Bigfish Bio-tech Co., LtdChinawww.bigfishgene.com/NoIn developmentNoNoManualNucleic acid2021-05-10 13:04:00166Nucleic acid-PCRLAMP223LAMP kit for qualitative detection of SARS-CoV-2138Institute of Chemical Biology and Fundamental MedicineRussiawww.niboch.nsc.ru/doku.php/enNoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00178Nucleic acid-PCRLAMP255LabCorp 2019 Novel Coronavirus test155Laboratory Corporation of AmericaUnited Stateswww.labcorp.com/NoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00206Nucleic acid-PCRRT-PCR512Kylt SARS-CoV-2 Screening RTU RT-qPCR309AniCon Labor GmbHGermanywww.kylt.euYesCommercialisedNoNoManualNucleic acidIncludes information about reproducibility and robustness 2021-05-10 13:04:00511Kylt SARS-CoV-2 Confirmation RT-Qpcr309AniCon Labor GmbHGermanywww.kylt.euYesCommercialisedNoNoManualNucleic acidIncludes information about reproducibility and robustness 2021-05-10 13:04:00408Nucleic acid-PCRNoRT-PCR https://www.kylt.eu/en/products/show/more/455LODPositive controlendogenous control (beta-Actin)Analitical Specificitytested negative with 21 species of microorganisms576KrosQuanT SARS-COV- 2 (2019 nCOV) Realtime PCR Kit345Krosgen BiotechTurkeywww.krosgen.comYesCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00462Nucleic acid-PCRNoRT-PCR90Throughputsingle tubes567KG virellaSARS-CoV-2 seqc real time RT-PCR Kit 2.0342Germanywww.gerbion.de/YesCommercialisedNoNoManualNucleic acidIncludes data on linearity and precision 2021-05-10 13:04:00456Nucleic acid-PCRRT-PCR http://www.gerbion.de/pdf/G01128.pdfLOD10copies/reactionAnalitical Specificitytested negative with 27 species of microorganismsThroughputsingle tubes832Kewei COVID-19 RT-PCR Test Kit43Beijing Kewei Clinical Diagnostic Reagent IncChinaen.keweidiagnostic.com/YesCommercialisedNoNoAutomatedManualNucleic acid2021-05-10 13:04:00663Nucleic acid-PCRRT-PCRFluorescence120Manual or automated Analytical Sensitivity93.3%Analitical Specificity100%794Kaira 2019-nCoV Detection kit894OPTOLANE Technologies, Inc.South Koreawww.optolane.com/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:18:20638Nucleic acid-PCRRT-PCR80 http://optolane.com/wp-content/uploads/2020/04/4-Kaira-2019-nCoV-Detection-kit-leaflet-0413-copy-Web-Version.pdfLOD1.38copies/μlfor E-geneLOD6.46copies/μlfor RdRPositive control E-gene, RdRP gene292Isothermal Exponential Amplification for COVID-19 Detection185NanoBio Lab, A*STAR Research EntitiesSingaporewww.a-star.edu.sg/nblNoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00242Nucleic acid-PCRRT-PCR934Isopollo COVID-19 detection Kit (real-time)510M monitor IncSouth Koreawww.mmonitor.net/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00734Nucleic acid-PCRRT-PCR20 http://www.mmonitor.net/eng/sub2/sub2_3.phpLOD1pgAnalitical Specificity100%1408IntelliPlex SARS-CoV-2 Detection Kit201PlexBio Co., LtdTaiwan ROCwww.plexbio.com/YesCommercialisedNoNoLab-basedNucleic acid https://www.plexbio.com/intelliplex%E2%84%A2-sars-cov-2-detection-kit2021-05-10 13:04:001171Nucleic acid-PCRRT-PCRThhis kit detects the presence of N, RdRp, and E genes of SARS-CoV-2 in RNA extracted from respiratory specimenLOD140copies/mlClinical Sensitivity100%Clinical Specificity100%Throughput564 samples/9h270164Mabsky Bio-Tech Co., LtdChinawww.mabsky.com/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00221Nucleic acid-PCRRT-PCR90 http://en.mabsky.com/en/new1/20200309/119.htmlLOD500copies/mlThroughputsingle tubes224InBios International Smart Detect SARS-CoV-2 rRT-PCR Kit139InBios InternationalUnited Statesinbios.com/NoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00179Nucleic acid-PCRRT-PCR1836iNADx Multiplex III COVID-19 RT-qPCR Kit838SACEM Hayat Teknolojileri A.S.Turkeywww.sacem.com.tr/YesCommercialisedNoNoMicroplateLab-basedManualNucleic acidNasal aspirationNasopharyngeal swabSputumThroat swabThe detection of SARS-CoV-2 RNA is done in single tube in which human RNase P is simultaneously detected. COVID-19 real-time PCR assay utilizes human RNase P as an internal control, which controls for target isolation and amplification. The oligonucleotide primers and probes for detection of SARS-CoV-2 were selected from regions of the virus conserved region of N gene. The kit is designed for specific detection of the SARS-CoV-2 (primer/probe sets).2021-05-10 13:04:001525Nucleic acid-PCRRT-PCRPositive controlRNase P1115Imegen SARS-CoV-2 plus460ImegenSpainwww.imegen.es/YesCommercialisedNoNoManualNucleic acidhttps://imegen.es/wp-content/uploads/2020/08/IMG-366-Instructions-for-use.pdf; nasal swab, nasopharyngeal swab, and oropharyngeal swab samples 2021-05-10 13:04:00897Nucleic acid-PCRRT-PCR80 https://imegen.es/inicio/kits-de-analisis/imegen-sars-cov-2-plus/LOD20copies/reactionPositive controlSpike glycoprotein gene (S); small envelope protein gene (E); the ORF1ab gene, and the GUS-B gene ( endogenous positive control a system that detects the human beta-glucuronidase gene).Negative controlNuclease-free waterAnalytical Sensitivity100%Analitical Specificity100%Throughput96samples/run789Imegen SARS-CoV-2460ImegenSpainwww.imegen.es/YesCommercialisedNoNoManualNucleic acidhttps://imegen.es/wp-content/uploads/2020/06/Quick_Guide_IMG-356-Imegen-SARS-CoV-2_English_Rev13.pdf; nasal swab, nasopharyngeal swab and oropharyngeal swab samples 2021-05-10 13:04:00634Nucleic acid-PCRRT-PCRN.A.N.A.80 https://imegen.es/inicio/kits-de-analisis/imegen-sars-cov-2/LOD10copies/reactionPositive controlORF1ab gene; spike glycoprotein gene (S); nucleocapsid protein gene (N); RNase P geneNegative controlNuclease-free waterAnalytical Sensitivity100%Analitical Specificity100%Throughput96%327Human COVID-19 (2-plex)213Quansys BiosciencesUnited Statesquansysbio.com/NoIn developmentNoNoAutomatedManualNucleic acid2021-05-10 13:04:00274Nucleic acid-PCRRT-PCR http://quansysbio.com/multiplex/multiplex-assays/human-covid-19-2-plex/216Hibergene (lab-based or near-POC)132HibergeneIrelandwww.hibergene.com/NoIn developmentNoNoLab-basedNucleic acid2021-05-10 13:04:00172Nucleic acid-PCRRT-PCRWHO-3714HDPCR SARS-CoV-2 real-time PCR assay70ChromaCodeUnited Stateschromacode.com/NoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00554Nucleic acid-PCRRT-PCR1230627Hayat Genetics IncTurkeywww.hayatgenetics.comYesCommercialisedNoNoAutomatedManualNucleic acid2021-05-10 13:04:001014Nucleic acid-OtherLAMP30LOD5cprPositive controlSynthetic SARS-CoV-2 DNANegative controlNuclease Free WaterAnalytical Sensitivity100%Analitical Specificity100%Clinical Sensitivity100%Clinical Specificity99%Throughput96 samples per run940GSD NovaPrime SARS-CoV- (COVID-19)368NovaTec Immundiagnostica GmbHGermanywww.novatec-id.com/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00745Nucleic acid-PCRRT-PCR120 https://www.goldstandarddiagnostics.com/home/products/covid-19-pcr-assay/gsd-novaprime-sars-cov-2-covid-19-real-time-pcr/gsd-novaprime-sars-cov-2-covid-19-real-time-pcr/Negative controlNuclease-free water723GS COVID-19 RT-PCR Kit431GenoSensorUnited Stateswww.genosensorcorp.com/NoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00588Nucleic acid-PCRRT-PCR896GPS 2019-nCoV qPCR kit499Genetic PCR SolutionsSpainwww.geneticpcr.com/index.php/en/NoCommercialisedNoNoAutomatedManualNucleic acid2021-05-10 13:04:00709Nucleic acid-PCRRT-PCR724Gnomegen COVID-19 RT-Digital PCR Detection Kit432GnomegenUnited Statesgnomegendx.com/NoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00590Nucleic acid-PCRDigital-PCR862Gmate Covid-19486Medisys International SA Gmate Covid-19South Koreawww.philosys.com/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00679Nucleic acid-PCRRT-PCR10Analytical Sensitivity93.4%Analitical Specificity97%2000Genomtec® SARS-CoV-2 EvaGreen® RT-LAMP CE-IVD Duo Kit919Genomtec SAPolandwww.genomtec.comYesCommercialisedNoNoMicroplateStripLab-basedManualNucleic acidNasal swabOropharyngeal swabSalivaThroat swabSpecificity of Genomtec® SARS-CoV-2 EvaGreen® RT-LAMP CE-IVD Duo Kit was confirmed in a study where assay mix (containing AmpMix and Detection Primers) was spiked with genetic material of 25 pathogens. None of the pathogens had any effect on RT-LAMP assay performance and cross-reacted. Genomtec® SARS-CoV-2 EvaGreen® RT-LAMP CE-IVD Duo Kit successfully detects all of the abovementioned SARS-CoV-2 variants: B.1.1.7; Breton (hCoV-19/France/BRE-IPP04233/2021); P1; B. 1.351; B.1.525; P.3 (version: 2021-04-01); B.1.427 (version: 2021-04-14); B.1.429. The Real-Time RT-PCR CE-IVD diagnostic kits (detecting at least two genes) were used as reference method for RT-LAMP assay and the protocol was compliant with the manufacturer’s instructions.2021-05-10 13:04:001677Nucleic acid-OtherYesLAMPQualitativeMultiple30LOD20cprPositive controlyes - synthetic SARS CoV-2 cDNANegative controlyes - DNase/RNase-Free Sterile WaterClinical Sensitivity100%Clinical Specificity100%7GenomEra SARS-CoV-25Abacus DiagnosticaFinlandwww.abacusdiagnostica.com/YesCommercialisedNoNoLab-basedNucleic acidRdRp and E genes GenomEra RUO SARS-CoV-2 test has a special approval in Finland (for research use in other countries)2021-05-10 13:04:007Nucleic acid-PCRRT-PCR70 https://www.abacusdiagnostica.com/products/sars-cov-2/916GenomeCoV9 Detection Kit504Applied Biological Materials IncCanadawww.abmgood.com/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00723Nucleic acid-PCRNoRT-PCR120LOD5copies/reactionPositive controlPositive control not specifiedNegative controlNegative control not specifiedClinical Sensitivity100%Clinical Specificity100%275GenoAmp Real-Time RT-PCR SARS-CoV-2171Medical Innovation Ventures Sdn Bhd.Malaysiamediven.com.my/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00227Nucleic acid-PCRRT-PCR150 http://mediven.com.my/index.php/catalog/genoamp-real-time-rt-pcr-sars-cov-2/Positive controlPositive and internal controlsThroughputsingle tubes1905Genespark SARS-CoV2 Quantitative detection of SARS-CoV2 genome806Immunospark s.r.l.Italywww.immunospark.comYesCommercialisedNoNoMicroplateAutomatedFully automated (robot)Semi-automatedNucleic acidBronchoalveolar lavage fluidDeep (cough) sputumNasal swabThroat swabQuantitative assay based on gene ORF1AB and N to applied on open systems2021-05-10 13:04:001581Nucleic acid-PCRYesRT-PCRQuantitativeMultipleOther120LOD200copies/mlAnalytical Sensitivity98%Analitical Specificity96%Clinical Sensitivity97%Clinical Specificity97%1156genesig(R) Coronavirus (COVID-19) Rt-PCR assay606Primerdesign, NovacytUnited Kingdomwww.primerdesign.co.ukYesCommercialisedNoNoManualNucleic acidNasopharyngeal swabOropharyngeal swabSalivaSputumA real-time PCR assay for the specific and exclusive detection of SARS-CoV-2 from human nasopharyngeal swabs, oropharyngeal swabs, sputum, raw saliva and preserved saliva specimens. Open platform chemistry with a range of validated instruments including the most abundant on the market. https://www.genesig.com/products/10039-coronavirus-covid-19-ce-ivd2021-05-10 13:04:00932Nucleic acid-PCRRT-PCR90LOD0.18cpuPositive controlSynthetic RNA, complimentary to ampliconNegative controlDNase/RNase free waterAnalytical Sensitivity100%Analitical Specificity100%Clinical Sensitivity100%Clinical Specificity100%Throughput96samples/run301genesig Real-Time PCR COVID-19192GenesigUnited Kingdomwww.genesig.com/YesCommercialisedNoNoManualNucleic acidIncludes data on reproducibility and repeatability 2021-05-10 13:04:00249Nucleic acid-PCRRT-PCR https://www.genesig.com/products/10039-coronavirus-covid-19-ce-ivd; https://www.genesig.com/assets/files/Path_COVID_19_CE_IVD_IFU_Issue_3.pdfLOD0.58copies/μlPositive controlyesNegative controlyesAnalytical Sensitivity95%Analitical Specificitytested negative with 10 species of microorganismsClinical Sensitivity98%Clinical Specificity100%Throughputsingle tubes1062GeneProof SARS-CoV-2 Screening PCR Kit507GeneProof a.s.Czechiawww.geneproof.com/en/YesCommercialisedNoNoManualNucleic acidinformation provided by producer information provided by the manufacturer / difference with data from pdf sensitivity 86.43 % and specificity 99.57 %; additional info consistency: reproducibility? 91.61 %) 2021-05-10 13:04:00843Nucleic acid-PCRRT-PCR1061GeneProof SARS-CoV-2 PCR Kit507GeneProof a.s.Czechiawww.geneproof.com/en/YesCommercialisedNoNoManualNucleic acidinformation provided by producer 2021-05-10 13:04:00842Nucleic acid-PCRRT-PCR928GeneProof SARS-CoV- Screening PCR Kit507GeneProof a.s.Czechiawww.geneproof.com/en/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00731Nucleic acid-PCRRT-PCRLOD200copies/mlPositive controlPositive control not specifiedNegative controlNegative control not specifiedAnalitical Specificity100%927GeneProof SARS-CoV- PCR Kit507GeneProof a.s.Czechiawww.geneproof.com/en/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00730Nucleic acid-PCRRT-PCRLOD65.44copies/μlPositive controlPositive control not specifiedNegative controlNegative control not specifiedAnalitical Specificity100%172GenePro SARS-CoV-2 Test98Gencurix IncSouth Koreawww.gencurix.comYesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00130Nucleic acid-PCRRT-PCR90LOD77copies/rxnPositive controlPositive control not specifiedAnalytical Sensitivity100%Analitical Specificity100%Throughput96 or 384 reactions171GenePro COVID-19 Detection Test98Gencurix IncSouth Koreawww.gencurix.comYesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00129Nucleic acid-PCRRT-PCR90LOD1copies/μlPositive controlPositive control: virus RNAThroughputSingle tubes178geneOmbio COVID-19 rt-LAMP test103geneOmbio Technologies Pvt. LtdIndiawww.geneombiotechnologies.com/NoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00135Nucleic acid-PCRLAMP1221geneMAP Respiratory Viral PCR Panel 2 (2019-nCoV, Inf A/B, RSV A/B)571Genmark Saglik UrunleriTurkeywww.genmark.com.trYesCommercialisedNoNoAutomatedManualNucleic acid Conformity 95.09% 2021-05-10 13:04:001004Nucleic acid-PCR46LOD500copies/mlPositive controlSynthetic Nucleic Acid (Ultramer)Negative controlRNase Free WaterAnalytical Sensitivity95%Analitical Specificity96%Clinical Sensitivity95%Clinical Specificity96%Throughput96samples/run samples per run1059geneMAP 2019-nCoV (SARS-CoV-2) Rapid Detection Kit571Genmark Saglik UrunleriTurkeywww.genmark.com.trYesCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00838Nucleic acid-PCRNoRT-PCR75LOD1000cpmPositive controlSynthetic Nucleic Acid (Ultramer)Negative controlV (Virus Transport Medium)Analytical Sensitivity98%Analitical Specificity100%Clinical Sensitivity96%Clinical Specificity98%Throughput96samples/run1222geneMAP 2019-nCoV (SARS-CoV-2) Detection Kit571Genmark Saglik UrunleriTurkeywww.genmark.com.trYesCommercialisedNoNoAutomatedManualNucleic acid https://onlinelibrary.wiley.com/doi/full/10.1002/jmv.25727 2021-05-10 13:04:001006Nucleic acid-PCRRT-PCR46manual or automated LOD200copies/mlPositive controlSynthetic Nucleic Acid (Ultramer)Negative controlRNase Free WaterAnalytical Sensitivity95%Analitical Specificity98%Clinical Sensitivity95%Clinical Specificity98%Throughput96 samples per run304GeneFinder COVID-19 RealAmp Kit702OSANG Healthcare Co., LtdSouth Koreawww.osanghc.com/YesCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:18:20252Nucleic acid-PCRRT-PCR180 https://www.elitechgroup.com/genefinder-covid-19-realamp-kit889GeneFinder COVID-19 Plus RealAmp Kit852ELITechGroupFrancewww.elitechgroup.comYesCommercialisedNoNoAutomatedManualNucleic acid2021-05-10 13:18:20701Nucleic acid-PCRRT-PCR180 https://www.elitechgroup.com/genefinder-covid-19-realamp-kit1591GeneFinder COVID-19 Fast RealAmp Kit702OSANG Healthcare Co., LtdSouth Koreawww.osanghc.com/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:001271Nucleic acid-PCRLAMP60Manual NAT LOD2cpmThroughput96 samples per run174Genedrive 96 SARS-CoV-2 Kit100Genedrive plcUnited Kingdomwww.genedrive.com/NoIn developmentNoNoAutomatedLab-basedNucleic acid2021-05-10 13:04:00132Nucleic acid-PCRRT-PCR 925Genedrive 96 SARS-CoV- Kit100Genedrive plcUnited Kingdomwww.genedrive.com/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00728Nucleic acid-PCRRT-PCR100LOD0.5copies/μlAnalytical Sensitivity100%Analitical Specificity98.2%Throughput96 reactions1142GENEDIA W COVID-19 Real Time RT-PCR kit600Green Cross Medical Science Corp.South Koreawww.greencrossms.com/eng/main.do?lang=ENYesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00919Nucleic acid-PCRRT-PCR Information provided by the manufacturer: "GENEDIA W COVID-19 Real-Time RT-PCR Kit is an in vitro diagnostic (IVD) real-time reverse transcriptase polymerase chain reaction (RTPCR) test for detection SARS-CoV-2 virus gene(RdRP, E, N and S gene) from specimens of human respiratory organs(Nasopharyngeal, Oropharyngeal swab, Sputum, Bronchoalveolar lavage)."Clinical Sensitivity100%Clinical Specificity100%Type of antigenRdRP, E, N and S gene1143GENEDIA W COVID-19 Colorimetric LAMP premix kit600Green Cross Medical Science Corp.South Koreawww.greencrossms.com/eng/main.do?lang=ENYesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00920Nucleic acid-OtherLAMP32 Information provided by the manufacturer: GENEDIA W COVID-19 Colorimetric LAMP premix kit is an in vitro diagnostic reagent kit for qualitative analysis to detect SARS-CoV-2 infection from extracted RNA of clinical specimens of smeared material from human nasopharyngeal and oropharyngeal swab, sputum and bronchoalveolar lavage of patients suspected SARS-CoV-2 by RT-LAMP (Reverse Transcription loop-mediated isothermal amplification) used together with Isothermal amplification Instrument or PCR Instrument.LOD100cpuClinical Sensitivity100%Clinical Specificity100%173Gene Bio COVID-19 Qualitative Real Time PCR Kit Ver. 1.099Gene BiosystemsEgyptwww.gene-biosystems.com/NoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00131Nucleic acid-PCRRT-PCR1046GB SARS-CoV-2 Real-Time RT-PCR(E gene/ORF1ab)104General Biologicals CorporationTaiwan ROCwww.gbc.com.tw/YesCommercialisedNoNoManualNucleic acidTargets: E gene and ORF1ab region of SARS-CoV-2 (COVID-19) 2021-05-10 13:04:00818Nucleic acid-PCRRT-PCR LOD510copies/ml(5×102 copies/ml)851GB SARS-CoV-2 Real-Time RT-PCR (E/N/ORF1ab)104General Biologicals CorporationTaiwan ROCwww.gbc.com.tw/YesCommercialisedNoNoManualNucleic acidTarget: E gene, N gene and ORF1ab region of SARS-CoV-2 (COVID-19) 2021-05-10 13:04:00673Nucleic acid-PCRRT-PCRLOD102copies/ml(1×102 copies/ml)1587GB SARS-CoV-2 Real-Time RT-PCR104General Biologicals CorporationTaiwan ROCwww.gbc.com.tw/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:001267Nucleic acid-PCRRT-PCR60LOD100cpmPositive controlSARS-CoV-2 PC, non-infectious RNA moleculeNegative controlNegative control (H2O)Analytical Sensitivity100%Analitical Specificity100%Clinical Sensitivity100%Clinical Specificity100%179GB SARS-CoV-2 Real Time RT-PCR104General Biologicals CorporationTaiwan ROCwww.gbc.com.tw/NoIn developmentNoNoManualNucleic acid2021-05-10 13:04:00136Nucleic acid-PCRRT-PCR556gb SARS-CoV-2 RdRP (confirmation test)339Generi Biotech s.r.o.Czechiawww.generi-biotech.comYesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00449Nucleic acid-PCRRT-PCRPositive controlPositive control not specifiedNegative controlNuclease-free waterThroughputsingle tubes785gb SARS-CoV-2 N (confirmation test)339Generi Biotech s.r.o.Czechiawww.generi-biotech.comYesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00632Nucleic acid-PCRRT-PCRLOD4copies/reactionPositive controlPostive control not specifiedNegative controlNegative control not specified555gb Sarbeco N (primary test)339Generi Biotech s.r.o.Czechiawww.generi-biotech.comYesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00448Nucleic acid-PCRRT-PCRLOD3copies/reactionPositive controlPositive control not specifiedNegative controlNuclease-free waterThroughputsingle tubes784gb Sarbeco E (primary test)339Generi Biotech s.r.o.Czechiawww.generi-biotech.comYesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00631Nucleic acid-PCRRT-PCRLOD3copies/reactionPositive controlPostive control not specifiedNegative controlNegative control not specified1171GA-map COVID-19 Fecal Test615Genetic Analysis ASNetherlandswww.genetic-analysis.com/YesCommercialisedNoNoAutomatedManualNucleic acidStoolGA-map COVID-19 Fecal Test, a Qualitative Real-Time PCR test for the detection of the 2019 novel coronavirus (SARS-CoV-2) RNA in stool samples. Features:• The Test has been developed from and validated with, human stool samples from confirmed COVID-19 positive patients (nasopharyngeal positive test results) and, stool samples from known COVID-19 negative patients. • SARS-CoV-2 target genes and controls were selected in accordance with the US Centers for Disease Control and Prevention (CDC) information for molecular detection of SARS-CoV-2. • The GA-map COVID-19 Fecal Test has been specifically developed and validated for stool specimens. • The test is CE-marked and In-vitro Diagnostic (IVD) Use for stool samples.• Results available after 5 hoursProduct description:The CE-marked GA-map COVID-19 Fecal Test is designed to qualitatively detect SARS-CoV-2 in faecal samples. Viral ribonucleic acid (RNA) is isolated from human faecal samples followed by selective amplification of the target gene using specific primers for two sequences within the SARS-CoV-2 Nucleocapsid gene (N1 and N2). RNA detection probes labeled with a fluorescent dye act as a reporter. Each probe also has a second dye which acts as a quencher. When not bound to the target sequence, the fluorescent signals of the intact probes are suppressed by the quencher dye. The real-time data is recorded in a real-time (RT)-PCR instrument and the results are reported as either positive or negative based on cycle threshold (Ct) recordings.Benefits:• Detect gastrointestinal COVID-19 infection• Non-invasive and Easy self-sampling sample collection• Highly specific RT- PCR test for the identification of SARS-CoV-2 in faeces• Fast and accurate detection of SARS-CoV-2 RNA presence in stool over an extended period compared to the few days’ detection window from nasopharyngeal samples using robust RT-PCR technique.• Internal Control, Human RNaseP (RP) gene amplified with dedicated primers for every sample• May help with confirmation of Covid-19 clearance and management of social distancing/return to work policiesApplicable to:• patients exhibiting signs and symptoms of COVID-19 (confirmation and management)• patients in the recovery phase (surveillance and clearance)• asymptomatic individuals concerned about possessing and transmitting the virus (prevention)• Screening faecal microbiota transplant (FMT) donors http://www.genetic-analysis.com/new-covid-192021-05-10 13:04:00952Nucleic acid-PCRNoRT-PCR300 Information provided by the manufacturerLOD14copies/μlPositive controlGA-map COVID-19 Positive Control + intern control (Human RNaseP (RP) gene)Negative controlGA-map dH2OAnalytical Sensitivity99.8%Analitical Specificity100%Throughput96 samples per run1897Fully Automated Nucleic Acid Extractor865Yantai Addcare Bio-Tech Limited CompanyChinawww.addcare.cn/en/NoNoNoFully automated (robot)Nucleic acid2021-05-10 13:04:0060Fully Automated 26 Plex RES Panel Assay37Beijing Bohui Innovation BiotechnologyChinawww.bohui-tech.com/NoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:0042Nucleic acid-PCRRT-PCR16392Fast Track DiagnosticsLuxembourgwww.fast-trackdiagnostics.com/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00118Nucleic acid-PCRRT-PCR http://www.fast-trackdiagnostics.com/human-line/products/ftd-sars-cov-2/Positive controlORF1ab / N gene1856Freeze-dried Novel Coronavirus (COVID-19) nucleic acid detection kit （Fluorescence PCR method）848Bioteke Taizhou Biotechnology Co., LtdChinawww.bioteke.cn/YesCommercialisedNoNoMicroplateMicrotiter plateManualNucleic acidNasal aspirationNasal swabOropharyngeal swabhttps://www.bioteke.cn/2021-05-10 13:04:001536Nucleic acid-PCRYesRT-PCRQuantitativeFluorescence50LOD500cprPositive controlRNA pseudovirus containing target geneNegative controlRNase free waterAnalytical Sensitivity95%Analitical Specificity99%Clinical Sensitivity95%Clinical Specificity98%720Fosun COVID-19 RT-PCR Detection Kit236Shanghai Fosun Long March Medical Science Co., LtdChinaen.lm-diagnostics.com.cn/NoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:18:20586Nucleic acid-PCRRT-PCR1447FOAMING TEST674PharmaNonaTurkeywww.foamingtest.comYesCommercialisedNoNoNear POC / POCNucleic acid2021-05-10 13:04:001197Nucleic acid-OtherYesOtherOther1Positive control89AUNegative control92AUAnalytical Sensitivity92%Analitical Specificity92%Clinical Sensitivity92%Clinical Specificity92%Throughputsingle tubes167Fluxergy Sample-to-Answer SARS-CoV-2 RT-PCR96Fluxergy LLCUnited Statesfluxergy.com/humanNoIn developmentNoNoLab-basedNucleic acid2021-05-10 13:04:00126Nucleic acid-PCRRT-PCR274FLUOROSEARCH Novel Coronavirus (SARS-CoV-2) Detection Kit170Japanwww.mblbio.comNoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00226Nucleic acid-PCRRT-PCR https://www.mblbio.com/bio/g/info/news/2020/SARS-CoV-2.html1721Fluorion nCoV-19 QLP 2.1 Real-Time PCR Kit764IontekTurkeywww.iontek.com.tr/YesCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:18:201401Nucleic acid-PCRRT-PCR60http://www.iontek.com.tr/wp-content/uploads/2021/01/iontekkatalog2021.pdfLOD10cprPositive controlN1 and N2 regions of nucleocapsid gene of SARS-CoV-2 virus and Human RNaseP gene (internal control)Analytical Sensitivity95%Analitical Specificity100%Clinical Sensitivity100%Clinical Specificity100%Throughputsingle tubes239Fluorescent RAA Detection for 2019-nCoV148Jiangsu Qitian Gene Biotechnology Co., LtdChinaqt.test.xjrkj.com/NoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00191Nucleic acid-PCRRT-PCR119FastRT-qPCR COVID19 detection kit65CellSafeSouth Koreawww.cells-safe.com/NoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:0083Nucleic acid-PCRRT-PCR747Fast Track Diagnostics (FTD) SARS-CoV-2 Assay444Siemens HealthineersGermanywww.siemens-healthineers.comYesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00604Nucleic acid-PCRRT-PCR180 https://www.siemens-healthineers.com/press-room/press-releases/test-kit-for-coronavirus-covid-19-ce-ivd.htmlClinical Sensitivity100CI95%: 91.8-100Clinical Specificity100CI95%: 93.8-100483Fast SARS-CoV-2 NAT with CRISPR assay by digital microfluidics automation298MGI Tech Co., LtdChinaen.mgitech.cn/NoCommercialisedNoNoLab-basedNear POC / POCNucleic acid2021-05-10 13:04:00387Nucleic acid-OtherCRISPR542FAST RT-PCR KIT, Real time PCR kit for COVID19 detection333DNA Xperts Pvt LtdIndiadnaxperts.com/NoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00442Nucleic acid-PCRRT-PCR2053FAGO MEDİKAL945FAGO MEDİKAL SANAYİ TİCARET LTD. ŞTİ.Turkeywww.famexmask.comYesCommercialisedNoNoFingertipLateral flowNear POC / POCNucleic acidNasal swabNasopharyngeal swabSalivaWhole bloodthe form is submitted according to three types of tests.2021-05-11 09:39:291731Nucleic acid-PCRYesImmunochromatographyQualitativeMultipleSample collection device15LOD100TCID50/mlAnalytical Sensitivity97.7%Analitical Specificity98%Clinical Sensitivity97.7%Clinical Specificity98%334Extended Coronavirus Array219Randox Laboratories LtdUnited Kingdomwww.randox.com/coronavirus-randox/NoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00281Nucleic acid-PCRRT-PCRType of antigenrecombinant SARS-CoV-2 antigens1335ExProbe SARS-CoV-2 Testing Kit406TBG Biotechnology Corp.Australiawww.tbgbio.com/enYesCommercialisedNoNoManualNucleic acidNasopharyngeal swabSputum2021-05-10 13:04:001104Nucleic acid-PCRRT-PCR80 http://www.tbgbio.com/files/instruction_manuals/1.5%20IFU_COVID19_qPCR_CE_v1.5.pdfLOD50copies/reactionPositive controlVirus-like Particles(VLPs) containing target sequence for each target gene(RdRP,E, N)and internal standard gene fragments (RNase P)Negative controlVirus-like Particles(VLPs)containing internal standard gene fragments (RNase P)Type of antigenRdRP, N and E genes of SARS-CoV-22065EXPERT COVID-19 VRT KIT 2-RQ953EXPERTEAM SRLItalywww.experteam.itYesCommercialisedNoNoMicroplateManualNucleic acidNasal swabNasopharyngeal swabOropharyngeal swabcon questo kit è possibile analizzare da 1 a 96 campioni a seduta2021-05-17 10:44:241745Nucleic acid-PCRRT-PCRQualitative80Positive controlpresente2064EXPERT COVID-19 KIT 1-RQ953EXPERTEAM SRLItalywww.experteam.itYesCommercialisedNoNoMicroplateManualNucleic acidNasal swabNasopharyngeal swabOropharyngeal swabIl kit permette l'analisi da 1 a 96 campioni per corsa2021-05-17 10:41:311744Nucleic acid-PCRRT-PCRQualitative80LOD25copies/μlPositive controlpresente1738EXON SARS-CoV-2 Real Time PCR Tanı Kiti​772EXON BIYOMEDIKALTurkeywww.exonbiyomedikal.comYesCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:001416Nucleic acid-PCRRT-PCR46 https://www.exonbiyomedikal.com/wp-content/uploads/2020/12/EXON-SARS-CoV-2-Real-Time-PCR-Detection-Kit-Users-Manual.pdfLOD1cpuPositive controlPlasmid including N1, Orf1ab and Human RNAsePNegative controlNuclease Free WaterAnalytical Sensitivity100%Analitical Specificity100%Clinical Sensitivity99%Clinical Specificity99%Throughputsingle tubes1450ExAmplex Influenza A/B SARS-CoV-2 PCR kit22Boditech Med IncSouth Koreawww.boditech.co.kr/eng/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:001200Nucleic acid-PCRRT-PCR95Manual NAT LOD6.79copies/reactionPositive controlN gene sequence of SARS-CoV-2Negative controlNuclease-free waterAnalytical Sensitivity100%Analitical Specificity100%Clinical Sensitivity100%Clinical Specificity100%Throughputother104ExAmplar COVID-19 real-time PCR kit (L)22Boditech Med IncSouth Koreawww.boditech.co.kr/eng/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:0074Nucleic acid-PCRRT-PCR159EURORealTime SARS-CoV-290EUROIMMUN AGGermanywww.coronavirus-diagnostics.com/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00115Nucleic acid-PCRRT-PCR https://www.coronavirus-diagnostics.com/documents/Indications/Infections/Coronavirus/MP_2606_D_UK_A.pdfPositive controlInternal control, not specifiedAnalytical Sensitivity100%Analitical Specificity100%473EurobioPlex SARS-CoV-2 Multiplex294Eurobio ScientificFrancewww.eurobio-scientific.com/YesCommercialisedNoNoManualNucleic acid the kit exists on the website but no info can be extracted2021-05-10 13:04:00382Nucleic acid-PCRRT-PCR https://www.eurobio-scientific.com/848EuDx COVID-19 Detection Kit483Eudipia Co., LtdSouth Koreawww.eudipia.com/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00670Nucleic acid-PCRRT-PCR http://www.eudipia.com/184ePlex SARS-CoV-2 Test108GenMark DiagnosticsUnited Stateswww.genmarkdx.comNoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00142Nucleic acid-PCRRT-PCR1183ender MASS618Ender diagnostics agSwitzerlandwww.enderdiagnostics.comYesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00965Nucleic acid-PCRRT-PCR45Isothermal AmplificationLOD60000copies/mlPositive controlinternal amplification controlNegative controldH2OClinical Sensitivity93%Clinical Specificity100%Throughput96samples/run1184ender LAB618Ender diagnostics agSwitzerlandwww.enderdiagnostics.comYesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00966Nucleic acid-PCRRT-PCR46Isothermal AmplificationLOD25000copies/mlPositive controlinternal amplification controlNegative controldH2OClinical Sensitivity97.7%Clinical Specificity100%Throughput96samples/runType of antigenSARS-CoV-2847EliGene COVID19 CONFIRM RT336Elisabeth Pharmacon spol. s.r.o.Czechiawww.elisabeth.czYesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00668Nucleic acid-PCRRT-PCR https://www.elisabeth.cz/en/product-eligene-covid19-confirm-rt.htmlPositive controlPositive control not specifiedNegative controlWaterClinical Sensitivity100%Clinical Specificity100%846EliGene COVID19 BASIC A500 RT336Elisabeth Pharmacon spol. s.r.o.Czechiawww.elisabeth.czYesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00667Nucleic acid-PCRRT-PCR https://www.elisabeth.cz/en/product-eligene-covid19-basic-a-rt.htmlPositive controlPositive control not specifiedNegative controlWaterClinical Sensitivity100%Clinical Specificity100%548EliGene COVID19 BASIC A RT336Elisabeth Pharmacon spol. s.r.o.Czechiawww.elisabeth.czYesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00445Nucleic acid-PCRRT-PCR https://www.elisabeth.cz/en/product-eligene-covid19-basic-a-rt.htmlLOD15copies/sampleClinical Sensitivity100%Clinical Specificity100%513311AnyGenesFrancewww.anygenes.com/NoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00411Nucleic acid-PCRRT-PCR182EasyScreen Pan-Coronavirus/SARS-CoV-2 Detection Kit107Genetic Signatures LimitedAustraliageneticsignatures.com/NoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00141Nucleic acid-PCRRT-PCR418EasyNAT Integrated, Automated Molecular Diagnostic Assay for COVID-19 RNA860Ustar Biotechnologies (Hangzhou) LtdChinaen.bioustar.comNoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:18:20341Nucleic acid-PCRRT-PCRAccuracy92.08%((196+118)/(217+124)) (95%CI: 88.69% -94.72%) Clinical Sensitivity90.32% (196/217) (95% CI: 85.59%-93.91%).Clinical Specificity95.16% (118/124) (95% CI: 89.77%-98.20%)1045EasyCOV560Sys2diagFrancewww.sys2diag.cnrs.fr/NoCommercialisedNoNoManualNucleic acidSaliva Data provided by the Manufacturer; https://www.skillcell-alcen.com/sites/skillcell-alcen/files/pdf/press/Clinical-assessment-of-EasyCov-v10_1.pdf https://www.testlinecd.com/file/1580/COVID-19_AN_NEW%20(002).pdf?version=202008131535 information provided by the manufacturer; https://www.skillcell-alcen.com/products-licensing/easycov-covid-19-salivary-rapid-molecular-test2021-05-10 13:04:00816Nucleic acid-OtherRT-PCR60 https://www.skillcell-alcen.com/sites/skillcell-alcen/files/pdf/EasyCOV-process-EN.pdfPositive controlpositive saliva sampleNegative controlNegative saliva sampleAnalytical Sensitivity72.7%Analitical Specificity95.7%Throughput1 single tubeType of antigennucleocapsid recombinant antigen843Easy SARS-CoV-2479Diatech PharmacogeneticsItalywww.diatechpharmacogenetics.com/en/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00664Nucleic acid-PCRRT-PCR http://sklep.genos.com.pl/zalaczniki/zalacznik1911.pdfLOD5copies/reactionPositive controlPositive control not specifiedNegative controlWaterClinical Sensitivity100%Clinical Specificity100%Throughput96samples/run306Dr. PCR COVID-19 Viral Load 20K197PaxGen Bio Co. LtdSouth Koreapaxgenbio.com/NoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00254Nucleic acid-PCRRT-PCR303Dr. PCR COVID-19 Viral Load 20K894OPTOLANE Technologies, Inc.South Koreawww.optolane.com/NoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:18:20251Nucleic acid-PCRRT-PCR1714Direct RT-qPCR SARS-CoV-2762Redcell BiyoteknolojiTurkeyen.redcell.com.tr/YesCommercialisedNoNoAutomatedManualNucleic acid2021-05-10 13:04:001394Nucleic acid-PCRRT-PCR80 Test Kit for Detecting SARS-CoV-2 is a real-time reversetranscription polymerase chain reaction (rRT-PCR) test.The oligonucleotide primers and probes for specific detection of SARS-CoV-2 are selectedfrom regions of Open Reading Frame 1ab (ORF1ab) and the nucleocapsid gene (N) ofthe SARS-CoV-2 genome. https://en.redcell.com.tr/covid-19LOD500cpmPositive controlSynthetic SARS-CoV-2 genome fragmentNegative controlSynthetic SARS-CoV-2 genome fragmentDEPC-treated moleculer grade waterAnalytical Sensitivity97.63%Analitical Specificity100%Clinical Sensitivity96.92%Clinical Specificity100%Throughput96samples/run376DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit246Solgent Co., LtdSouth Koreawww.solgent.comYesCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00309Nucleic acid-PCRRT-PCR120 http://www.solgent.com/english/sub03020102/view/id/45LOD10copies/reactionPositive controlyesNegative controlyesAnalitical Specificitytested negative with 38 species of microorganismsThroughputsingle tubes457Diagnostic Kit for Nucleic Acid to nCoV-2019 (PCR- Fluorescence Probe)225Zhuhai Livzon Diagnostics IncChinawww.livzondiagnostics.com/en-us/list/39.htmlNoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00369Nucleic acid-PCRRT-PCR1194Diagnostic Automation, Inc. SARS-CoV-2 RT-PCR Kit582Diagnostic Automation/Cortez Diagnostics, IncUnited Stateswww.rapidtest.comYesCommercialisedNoNoAutomatedManualNucleic acid2021-05-10 13:18:20979Nucleic acid-PCRRT-PCR3 target-system minimizes potential for reduced detection of new SARS-CoV-2 variantsMultiplex format allows for single-well detection of 3 different targets. Compatible with multiple PCR instruments after proper validationCompatible with multiple RNA extraction kits after proper validation.LODClinical Sensitivity100%Clinical Specificity96.7%Throughput48samples/runType of antigenSARS-CoV-2 viral nucleoprotein antigens.295DiaCarta's QuantiVirusTMSARS-CoV-2 Test186Next Pharma IncCanadanextpharmainc.com/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00243Nucleic acid-PCRRT-PCR120 http://nextpharmainc.com/Clinical Sensitivity96.7%Clinical Specificity100%1122Dia-CV19-3 SARS-CoV-2 Direct OneStep RT-PCR Kit (S-/ORF1ab-Gene)331Diagen Biotechnologic Systems IncTurkeywww.diagen.com.tr/YesCommercialisedNoNoManualNucleic acidhttp://diagen.com.tr/assets/uploads/other/files/Covid/Dia-CV19-3_Direct_S-ORF1ab-Gene__v01_EN_100.pdf http://diagen.com.tr/assets/uploads/other/files/Covid/Diagen_COVID-19_Diagnostic_Products_3plex_EN_12.07.2020.pdf2021-05-10 13:04:00905Nucleic acid-PCRRT-PCR52 Website: the kit includes the extraction step from the samples (10 minutes)Positive controlS-gene + ORF1ab-gene + internal control (GAPDH gene)Negative controlNuclease-free waterThroughput100AU540Dia-CV19-2 SARS-CoV-2 OneStep RT-PCR Kit (S-/ORF1ab-Gene)331Diagen Biotechnologic Systems IncTurkeywww.diagen.com.tr/YesCommercialisedNoNoManualNucleic acidhttp://diagen.com.tr/assets/uploads/other/files/Covid/Dia-CV19-2_OneStep__S-ORF1ab-Gene__v01_EN_100.pdf http://diagen.com.tr/en/products/human-diagnostic-products/molecular-products/covid-192021-05-10 13:04:00440Nucleic acid-PCRRT-PCR52 There is NO isolation step in the kit, it works with isolated RNA.; http://diagen.com.tr/en/products/human-diagnostic-products/molecular-products/covid-19#gallery-2Positive controlS-gene + ORF1ab-gene + internal control (GAPDH gene)Negative controlNuclease-free waterThroughput100AU1121Dia-CV19-1 SARS-CoV-2 OneStep RT-PCR Kit (S-Gene)331Diagen Biotechnologic Systems IncTurkeywww.diagen.com.tr/YesCommercialisedNoNoManualNucleic acidhttp://diagen.com.tr/assets/uploads/other/files/Covid/Dia-CV19-1_OneStep__S-Gene__v01_EN_100.pdf http://diagen.com.tr/assets/uploads/other/files/Covid/Diagen_COVID-19_Diagnostic_Products_3plex_EN_12.07.2020.pdf2021-05-10 13:04:00904Nucleic acid-PCRRT-PCR52 http://diagen.com.tr/en/products/human-diagnostic-products/molecular-products/covid-19#gallery-4Positive controlS-gene + internal control (GAPDH gene)Negative controlNuclease-free waterThroughput100AU237Detection of 2019 novel coronavirus (2019-nCoV) by LFD RT-RAA146Jiangsu Microdiag Biomedicine Technology Co., LtdChinawww.microdiag.com/NoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00186Nucleic acid-PCRRT-PCR782Detection Kit for the SARS-CoV-2 RNA Presence in Biological Material Using Real-Time (RUO)458EMGRussiaevotech-mg.com/enNoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00630Nucleic acid-PCRRT-PCR722Detection Kit for Novel Coronavirus (SARS-CoV-2) RNA (PCR-Fluorescence Probing)430GenetronChinawww.genetronhealth.com/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00587Nucleic acid-PCRRT-PCR194Detection Kit for 2019-nCoV RNA (RT-PCR Fluorescence Probing) (Lyophilised)115Guangdong Huayin Medicine Science Co.,. LtdChinawww.dnb.com/business-directory/company-profiles.guangzhou_huaying_medicine_co_ltd.bcabedffc9a7841d04458552deccec04.htmlNoIn developmentNoNoManualNucleic acid2021-05-10 13:04:00150Nucleic acid-PCRRT-PCR33Detection Kit for 2019-nCov nucleic acid (Fluorescence PCR)23Anlong GeneChinawww.anlongen.com/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:0027Nucleic acid-PCRNoN.A.RT-PCRfluorescence detectionLOD200copies/ml200 copies/ml (ORF1ab gene) and 300 copies/ml (N gene)Positive controlpositive control, not specifiedNegative controlNegative control not specifiedAnalitical SpecificityNot foundThroughputSingle tubes514Detection Kit for 2019 Novel Coronavirus (2019-nCoV) RNA (PCR-Fluorescence Probing)312Appolon BioteckFranceappolonbioteck.fr/YesCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00412Nucleic acid-PCRNoRT-PCRLOD500copies/mlAnalitical Specificityno cross-reaction with other pathogensThroughputsingle tubes536Curative-Korva SARS-Cov-2 Assay330Curative Inc (in conjunction with KorvaLabs, Inc)United Stateswww.curativeinc.com/NoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00439Nucleic acid-PCRRT-PCR1119COVIDsure Pro Multiplex RT PCR Kit19Trivitron Healthcare Pvt. LtdIndiawww.trivitron.com/YesCommercialisedNoNoManualNucleic acid samples from entire respiratory tract http://www.absology.co.kr/ https://www.trivitron.com/products/covid-19/covid-19-testing-kits/covidsure-pro-multiplex-rt-pcr-kit2021-05-10 13:04:00900Nucleic acid-PCRRT-PCR60 https://www.trivitron.com/uploads/brochure/15946436444COVIDsure_Pro_eBrochure_13072020.pdfLOD5copies/μlPositive controlORF 1ab, envelope (E), and nucleocapsid (N) + internal controlAnalytical Sensitivity100%Analitical Specificity100%Type of antigennucleoprotein625COVIDsure Multiplex Realtime RT-PCR Kit19Trivitron Healthcare Pvt. LtdIndiawww.trivitron.com/YesCommercialisedNoNoManualNucleic acidBronchoalveolar lavage fluidNasopharyngeal swabOropharyngeal swabhttps://www.trivitron.com/products/covid-19/covid-19-testing-kits/covidsure-multiplex-realtime-rt-pcr-kit 2021-05-10 13:04:00515Nucleic acid-PCRRT-PCR90 https://www.trivitron.com/uploads/brochure/15954874997COVIDsure_Brochure_23072020.pdfPositive controlnCoV ORF1ab, E and Human RPP30Throughput100reactions/kit1160COVID19 TaqMan RT-PCR Kit Dx (E-RdRP genes) (DxTM67200)189Norgen Biotek Corp.Canadanorgenbiotek.com/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00941Nucleic acid-PCRRT-PCR45 Information provided by the manufacturer: COVID-19 TaqMan RT-PCR Kit (E/RdRP genes) Dx kit is a multiplexed assay designed for simple, reliable and rapid qualitative detection of SARS-CoV-2 specific RNA using TaqMan technology (FAM and HEX/VIC). The kit includes 2x One-Step RT-PCR Master Mix and 2 primer/probe mixes, a positive control and a negative control (nuclease-free water). The first primer/probe mix is the E gene/RP that targets the SARS-CoV-2 – specific Envelop gene (E gene - FAM) in addition to the human RNase P transcript (RP - HEX/VIC) as an internal control target to monitor for PCR inhibition, and to validate the quality of the sample and the detection result. The second Primer/Probe Mix is for the RdRP gene and detects two RNA-dependent RNA Polymerase (RdRP) targets where the first RdRP target is SARS-CoV-2 specific (FAM) while the second RdRP target is to detect SARS-CoV and bat-SARS-related CoVs (HEX). The use of the second RdRP gene Primer/Probe Mix is only required as a discriminatory/confirmatory step with samples showing positive amplification of the E gene. The provided E gene/RdRP/RP Positive Control contains an in vitro RNA transcript for the three SARS-related target genes: E gene, RdRP gene as well as the human RP (internal control).LOD10virus-copiesPositive controlThe positive control contains the SARS-CoV-2 E gene, RdRP gene and RNase P RNA fragmentsNegative controlNuclease-free waterAnalytical Sensitivity100%Analitical Specificity100%Throughput96samples/run271COVID-19 virus (2019-nCOV) Triple-Detection Kit (Real-Time PCR Method)164Mabsky Bio-Tech Co., LtdChinawww.mabsky.com/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00222Nucleic acid-PCRRT-PCR90 http://en.mabsky.com/en/new1/20200309/119.htmlLOD500copies/mlThroughputsingle tubes269COVID-19 virus (2019-nCoV) Dual-Detection Kit164Mabsky Bio-Tech Co., LtdChinawww.mabsky.com/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00217Nucleic acid-PCRRT-PCR90 http://en.mabsky.com/en/new1/20200309/119.htmlLOD500copies/mlThroughputsingle tubes416COVID-19 test268UPMCUnited Stateswww.upmc.com/aboutNoIn developmentNoNoLab-basedNucleic acid2021-05-10 13:04:00339Nucleic acid-PCRRT-PCR1407COVID-19 RT-qPCR Test669Phosphorus DiagnosticsUnited Stateswww.phosphorus.comNoCommercialisedNoNoManualNucleic acidSaliva https://www.phosphorus.com/covid-19-rt-qpcr-test2021-05-10 13:04:001170Nucleic acid-PCRN.A.RT-PCRtested in Phosphorus company laboratories1153COVID-19 RT-PCR PNA KIT603TNS Co., Ltd (BioTNS)South Koreawww.biotns.co.krYesCommercialisedNoNoManualNucleic acid14 days from symptom onset to blood collectionMade in Taiwan https://drive.google.com/file/d/1vJgzeTNjDYsYbbxzvo8N2rNj1vcRhJq6/view]]>2021-05-10 13:04:00928Nucleic acid-PCRRT-PCR140 information provided by the manufacturer + website: SPECIMENS: nasopharyngeal swab samples. Possibly Oropharyngeal swabs, anterior nasal swabs, mid-turbinate nasal swabs, bronchoalveolar lavage (BAL), and nasopharyngeal, wash/aspirates or nasal aspirates; CROSSREACTIVITY checked against: Human coronavirus 229E, Human coronavirus OC43, Human coronavirus NL63, Adenovirus subtype B, Adenovirus subtype C, Human Metapneumovirus (hMPV), Human parainfluenza 1, Human parainfluenza 2, Human parainfluenza 3, Human parainfluenza 4, Influenza A, Influenza B, Human Respiratory syncytial virus A, Human Respiratory syncytial virus B, Rhinovirus A, Rhinovirus B, Bordetella pertussis, Mycoplasma pneumoniae; INTERNAL CONTROL: primer set and probe to detect a specific region of Human acidic ribosomal protein (HuPO) gene. LOD2.5copies/μlRdRP geneLOD3.7copies/μlN genePositive controlartificially synthesized RNA of SARS-CoV-2 RdRP and N genes + short regions from the human acidic ribosomalprotein (HuPO) geneNegative controlNuclease Free waterAnalytical Sensitivity100%Analitical Specificity100%Clinical Sensitivity100%Clinical Specificity100%Throughput96samples/run155COVID-19 Real-time PCR Testing Kit88Edinburgh Genetics LimitedUnited Kingdomeggenetics.com/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00112Nucleic acid-PCRRT-PCR https://img1.wsimg.com/blobby/go/0bb0cb4f-fcc3-4a80-a429-81e323b73197/downloads/COVID-19%20Real-time%20PCR%20Testing%20Kit%20%20v2.0%20.pdf?ver=1586095524802Positive controlendogenous internal control detection systemPositive control: pseudovirus containing target sequencesNegative controlNegative control: pseudovirus with internal control fragmentsAnalytical Sensitivity100%Coincidence rate 100% with 5 positive references and 12 negative referencesAnalitical Specificity100%tested negative with 16 species of microorganismsClinical SpecificityCoincidence rate 100% with 5 positive references and 12 negative referencesThroughputsingle tubesType of antigenSARS-CoV-2 antigen809COVID-19 Real Time PCR Kit470Turkeywww.snp.com.tr/EN,28/news.htmlNoCommercialisedNoNoManualNucleic acid https://www.eternal-group.com/FileUpload/ProductEN/N5X8T4GNMH_COVIDual.pdf 2021-05-10 13:04:00651Nucleic acid-PCRRT-PCR http://www.snp.com.tr/Eklenti/1047LOD10copies/rxnPositive controlPositive control not specifiedNegative controlNegative control not specifiedAnalytical Sensitivity100%Analitical Specificity100%Clinical Sensitivity100%Clinical Specificity100%Type of antigenrecombinant N protein antigen (nucleoprotein)165COVID-19 Rapid Home Nucleic Acid Test93FemtoDxUnited Statesfemtodx.com/NoIn developmentNoNoLab-basedNucleic acid2021-05-10 13:04:00123Nucleic acid-PCRRT-PCR550Covid-19 qRT PCR Detection Kit643Eryigit Biomedical DevicesTurkeywww.eryigit.com.trYesCommercialisedNoNoManualNucleic acid2021-05-10 13:18:20446Nucleic acid-PCRRT-PCR15 https://www.eryigit.com.tr/en/coronavirus-detection-kit-2/Positive controlPositive control not specifiedNegative controlNuclease-free water897COVID-19 qPCR kit500MesloCypruswww.meslo.com/YesCommercialisedNoNoAutomatedManualNucleic acid2021-05-10 13:04:00710Nucleic acid-PCRRT-PCR120 https://www.meslo.com/category/704/Coronavirus-qPCR-test-Kits--and--Rapid-Kits-COVID-19.htmlLOD100copies/reaction414COVID-19 PCR, on WHO protocol266University of North Carolina Medical Center McLendon Clinical LaboratoriesUnited Stateswww.uncmedicalcenter.org/mclendon-clinical-laboratories/NoIn developmentNoNoLab-basedNucleic acid2021-05-10 13:04:00336Nucleic acid-PCRRT-PCR148COVID-19 PCR DIATHEVA Detection kit85Diatheva SRLItalywww.diatheva.comYesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00108Nucleic acid-PCRRT-PCRWHO-5 https://www.diatheva.com/images/DATASHEET/MBK_MBR/MBK0091%20COVID-19%20Pcr%20Diatheva%20Detection%20Kit.pdfPositive controlRNase P target as internal positive controlpositive control sampleNegative controlno template tubeClinical Sensitivity100%Clinical Specificity100%Throughputsingle tubes442COVID-19 ORF1ab/N Gene PCR Detection Kit279Xi'an Tianlong Science and Technology Co., LtdChinawww.medtl.com/NoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00354Nucleic acid-PCRRT-PCRType of antigennucleoprotein595COVID-19 One-Step COVID-19 RT-PCR Kit358Pishtaz Teb DiagnosticsIranwww.pishtazteb.com/enYesCommercialisedNoNoAutomatedManualNucleic acid2021-05-10 13:04:00483Nucleic acid-PCRRT-PCR100 http://pishtazteb.com/en/wp-content/uploads/2020/06/PCR-Covid-19.25.Apr_.2020.pdfLOD200copies/mlPositive controlPositive control not specifiedNegative controlNegative control not specifiedAnalitical Specificity100%326COVID-19 Nucleic Acid Detection Kit (Rapid PCR Fluorescence Method)212NavidChinawww.naidesw.com/newsdetail/18.htmlNoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00273Nucleic acid-PCRRT-PCR443COVID-19 Nucleic Acid Detection Kit (Multiplex Real Time PCR)280Yaneng BIOscience (Shenzhen) Co., LtdChinawww.yanengbio.com/NoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00356Nucleic acid-PCRRT-PCRType of antigennucleoprotein598COVID-19 Multiplex Fluorescent PCR Kit361Qingdao Funuo Biomedical Co., LtdChinawww.funuomed.com/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00486Nucleic acid-PCRRT-PCR http://www.funuomed.com/productsLOD20copies/ml382COVID-19 Multiplex Crystal Digital PCR detection kit251STILLAUnited Stateswww.stillatechnologies.comNoIn developmentNoNoManualNucleic acid2021-05-10 13:04:00314Nucleic acid-PCRDigital-PCR961COVID-19 mouth and throat Swab517Luxus Lebenswelt GMBH (Beijing NaGene Diagnosis Reagent Co., Ltd)Chinawww.nagened.com/YesCommercialisedNoNoManualNucleic acidIn Italy and Germany is distributed by Luxus Lebenswelt GMBH (AMP)2021-05-10 13:04:00755Nucleic acid-PCRRT-PCR http://www.nagened.com/product/278199690Type of antigenN protein1052COVID-19 Lyophilised Nucleic Acid Kit561AMS UK (NI) LtdUnited Kingdomwww.amslabs.co.ukYesCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00823Nucleic acid-PCRNoRT-PCR60LOD300cpmClinical Sensitivity100%Clinical Specificity100%Throughput48samples/run1075COVID-19 Lyophilised Nucleic Acid Kit575Prestige DiagnosticsUnited Kingdomwww.prestigediagnostics.co.ukYesCommercialisedNoNoLab-basedNucleic acid Information provided by the manufacturer: qualitative assay; human respiratory tract secreation sample; Sensitivity limit: 500copies/ml; coincidence rate of Positive reference: 98%; Coincidence rate ofNegativereference: 100%; Precision: CV% ?5%. https://f95fa0e3-ef79-4e7f-a6df-88d8f019025a.filesusr.com/ugd/ca8cd1_d64bc7a5da794aa5be81bcc37b468717.pdf2021-05-10 13:04:00853Nucleic acid-PCRRT-PCR https://f95fa0e3-ef79-4e7f-a6df-88d8f019025a.filesusr.com/ugd/ca8cd1_d64bc7a5da794aa5be81bcc37b468717.pdfLOD500cpmPositive controlSARS-CoV-2 ORF1ab and Nucleoprotein geneNegative controlRNase-free and nuclease-free distilled waterThroughput48samples/run737COVID-19 Key438MicroGenDxUnited Stateswww.microgendx.com/NoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00597Nucleic acid-PCRRT-PCR91COVID-19 Go Strips54BiomemeUnited Statesshop.biomeme.comNoCommercialisedNoNoStripLab-basedNucleic acid2021-05-10 13:04:0063Nucleic acid-PCRRT-PCRPositive percet agreement (PPA): 93.53; Negative percet agreement (NPA): 97.5; Total percet agreement (NPA): 95 1157CoVID-19 dtec-RT-qPCR-Test499Genetic PCR SolutionsSpainwww.geneticpcr.com/index.php/en/YesCommercialisedNoNoManualNucleic acid https://www.geneticpcr.com/en/about-us/ce-mark/cedeclaration2021-05-10 14:12:58939Nucleic acid-PCRRT-PCRManual NAT 1207CoVID-19 dtec-RT-qPCR Test499Genetic PCR SolutionsSpainwww.geneticpcr.com/index.php/en/YesCommercialisedNoNoManualNucleic acid https://www.geneticpcr.com/index.php/en/pathogen-r-d-qpcr/covid-19-rna 2021-05-10 13:18:20992Nucleic acid-PCRRT-PCR58 https://www.geneticpcr.com/index.php/en/pathogen-r-d-qpcr/covid-19-rna LOD10 copiesPositive controlStandard template includedNegative controlDNase/RNase free water includedAnalytical Sensitivity100%for 10 copiesAnalitical SpecificityAnalytical specificity: Tested inclusivity SARS-CoV-2 and exclusivity SARS-CoVClinical Sensitivity100%Clinical Specificity100%Throughputsingle tubes, strips or plates755COVID-19 Droplet Digital PCR (ddPCR) Assay57BioRadUnited Stateswww.bio-rad.com/NoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00610Nucleic acid-PCRDigital-PCR https://www.medrxiv.org/content/10.1101/2020.02.29.20029439v2962COVID-19 Coronavirus Real Time PCR Kit518Bioperfectus Technologies Co. Ltd (Jiangsu)Chinawww.bioperfectus.comYesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00756Nucleic acid-PCRRT-PCR72 http://en.s-sbio.com/product/420.htmlLOD350copies/mlPositive controlGenes of RNaseP891COVID-19 CE IVD qPCR assay493AssayGenieIrelandwww.assaygenie.comYesCommercialisedNoNoAutomatedManualNucleic acid2021-05-10 13:04:00702Nucleic acid-PCRNoRT-PCR https://www.assaygenie.com/2019-novel-coronavirus-2019-ncov-triplex-rt-qpcr-detection-kit/LOD200copies/mlPositive controlRNA pseudovirus containing target geneNegative controlDEPC-Treated WaterAnalytical Sensitivity100%Analitical Specificity100%146COVID-19 Assay83Diagnostic Solutions LaboratoryUnited Stateswww.diagnosticsolutionslab.com/NoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00106Nucleic acid-PCRRT-PCR166COVID-1995Fulgent Genetics/MedScan LaboratoryUnited Stateswww.fulgentgenetics.com/NoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00125Nucleic acid-OtherRT-PCR702COVID-19394ARUP LaboratoriesUnited Stateswww.aruplab.com/NoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00542Nucleic acid-PCRRT-PCR436Covflu-SR, Coronavirus 2019-nCoV and influenza virus A/B nucleic acid detection275Wuxi Shenrui Bio-pharmaceuticals Co. LtdChinawww.sr-bio.com/YesCommercialisedNoNoManualNucleic acid EN not avaialable at all2021-05-10 13:04:00349Nucleic acid-PCRRT-PCR http://www.sr-bio.com/728COV-19 IDx assay435Ipsum DiagnosticsUnited Stateswww.ipsumdiagnostics.com/NoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00593Nucleic acid-PCRRT-PCR421Coronavirus SARS-CoV-2 RT-PCR assay271Viracor EurofinsUnited Stateswww.viracor-eurofins.com/clinical-diagnostics/NoIn developmentNoNoLab-basedNucleic acid2021-05-10 13:04:00343Nucleic acid-PCRRT-PCRType of antigen2019-nCoV nucleocapsid protein antigen2051Coronavirus Disease 2019 Real Time PCR Kit944MedicalSystem Biotechnology Co. Ltd.Chinahttps://en.nbmedicalsystem.com/en/YesCommercialisedNoNoMicroplateLab-basedNucleic acidBronchoalveolar lavage fluidOropharyngeal swab2021-05-10 13:04:001729Nucleic acid-PCRNoRT-PCRQualitativeOther120target RNALOD500AUCalibrationEvaluatedCrossreactivityEvaluatedFp0%Fn0%PrecisionEvaluatedAccuracy99.25%ReproducibilityEvaluatedRobustnessEvaluatedClinical Specificity100%330Coronavirus Disease 2019 (COVID-19) Test215Quest DiagnosticsUnited Stateswww.questdiagnostics.com/home/NoIn developmentNoNoLab-basedNucleic acid2021-05-10 13:04:00277Nucleic acid-PCRRT-PCR479Coronavirus Disease 2019 (COVID-19) Nucleic Acid Testing Kit (CAMP-based)296Institute of Process Engineering, Chinese Academy of SciencesChinawww.ipe.cas.cn/NoIn developmentNoNoManualNucleic acid2021-05-10 13:04:00384Nucleic acid-PCRRT-PCR967Corona Virus Disease 2019 (CoViD-19) Nucleic Acid Detection Kit520OACP S.R.L.Irelandwww.oncology-and-cytogenetic-products.com/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00758Nucleic acid-PCRRT-PCR110 https://www.oncology-and-cytogenetic-products.com/products/covid-19-detection-kit/LOD500copies/mlClinical Sensitivity100%Clinical Specificity99%435Corona Virus Disease 2019 (COVID-19) Nucleic Acid Detection Kit863Wuhan HealthCare Biotechnology Co., Ltd.Chinawww.health-carebiotech.comYesCommercialisedNoNoManualNucleic acid2021-05-10 13:18:20348Nucleic acid-PCRRT-PCR110 https://www.health-carebiotech.com/product-descriptions/corona-virus-disease-2019-covid-19-nucleic.htmlLOD10copies/reactionPositive controlPseudovirus containing target fragments and internal standard fragmentsNegative controlPseudovirus containing internal standard fragmentsClinical Sensitivity100%Clinical Specificity99%1734Convergys POC RT-PCR COVID-19 Detectin Kit769Convergent TechnologiesGermanywww.convergent-technologies.deYesCommercialisedNoNoLab-basedNucleic acidhttps://convergent-technologies.de/product/convergys-poc-rt-pcr-covid-19-detection-kit/2021-05-10 13:04:001413Nucleic acid-PCRRT-PCR90LOD250cpmAnalytical Sensitivity100%Analitical Specificity100%Throughputsingle cartridges553CompleTest338FluroTest LLCCanadaflurotech.com/NoIn developmentNoNoLab-basedNucleic acid2021-05-10 13:04:00447Nucleic acid-PCRRT-PCR102Colorimetric and Isothermal Detection Kit for COVID-19 Coronavirus59Chinawww.bio2k.cn/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:0072Nucleic acid-PCRRT-PCRColorimetryisothermal339cobas SARS-CoV-2 (for use on the cobas 6800/8800 Systems)221ROCHE DiagnosticsSwitzerlanddiagnostics.roche.comYesCommercialisedNoNoLab-basedNucleic acidInfo available upon request 2021-05-10 13:04:00283Nucleic acid-PCRRT-PCR https://diagnostics.roche.com/global/en/products/params/cobas-sars-cov-2-test.htmlThroughputup to 384/1056 tests in an 8-hour shift, respectively305CleanPlex SARS-CoV-2 Research and Surveillance NGS Panel196Paragon Genomics IncUnited Stateswww.paragongenomics.com/NoCommercialisedNoNoNear POC / POCNucleic acid2021-05-10 13:04:00253Nucleic acid-OtherOtherPanelType of antigenSARS-CoV-2 antigens186CLART COVID-19109Genomica SauSpaingenomica.com/YesCommercialisedNoNoAutomatedManualNucleic acidvalidated at the National Center for Microbiology (Instituto de Salud Carlos III, Spanish National Reference Center) with a panel of 80 samples 2021-05-10 13:04:00144Nucleic acid-PCRRT-PCR300 http://genomica.com/covid-19/?lang=enClinical Sensitivity96%Clinical Specificity98%Throughput96samples/run (probe microarrays)715CirrusDx SARS-CoV-2 Assay409CirrusDx LaboratoriesUnited Stateswww.cirruslabs.io/NoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00563Nucleic acid-PCRRT-PCR128ChromaCode COVID-19 Six Target Single Well Assay70ChromaCodeUnited Stateschromacode.com/NoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:0089Nucleic acid-PCRRT-PCR712Childrens-Altona-SARS-CoV-2 assay401Boston Children's Hospital Infectious Diseases Diagnostic Laboratory (IDDL)United Stateswww.childrenshospital.org/centers-and-services/departments/infectious-diseases/infectious-diseases-fellowship-program/clinical-trainingNoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00550Nucleic acid-PCRRT-PCRType of antigenSARS-CoV-2 N antigens726CDI Enhanced COVID-19 Test433Hackensack University Medical Center (HUMC) Molecular Pathology LaboratoryUnited Stateswww.hackensackumc.org/services/laboratory-services/NoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00591Nucleic acid-PCRRT-PCR120CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel (CDC)66Centers for Disease Control and PreventionUnited Stateswww.cdc.gov/coronavirus/2019-ncov/lab/testing.htmlNoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:0084Nucleic acid-PCRRT-PCR760CareStart COVID-19 MDx RT-PCR321Access Bio, IncUnited Stateswww.accessbio.net/YesCommercialisedNoNoManualNucleic acidsamples: upper respiratory specimens (such as and nasopharyngeal wash/aspirate or nasal aspirate) and bronchoalveolar lavage https://accessbiodiagnostics.net/covid-19-mdx-rt-pcr/2021-05-10 13:04:00617Nucleic acid-PCRRT-PCRWHO-183 https://accessbiodiagnostics.net/wp-content/uploads/2020/07/EUA-access-carestart-ifu.pdfLOD10copies/reactionPositive controlN gene, RdRP gene, and MS2Negative controlnuclease free waterClinical Sensitivity100%Clinical Specificity100%Throughput100tests494careGENE N-CoV RT-PCR kit300Wells Bio, IncSouth Koreawww.wellsbio.net/eng/YesCommercialisedNoNoManualNucleic acidIncludes information about reproducibility 2021-05-10 13:04:00394Nucleic acid-PCRRT-PCR83 https://www.apacor.com/products/caregene-n-cov-rt-pcr-kit/LOD5copies/μlPositive controlpositive and internal controlAnalitical Specificitytested negative with 16 species of microorganisms493careGENE COVID-19 RT-PCR kit300Wells Bio, IncSouth Koreawww.wellsbio.net/eng/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00393Nucleic acid-PCRRT-PCR83Positive controlPositive control not specifiedType of antigenN gene as well as RdRP gene1597BTMED706Biotrack B.V.Netherlandswww.biotrack.nlYesCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:001278Nucleic acid-PCRRT-PCR30Automated lab-based, near-POC NAT or POC NAT LOD0.49cpuPositive control130 samples positive by RT-PCR and mild to severe symptomaticNegative control361 samples negative by RT-PCR and mild symptomaticAnalytical Sensitivity100%Analitical Specificity100%Clinical Sensitivity96.9%Clinical Specificity98.6%31Bosphore Novel Coronavirus (2019-nCoV) Detection Kit21Anatolia GeneworksTurkeywww.anatoliageneworks.com/YesCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:0025Nucleic acid-PCRRT-PCRPositive controlInternal controlThroughputSingle tubes1351BIOSYNEX AMPLIQUICK SARS-CoV-2651BIOSYNEX S.A.Francewww.biosynex.comYesCommercialisedNoNoAutomatedManualNucleic acid2021-05-10 13:04:001113Nucleic acid-PCRRT-PCR90 Information provided by the manufacturer: BIOSYNEX AMPLIQUICK SARS-CoV-2 is an in vitro molecular diagnostic test for the qualitative detection of SARS-CoV-2 (virus responsible for COVID-19) from an RNA extract obtained from a single nasopharyngeal or oropharyngeal swab. This test allows the detection of 2 specific molecular targets of SARS-CoV-2 located on RdRp and E genes. LOD1copies/μlwith extracted RNAPositive controlYes, Positive Control (CTRL +) is supplied in the kitNegative controlYes, Positive Control (CTRL -) is supplied in the kitAnalytical Sensitivity100%Analitical Specificity100%Clinical Sensitivity100%Clinical Specificity100%Throughput96 samples per run1352BIOSYNEX AMPLIQUICK Respiratory Triplex651BIOSYNEX S.A.Francewww.biosynex.comYesCommercialisedNoNoAutomatedManualNucleic acid2021-05-10 13:04:001114Nucleic acid-PCRYesRT-PCR90LOD1cpuPositive controlYes, Positive Control (CTRL +) is supplied in the kitNegative controlYes, Positive Control (CTRL -) is supplied in the kitAnalytical Sensitivity100%Analitical Specificity100%Clinical Sensitivity100%Clinical Specificity100%Throughput97samples/run518BioGX SARS-CoV-2 Reagents for BD MAX System42Becton DickinsonUnited Stateswww.bd.com/en-usNoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00422Nucleic acid-PCRRT-PCR https://biogx.com/news/becton-dickinson-biogx-get-fda-emergency-use-authorization-for-rapid-sars-cov-2-test1804BioFire® Respiratory 2.1plus Panel822bioMerieuxFrancewww.biomerieux-diagnostics.com/YesCommercialisedNoNoCartridgeAutomatedNucleic acidNasopharyngeal swabThe BioFire® Respiratory 2.1 plus Panel (CE-IVD) uses a syndromic approach (detects 23 pathogens, including SARS-CoV-2 simultaneously) to accurately detect and identify the pathogens most commonly associated with respiratory infections. Fast and comprehensive, the BioFire RP2.1 plus Panel offers a run time of about 45 minutes, enabling high efficiency and throughput on the BioFire® FilmArray® 2.0 and the BioFire® FilmArray® Torch Systems. Rapid respiratory PCR test results may enable better-informed diagnosis and treatment of patients. Quick turnaround on a broad menu of pathogens may also help clinicians make vital decisions regarding admission, isolation, cohorting, and additional diagnostic testing.2021-05-10 13:04:001483Nucleic acid-PCRYesRT-PCRQualitative45LOD160cpmPositive controlZeptoMetrix NATtrol™ SARS-Related Coronavirus 2 (SARS-CoV-2) External Run Control; NATSARS(COV2)-ERCAnalytical Sensitivity98%Analitical Specificity100%Clinical Sensitivity100%Clinical Specificity100%94BIOFIRE Respiratory Panel 2.1 (RP2.1)56bioMérieux SAFrancewww.biomerieux.com/NoIn developmentNoNoLab-basedNucleic acid2021-05-10 13:04:0066Nucleic acid-PCRRT-PCR710BioFire COVID-19 test400BioFire Defense, LLCUnited Stateswww.biofiredx.com/covid-19/NoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00549Nucleic acid-PCRRT-PCR758Biodesix SARS-CoV-2 Droplet Digital PCR (ddPCR ) Test398BiodesixUnited Stateswww.biodesix.com/NoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00615Nucleic acid-PCRDigital-PCR https://doi.org/10.1101/2020.02.29.20029439, https://doi.org/10.1101/2020.03.14.200361291402BioCore 2019-nCoV Real Time PCR Kit666BioCoreSouth Koreawww.bio-core.com/YesCommercialisedNoNoLab-basedNucleic acid http://www.bio-core.com/biocore/kr/common/Brochure_(ENG).pdf2021-05-10 13:04:001166Nucleic acid-PCRNoRT-PCR120LOD126.43copies/μlClinical Sensitivity100%Clinical Specificity100%1399BioCode SARS CoV-2 Assay kit663Applied BioCodeUnited Statesapbiocode.comNoCommercialisedNoNoLab-basedNucleic acidRNA Internal Control (RNA IC2: bacteriophageMS2) http://apbiocode.com/sars-cov-2.htm2021-05-10 13:04:001163Nucleic acid-PCRRT-PCR http://apbiocode.com/pdf/ABC_SARS-CoV-2_Package-Insert_Oct-2020.pdfLOD0.0172TCID50/mlClinical Sensitivity98%Clinical Specificity96.1%Throughput23hours525Bio-Speedy SARS-CoV-2 (2019-nCoV) qPCR Detection Kit323Turkeywww.bioeksen.com.trYesCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00427Nucleic acid-PCRRT-PCR https://bioeksen.com.tr/tr/covid-19-rt-qpcr-tespit-kiti/LOD5.6copies/reactionPositive controlWuhan-RdRp positive controlAnalytical Sensitivity99%Analitical Specificity99.4%1060Bio-Speedy Direct RT-qPCR SARS-CoV-2323Turkeywww.bioeksen.com.trYesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00839Nucleic acid-PCR65LOD89cpmrange: 89 - 562 cpmPositive controlSynthetic SARS-CoV-2 genom fragment and nucleic acid extract from human for RNase PNegative controlWater, DEPC-Treated, Molecular Biology Grade (CAS 7732-18-5)Analytical Sensitivity99.8%Analitical Specificity100%Clinical Sensitivity97.8%Clinical Specificity100%Throughput96samples/run541Bio-Rad SARS CoV-2 ddPCR Assay332Bio-Rad Laboratories, IncUnited Stateswww.bio-rad.com/NoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00441Nucleic acid-PCRDigital-PCR706BD SARS-CoV-2 Reagents for BD MAX System42Becton DickinsonUnited Stateswww.bd.com/en-usYesCommercialisedNoNoLab-basedNucleic acidInfo available upon request no info can be extracted2021-05-10 13:04:00545Nucleic acid-PCRRT-PCR https://www.bd.com/en-us/offerings/capabilities/molecular-diagnostics/molecular-tests/bd-sars-cov-2-reagents704BakoDx SARS-CoV-2 RNA test396Bako DiagnosticsUnited Statesbakodx.com/NoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00544Nucleic acid-PCRRT-PCR48Avellino SARS-CoV-2/COVID-19 (AvellinoCoV2)31Avellino LabUnited Stateswww.avellino.com/en/NoIn developmentNoNoLab-basedNucleic acidLab test; EUA planned2021-05-10 13:04:0036Nucleic acid-PCRRT-PCR774Atlas COVID-19 Real Time RT-PCR Kit314Atlas MedicalUnited Kingdomatlas-medical.com/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00628Nucleic acid-PCRNoRT-PCR http://atlas-medical.com/upload/productFiles/229/PPI2014A01%20COVID-19%20PCR%2096%20TEST%20%20Rev%20A%20-%20Copy.pdfLOD500IU/mlPositive controlPositive control not specifiedNegative controlNegative control not specifiedAnalytical Sensitivity100%43Atila iAMP COVID-2019 Detection Kit26Atila BioSystems, IncUnited Stateswww.atilabiosystems.com/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:0031Nucleic acid-PCRRT-PCR https://www.fujirebio.com/en/news-events/iamp-covid19-detection-kit-a-molecular-sarscov2-detection-assay-distributed-by481ARIES SARS-CoV-2 Assay161Luminex Corp.United Stateswww.luminexcorp.com/NoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00386Nucleic acid-PCRRT-PCR143Aridia COVID-19 Real Time PCR Test79CTK Biotech, IncUnited Stateswww.ctkbiotech.com/YesCommercialisedNoNoManualNucleic acidInfo available upon request 2021-05-10 13:04:0099Nucleic acid-PCRRT-PCR https://www.trademed.com/products/9000/COVID-19-Real-Time-PCR-Test.htmlAnalytical Sensitivity95.1%Analitical Specificity95.9%944AQ-TOP COVID-9 Rapid Detection Kit227SEASUN BIOMATERIALSSouth Koreawww.seasunbio.com/english/YesCommercialisedNoNoManualNucleic acid http://en.diagreat.com/Private/Files/20200402/6372142153955462414330732.pdf 2021-05-10 13:04:00746Nucleic acid-PCRYesRT-PCR30 http://www.seasunbio.com/english/images/pdf/IFU%20AQ-TOP%20COVID-19%20rapid%20molecular%20test.pdfLOD7copies/μlPositive controlSARS-CoV-2 Orf1ab and the human RNase P geneNegative controlNuclease-free waterClinical Sensitivity100%Clinical Specificity100%972Aptima SARS-CoV-2 Assay (Panther System)133HologicUnited Stateswww.hologic.comYesCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00760Nucleic acid-PCRRT-PCR140 https://www2.hologic.com/pantherfusion-sars-cov-2#658Apparatus Detection Kit for Novel Coronavirus 2019-nCoV RNA (RT-PCR Fluorescence Probing)389Jiangxi YeLi MedicalChinawww.yelimed.cn/NoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00537Nucleic acid-PCRRT-PCR362AmpSure 2019-nCov RNA Assay240Shanghai Rendu Biotechnology Co., LtdChinawww.rdbio.com/YesCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00303Nucleic acid-PCRRT-PCR509AmpliTest SARS-CoV-2 (Real Time PCR)305Amplicon LtdPolanden.amplicon.pl/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00403Nucleic acid-PCRNoRT-PCR https://en.amplicon.pl/sars-cov-2/LOD7,09 copies of viral genome/assay or 0,89 copies of viral genome/1 µL of RNA preparationAnalitical Specificity"The kit does not detect other viruses that cause infections in humans" as stated on the websiteThroughputsingle tubes491AMPLIRUN TOTAL SARS-CoV-2 CONTROL (SWAB)78Vircell S.L.Spainwww.vircell.com/NoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00392Nucleic acid-PCRRT-PCR629AMPLIRUN SARS-CoV-2 RNA CONTROL78Vircell S.L.Spainwww.vircell.com/NoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00517Nucleic acid-PCRRT-PCR490AMPLIRUN CORONAVIRUS SARS (2003) RNA CONTROL78Vircell S.L.Spainwww.vircell.com/NoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00391Nucleic acid-PCRRT-PCR935Amplidiag COVID-19177MobidiagUnited Kingdommobidiag.com/YesCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00735Nucleic acid-PCRRT-PCR180 https://mobidiag.com/products/coronavirus/#Amplidiag-COVID-19Throughput48samples281ampliCube Coronavirus SARS-CoV-2725Mikrogen DiagnostikGermanywww.mikrogen.deYesCommercialisedNoNoManualNucleic acid2021-05-10 13:18:20232Nucleic acid-PCRRT-PCR120 https://www.mikrogen.de/produkte/produktuebersicht/testsystem/coronavirus-panel.htmlLOD1.5copies/reactionrange: 1.5-2.2Positive controlInternal controlThroughputsingle tubes282ampliCube Coronavirus Panel725Mikrogen DiagnostikGermanywww.mikrogen.deYesCommercialisedNoNoManualNucleic acid2021-05-10 13:18:20233Nucleic acid-PCRRT-PCR180 https://www.mikrogen.de/produkte/produktuebersicht/testsystem/coronavirus-panel.htmlPositive controlyesNegative controlyes29AmoyDx Novel Coronavirus (2019 nCoV) Detection Kit20Amoy Diagnostics Co., LtdChinawww.amoydiagnostics.com/index.htmlYesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:0024Nucleic acid-PCRNoRT-PCR180 http://www.amoydiagnostics.com/productDetail_40.htmlLOD500copies/mlThroughputSingle tubes831Amela SARS CoV-2 Real time PCR Detection kit478Amedica SANetherlandswww.amedicagroup.com/YesCommercialisedNoNoManualNucleic acidthe kit exists on the website but no info can be extracted2021-05-10 13:04:00662Nucleic acid-PCRNoRT-PCR https://amedicagroup.com/19AMD Human SARS-CoV-2 detection kit15Advanced Molecular DiagnosticsUnited Kingdomam-diagnostics.co.uk/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:0019Nucleic acid-PCR http://am-diagnostics.co.uk/molecular-assays/zena-max-covid-19LOD1copies/rxnPositive controlinternal positive control assay (highly conserved region of human RNA)Analitical Specificity100%ThroughputSingle tubes1128Allplex SARS-CoV-2 Assay597ARROW DIAGNOSTICS SRL ITItalywww.arrowdiagnostics.it/it/home/YesCommercialisedNoNoAutomatedManualNucleic acid multiplex real-time PCR assay to detect 4 target genes of SARS-CoV-2, specimens: Nasopharyngeal swab- Nasopharyngeal aspirate- Throat swab- Bronchoalveolar lavage- Sputum; Analytes:- N gene- S gene- RdRP gene- E gene - Internal Control (IC) ; No cross-reactivity confirmed with 54 respiratory pathogens including SARS, MERS and SARS-related viruses 2021-05-10 13:04:00911Nucleic acid-PCRNoRT-PCR120 http://www.arrowdiagnostics.it/download/microbiologia/infezionirespiratorie/BROCHURE_Allplex%20SARS-CoV-2.pdfLOD50copies/reactionPositive control4 target genes: N gene; S gene; RdRP gene; E gene348Allplex 2019-nCoV assay229Seegene, IncSouth Koreawww.seegene.com/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00292Nucleic acid-PCRRT-PCR110 http://www.seegene.com/assays/allplex_2019_ncov_assay#LOD100copies/mlPositive controlyesNegative controlyesAnalitical Specificitytested negative with 61 species of microorganisms.Clinical Sensitivity100%(49/49) [95% CI: 92.75% - 100.00%],Clinical Specificity94%(94/100) [95% CI: 87.40% - 97.77%]Throughputsingle tubes1042Alinity m SARS-CoV-2 AMP Kit548Abbott Molecular IncUnited Stateswww.molecular.abbottYesCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00802Nucleic acid-PCRRT-PCR115LOD100cpmPositive controlPositive control included in SARS-CoV-2 CTRL kit. Internal control included in every reaction.Negative controlNegative control available as part of SARS-CoV-2 CTRL kit.Analytical Sensitivity100%Analitical Specificity100%Clinical Sensitivity100%Clinical Specificity96.5%Throughput96samples/run177Advanced One Step FAST Covi19 KIT Two Genes Set102GeneMePolandwww.geneme.eu/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00134Nucleic acid-PCRRT-PCR https://geneme-koronawirus.pl/product/2Positive controlInternal and positive controls, not specifiedThroughputSingle tubes2020AddMedi SARS-CoV-2 RT-qPCR Kit928Addbio Meditek Co.South Koreawww.addbiomeditek.comYesCommercialisedNoNoOtherStripAutomatedNucleic acidBronchoalveolar lavage fluidNasopharyngeal swabOropharyngeal swabThe principle of test is based on TaqMan Real-Time qPCR. After open the Kit box, resuspend the 5X RT-qPCR buffer (5X Buffer, 400㎕), 20X Enzyme Solution (ES, 100㎕), 4X Oligo mixture (4X OM, 500㎕), Positive control (PC, 100㎕), and DEPC water for Negative Control (NC, 100㎕). Aliquot the 5X RT-qPCR buffer (4㎕), 20X Enzyme Solution (1㎕), 4X Oligo mixture (5㎕), RNA template (5 or 10㎕), PC (10㎕) and remain volume should be adjusted with DEPC to the reaction volume of 20㎕ into the PCR tube or plate for the chosen PCR platform.2021-05-10 13:04:001698Nucleic acid-PCRNoRT-PCRQualitativeOtherValidity test kit109LOD50 copiesPositive controlS gene (FAM): 21 ct; RdRp gene (HEX): 21 ct and IPC (Cy5): 21 ctNegative controlOnly IPC amplifyAnalytical Sensitivity100%Analitical Specificity100%Clinical Sensitivity96%Clinical Specificity100%530Acu-Corona 2.0/3.0 SARS-CoV-2 Real-time PCR Kits325BIOTECON Diagnostics GmbHGermanywww.bc-diagnostics.com/NoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00432Nucleic acid-PCRRT-PCR15Acu-Corona 2.012Acumen Research Laboratories Pte LtdSingaporewww.acumen-research.com/NoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:0015Nucleic acid-PCRRT-PCR16Acu-Corona12Acumen Research Laboratories Pte LtdSingaporewww.acumen-research.com/NoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:0016Nucleic acid-PCRNoRT-PCRManual NAT 763Accuster SARS-COV2-RT-PCR test kit452Accuster Technologies Pvt LtdIndiawww.accuster.com/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00619Nucleic acid-PCRRT-PCR187AccuraTect RT-qPCR SARS-CoV-2110Genomictree, IncSouth Koreawww.genomictree.comYesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00145Nucleic acid-PCRRT-PCRLOD100copies/reactionPositive controlInternal control (human RNAse P gene)Positive controlNegative controlSARS-CoV negative controlAnalitical Specificity44 microorganisms in the cross-reactivity in silico assessmenttested negative with 35 species of microorganismsClinical Sensitivity100%Clinical Specificity100%Throughputsingle tubes528AccuPower SARS-CoV-2 Real-Time RT-PCR kit (manual kit: SCV-2122)324BIONEER CorporationSouth Koreawww.bioneer.com/YesCommercialisedNoNoManualNucleic acidMastermix type kit 2021-05-10 13:04:00430Nucleic acid-PCRRT-PCR https://eng.bioneer.com/20-scv-2122.html527AccuPower COVID-19 Real-Time RT-PCR kit (lab-based automated kit: NCV-1111)324BIONEER CorporationSouth Koreawww.bioneer.com/YesCommercialisedNoNoAutomatedLab-basedNucleic acid2021-05-10 13:04:00429Nucleic acid-PCRRT-PCR https://eng.bioneer.com/20-ncv-1111.htmlThroughputPremix type kit736Accula SARS-CoV-2 test437Mesa BiotechUnited Stateswww.mesabiotech.com/NoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00596Nucleic acid-PCRRT-PCR468abTES COVID-19 qPCR I Kit289AITbiotechSingaporeaitbiotech.com/YesCommercialisedNoNoCassetteLab-basedNucleic acidhttp://en.keweidiagnostic.com/uploadfile/2020/0702/20200702085141757.pdf 2021-05-10 13:04:00376Nucleic acid-PCRRT-PCR90 https://labmal.com/product/abtes-covid-19-qpcr-i-kit/Throughputsingle tubes8Abbott RealTime SARS-CoV-2 EUA test6AbbottUnited Stateswww.abbott.com/YesCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:008Nucleic acid-PCRRT-PCR https://www.fda.gov/media/136258/downloadLOD100copies/mlPositive controlRNA added to each reaction, not specifiedNegative controlno template tubeAnalytical Sensitivity100%using spiked samplesAnalitical Specificity100%tested negative with 31 species of micoorganismsNPA 100% using spiked samplesThroughputSingle tubes876ABBOTT REALTIME SARS-COV-2 ASSAY6AbbottUnited Stateswww.abbott.com/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00695Nucleic acid-PCRRT-PCR420 https://www.molecular.abbott/int/en/products/infectious-disease/RealTime-SARS-CoV-2-AssayLOD100copies/mlPositive controlPositive control not specifiedAnalitical Specificity100%Throughput470samplesin 24 hours1041Abbott RealTime SARS-CoV-2548Abbott Molecular IncUnited Stateswww.molecular.abbottYesCommercialisedNoNoLab-basedNucleic acid Data provided by the Manufacturer2021-05-10 13:04:00795Nucleic acid-PCRRT-PCR360 Information provided by the manufacturerLOD100cpmPositive controlPositive control included in SARS-CoV-2 Control kit. Internal control included in every reaction.Negative controlNegative control available as part of SARS-CoV-2 Control kit.Clinical Sensitivity100%Clinical Specificity100%Throughput96samples/run496Abbott ID NOW COVID-196AbbottUnited Stateswww.abbott.com/YesCommercialisedNoNoNear POC / POCNucleic acid2021-05-17 10:28:291550Nucleic acid-PCROtherThe method is based on a novel isothermal amplification technique termed NEAR (Nicking endonuclease amplification reaction).13A*STAR Fortitude Kit 2.0 (Singapore HSA) – PCR kit10A*ccelerateSingaporewww.accelerate.tech/NoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:0013Nucleic acid-PCRRT-PCR504A*STAR Fortitude Kit 2.010A*ccelerateSingaporewww.accelerate.tech/NoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00401Nucleic acid-PCRRT-PCRManual NAT 3818-minute RT-qPCR direct PCR testing system for SARS-CoV-2 detection250Star Array Ptd. LtdSingaporewww.star-array.com/NoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00313Nucleic acid-PCRRT-PCR43DMed 2019-nCoV RT-qPCR Detection Kit23D MedicinesChinawww.3dmedcare.com/YesCommercialisedNoNoN.A.ManualNucleic acid2021-05-10 13:04:005Nucleic acid-PCRRT-PCR http://www.3dmedcare.com/UploadImage/covid/01%20IFU%20for%203DMed%202019-nCoV%20RT-qPCR%20Detection%20Kit.pdfLOD5RNA-copies/test5.00 RNA copies/testPositive controlpositive control, process control, internal control ( MS2 RNA)Negative controlyesAnalitical Specificitytested negative with 27 species of microorganismsClinical Sensitivity96%PPA 96-100% compared to NGS assays and CDC methodClinical Specificity100%NPA 100%-100% compared to NGS and CDC methodThroughputSingle tubes16232019-Novel Coronavirus, Influenza Virus, Respiratory Syncytial Virus Nucleic Acid Test Kit (Fluorescent Probe-based real-time PCR assay)753Jiangsu Mole Bioscience CO., LTDChinaen.molechina.com/YesCommercialisedNoNoManualNucleic acid This kit uses polymerase chain reaction (PCR) technology based on TaqMan fluorescent probe to detect ORF1ab gene of 2019-Novel Coronavirus, M1 gene or NS1 gene of Influenza Virus and F gene of RSV from specimens including Oropharyngeal swabs, sputum and bronchoalveolar lavage fluid collected from the patients or suspected patients.2021-05-10 13:18:201303Nucleic acid-PCRRT-PCR32LOD: influenza virus: 400 copies/ml; RSV: 200 copies/mlLOD100copies/ml2019-nCoVPositive controlArmored RNA of nCoV, Flu, RSV and Internal ControlNegative controlPlasmid of Internal ControlAnalytical Sensitivity100%Analitical Specificity100%Clinical Sensitivity98.67%Clinical Specificity99.32%Throughput96samples/run16212019-Novel Coronavirus, Influenza A and B virus nucleic acid test kit (Fluorescent Probe-based real-time PCR assay753Jiangsu Mole Bioscience CO., LTDChinaen.molechina.com/YesCommercialisedNoNoManualNucleic acid http://en.molechina.com/Home/ProductInfo/42021-05-10 13:18:201301Nucleic acid-PCRRT-PCR32 LOD: Influenza A H1N1(2009): 180 copies/ml; Influenza A H1N1: 80 copies/ml; Influenza A H3N2: 120 copies/ml; Influenza A H5N1: 800 copies/ml ; Influenza A H7N9: 200 copies/ml; Influenza B Victoria: 200 copies/ml; Influenza B YamagatLOD137copies/ml2019-nCoV Positive controlArmored RNA of nCoV, IFA, IFB and Internal ControlNegative controlNo targetsAnalytical Sensitivity100%Analitical Specificity100%Clinical Sensitivity98.28%Clinical Specificity99.68%Throughput96samples/run1619753Jiangsu Mole Bioscience CO., LTDChinaen.molechina.com/YesCommercialisedNoNoManualNucleic acid2021-05-10 13:18:201299Nucleic acid-PCRRT-PCR70 http://en.molechina.com/Home/ProductInfo/1LOD500copies/mlPositive controlArmored RNA of nCoV and Internal ControlNegative controlNo targetsAnalytical Sensitivity100%Analitical Specificity100%Clinical Sensitivity98.81%Clinical Specificity99.5%Throughput96samples/run3952019-Novel Coronavirus (COVID-19) Real Time PCR Kit256Systaaq Diagnostic ProuductsUnited Stateswww.systaaq.com/YesCommercialisedNoNoManualNucleic acid https://www.testlinecd.com/file/1580/COVID-19_AN_NEW%20(002).pdf?version=202008131535 2021-05-10 13:04:00320Nucleic acid-PCRRT-PCR https://www.systaaq.com/product/covid-19/LOD10copies/mlPositive controlyesNegative controlyesThroughputsingle tubesType of antigennucleocapsid recombinant antigen2912019-Novel Coronavirus (2019-nCoV) Triplex RT-qPCR Detection Kit184Nanjing Vazyme Medical Technology Co., LtdChinawww.vazymebiotech.com/YesCommercialisedNoNoManualNucleic acid Time: 20 minutes 2021-05-10 13:04:00241Nucleic acid-PCRRT-PCR https://v1.cecdn.yun300.cn/site_1807300040/CD302-02-Manual%20CE%20IVD%200312(1).pdfLOD200copies/mlPositive controlPositive control (RNA pseudovirus)Negative controlDEPC distilled waterAnalytical Sensitivity100%Conformity rate of Positive Control: 100%Analitical Specificity100%Conformity rate of Negative Control: 100% tested negative with at least 7 species of microorganismsThroughputsingle tubesType of antigenSARS-CoV-2 viral proteins (nucleoprotein)3582019-Novel Coronavirus (2019-nCoV) RT-PCR Detection Kit236Shanghai Fosun Long March Medical Science Co., LtdChinaen.lm-diagnostics.com.cn/NoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00299Nucleic acid-PCRRT-PCR18082019-nCoV/IAV/IBV Nucleic Acid Test Kit (PCR- fluorescence probe method)779Guangdong Hecin Scientific, Inc.Chinawww.hecin-scientific.cn/YesCommercialisedNoNoMicroplateManualNucleic acid2021-05-10 13:04:001485Nucleic acid-PCRRT-PCRQualitativeFluorescencePositive controlYesNegative controlYes11582019-nCoV TaqMan RT-PCR Kit Dx (DxTM67100)189Norgen Biotek Corp.Canadanorgenbiotek.com/YesCommercialisedNoNoManualNucleic acid https://norgenbiotek.com/product/2019-ncov-taqman-rt-pcr-kit-dx2021-05-10 13:04:00940Nucleic acid-PCRRT-PCR45LOD10virus-copiesPositive controlcontains the CDC 2019-nCoV markers (N1 and N2) and RNase P gene Negative controlNuclease-free waterAnalytical Sensitivity100%Analitical Specificity100%Throughput96samples/run2982019-nCoV TaqMan RT-PCR Kit (Catalog# TM67100)189Norgen Biotek Corp.Canadanorgenbiotek.com/NoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00246Nucleic acid-PCRRT-PCR22019-nCoV RT-qPCR23D MedicinesChinawww.3dmedcare.com/YesCommercialisedNoNoManualNucleic acidPerformance of 3D 2019-nCoV RT-qPCR Detection Kit has only been established in the specimens collected with oropharyngeal swabs and nasopharyngeal swabs. 2021-05-10 13:04:002Nucleic acid-PCRNoRT-PCR http://www.3dmedcare.com/UploadImage/covid/01%20IFU%20for%203DMed%202019-nCoV%20RT-qPCR%20Detection%20Kit.pdfLOD5RNA-copies/testPositive controlORF1ab, N and E gene. Internal controlNegative controlNot foundAnalitical Specificitytested negative with 27 species of Viruses/Bacteria/ParasitesClinical Sensitivity96%PPA 96-100% compared to NGS assays and CDC methodClinical Specificity100%NPA 100%-100% compared to NGS and CDC methodThroughputSingle tubes1882019-nCoV qRT-PCR Detection Assay111GenScriptNetherlandswww.genscript.comNoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00146Nucleic acid-PCRRT-PCR1342019-nCoV Prep Free QPCR Assay856Coyote Bioscience Co., Ltd.Chinawww.coyotebio.com/gykydYesIn developmentNoNoLab-basedNucleic acid2021-05-10 13:18:2093Nucleic acid-PCRRT-PCR 732019-nCoV ORF1ab/N Gene Detection Kit (Fluorescence PCR Method)45Beijing Kinhawk Pharmaceutical Co., LtdChinawww.kinghawk828.com/NoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:0052Nucleic acid-PCRRT-PCRFluorescenceManual NAT 18052019-nCoV Nucleic Acid Test Kit (PCR- fluorescence probe method)779Guangdong Hecin Scientific, Inc.Chinawww.hecin-scientific.cn/YesCommercialisedNoNoCassetteManualNucleic acidhttps://www.hecin-scientific.cn/productinfo/76910.html?templateId=1751662021-05-10 13:04:001486Nucleic acid-PCRRT-PCRFluorescence832019-nCoV nucleic acid detection kit using combinatorial probe-anchor synthesis method50BGIChinawww.bgi.com/global/NoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:001523Nucleic acid-PCRRT-PCR12172019-nCoV Nucleic Acid Detection Kit (RT-IMSA Method)569Guangdong Longsee Biomedical Co., LtdChinawww.longseemed.comYesCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:001000Nucleic acid-PCRNoRT-PCR40LOD300AUPositive control100AUNegative control0AUAnalytical Sensitivity99%Analitical Specificity96%Clinical Sensitivity99%Clinical Specificity95%Throughput86samples/run10572019-nCoV Nucleic Acid Detection Kit (Q-PCR Method)569Guangdong Longsee Biomedical Co., LtdChinawww.longseemed.comNoCommercialisedNoNoAutomatedManualNucleic acid2021-05-10 13:04:00835Nucleic acid-PCRRT-PCR60836Nucleic acid-PCRRT-PCR240Throughput96samples/run8882019-nCov nucleic acid (Fluorescence PCR)23Anlong GeneChinawww.anlongen.com/YesCommercialisedNoNoAutomatedManualNucleic acidUsing Google translate 2021-05-10 13:04:00700Nucleic acid-PCRNoRT-PCR https://www.anlongen.com/news/detail.html?id=55LOD300copies/ml2132019-nCoV Direct RT-qPCR Kit129Hangzhou Dan Wei Biotechnology Co.LtdChinaNoIn developmentNoNoManualNucleic acid2021-05-10 13:04:00169Nucleic acid-PCRRT-PCR782019-nCoV Detection kit (quantum dot immunofluorescence method)48Beijing Shengkun Kangru Medical Equipment Co., LtdChinawww.dhymedical.com/NoIn developmentNoNoAutomatedManualNucleic acid2021-05-10 13:04:0055Nucleic acid-PCRquantum dot immunofluorescence method7332019-nCoV CDC-qualified Probe and Primer Kits for SARS-CoV-2436Biosearch TechnologiesUnited Kingdomwww.biosearchtech.com/NoCommercialisedNoNoLab-basedNucleic acid2021-05-10 13:04:00595Nucleic acid-PCRN.A.RT-PCR 7302019 Novel Coronavirus Real-time PCR Kit151Kogene BiotechSouth Koreawww.kogene.co.kr/eng/YesCommercialisedNoNoManualNucleic acidBased on WHO and CDC reference methods 2021-05-10 13:04:00594Nucleic acid-PCRRT-PCRPositive controlE gene, RdRp. Internal control3002019 Novel Coronavirus PCR191Northwell HealthUnited Stateswww.northwell.edu/NoIn developmentNoNoLab-basedNucleic acid2021-05-10 13:04:00248Nucleic acid-PCRRT-PCR2012019 Novel Coronavirus (2019-nCoV) RNA ASSAY (PCR Fluorescent Probe Method)120Guangzhou HEAS BioTech Co., LtdChinawww.heasbio.com/NoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00158Nucleic acid-PCRRT-PCRType of antigenNucleocapsid, Spike 1 and Spike 28952019 New Coronavirus (2019-nCoV) Test Kit497AnitoaChinawww.anitoa.com/NoCommercialisedNoNoAutomatedManualNucleic acid2021-05-10 13:04:00707Nucleic acid-PCRRT-PCRManual or automated 4172019 nCoV Real-Time RT-PCR Diagnostic Panel66Centers for Disease Control and PreventionUnited Stateswww.cdc.gov/coronavirus/2019-ncov/lab/testing.htmlNoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00340Nucleic acid-PCRRT-PCR11copy COVID-19 qPCR Kit11drop IncSouth Koreawww.1drop.co.kr/YesCommercialisedNoNoManualNucleic acidBased on KCDC method 2021-05-10 13:04:001Nucleic acid-PCRRT-PCR https://www.jenabioscience.com//files/jenabioscience/datasheet_extern/PCR-703.pdfLOD200copies/mlPositive controlE gene plasmid and RdRp gene plasmidNegative controlDEPC distilled waterThroughputSingle tubes617(SDI) SARS-CoV-2 Qualitative Real Time PCR Kit370Spectrum for Diagnostic IndustriesEgyptwww.spectrum-diagnostics.com/NoCommercialisedNoNoManualNucleic acid2021-05-10 13:04:00511Nucleic acid-PCRN.A.RT-PCRManual NAT 1941COVID-19 Antibody Rapid Test Kit (IgM)886Chongqing iSIA BIO-Technology Co., LtdChinawww.isiabio.com.cnYesCommercialisedNoNoCassetteNear POC / POCIgMPlasmaSerumWhole bloodtest results good2021-05-10 13:04:001617Immuno-AntibodyImmunochromatographyColloidal gold15LOD0.8AUCalibrationNot evaluatedCrossreactivityEvaluatedFp1AUFn0AUPrecisionEvaluatedAccuracy97% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97% IgMClinical Specificity97% IgMType of antigenOther17942019-nCoV-IgM Assay Reagent Kit (CMIA)344Hangzhou Realy Tech Co., LtdChinawww.realytech.com/YesCommercialisedNoNoOtherNear POC / POCIgMSerum2021-05-10 13:04:001473Immuno-AntibodyYesImmunoassayQualitativeChemiluminescence40Fp0.97%Fn7.78%Accuracy98.17%Clinical Sensitivity92.22%302New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel193NY State Department of HealthUnited Stateswww.wadsworth.org/NoCommercialisedNoNoLab-basedIgGIgMIgANucleic acid2021-05-10 13:04:00250Nucleic acid-PCRRT-PCRType of antigenSARS-CoV-2 Nucleocapsid recombinant antigen1978Suresign Professional 2019-nCoV IgG/IgM Rapid Test Cassette (Whole Blood, Serum, Plasma))905CIGA Healthcare Ltd.United Kingdomwww.cigahealthcare.com/YesCommercialisedNoNoCassetteNear POC / POCIgGIgMPlasmaSalivaWhole bloodthe product was registered with the MHRA on 9th September 20202021-05-10 13:04:001654Immuno-AntibodyNoImmunoassayQualitativeMembrane-based10LOD2.5AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0.6%Fn14%PrecisionEvaluatedAccuracy96.1%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity97.6%Clinical Specificity95.9%Type of antigenNucleoprotein1787SCREEN TEST COVID-19 IgG/IgM - 2019-nCoV IgG/IgM Rapid Test Cassette701SCREEN ITALIA S.r.l.Italywww.screenitalia.itYesCommercialisedNoNoCassetteLateral flowManualIgGIgMPlasmaSerumWhole blood2021-05-10 13:18:201466Immuno-AntibodyYesNoImmunochromatographyQualitative15LOD0U/mlCalibrationEvaluatedCrossreactivityEvaluatedFp4.76% IgGIgG: 1 on 21 Fp10.5% IgMIgM: 2 on 19Fn0% IgGIgG: 0 on 49Fn5.88% IgMIgM: 3 on 51PrecisionEvaluatedAccuracy98.6%(95% CI: 92.3%-99.96%) Accuracy92.9(95% CI: 84.1%-97.6%)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%(95% CI: 86.0%-100%)Clinical Sensitivity85%(95% CI: 62.1%-96.8%)1872SARS-CoV-2 IgM/IgG Test Kit(Colloidal Gold)859Foregene Co., LtdChinawww.foregene.comYesCommercialisedNoNoCassetteManualIgGIgMVenous whole bloodWhole bloodEC Representative SUNGO Europe B.V. Address: Olympisch Stadion 24, 1076DE Amsterdam, Netherlands2021-05-10 13:04:001554Immuno-AntibodyNoOtherQualitativeColorimetryOther10LOD200CalibrationEvaluatedCrossreactivityEvaluatedFp91.07%Fn95.37%PrecisionEvaluatedAccuracy92.75%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity91.07%Clinical Specificity95.37%Type of antigenNucleoprotein1755SARS-CoV-2 IgG/IgM Rapid Test Cassette (Colloidal Gold Method)840Wuhan NanoDiagnosis for Health Biotechnology Co., LtdChinandh-biotech.comYesCommercialisedNoNoCassetteNear POC / POCIgGIgMPlasmaSerumWhole blood2021-05-10 13:18:201433Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15LOD0U/mlCalibrationNot EvaluatedCrossreactivityEvaluatedFp85.71% IgM5/105Fp92.13% IgG10/127Fn95.49% IgG6/133Fn98.67% IgM6/125PrecisionEvaluatedAccuracy93.85%IgGAccuracy90.87%IgMReproducibilityEvaluatedReproducibilityEvaluatedRobustnessNot EvaluatedClinical Sensitivity92.13%IgGClinical Sensitivity85.71%IgM1752RAPIDAN TESTER SARS-CoV-2 IgM/IgG Ab Test758TurklabTurkeywww.turklab.com.tr/YesCommercialisedNoNoCassetteNear POC / POCIgGIgMPlasmaSerumWhole blood2021-05-10 13:18:201430Immuno-AntibodyNoImmunochromatographyQualitative15LOD0AUCalibrationNot EvaluatedCrossreactivityEvaluatedAccuracy96.17% IgGAccuracy93.33% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.88% IgGClinical Sensitivity87.54% IgM1903Rapid New Coronavirus (COVID19) IgG/IgM Combo Test806Immunospark s.r.l.Italywww.immunospark.comYesCommercialisedNoNoCassetteManualNear POC / POCIgGIgMPeripheral bloodPlasmaSerumWhole bloodMore information available in detailes report of the technicla file!2021-05-10 13:04:001579Immuno-AntibodyNoImmunochromatographyQualitativeColorimetryOther15LOD30AUCalibrationEvaluatedCrossreactivityEvaluatedFpA smal amount of results did not correltaed with the reference but correlated with rapid testFnA smal amount of results did not correltaed with the reference but correlated with rapid testPrecisionEvaluatedAccuracy99%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98%Clinical Specificity98%Type of antigenOther1785Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold)801Medakit LtdHong Kong S.A.Rwww.medakit.comYesCommercialisedNoNoCassetteNear POC / POCIgGIgMPlasmaSerumWhole bloodEvaluated by Institut Pasteur in France, the Medakit antibody tests is regulated by the ANSM . Medakit tests are published on the official website of the French Ministry of Health, on their approved covid test list2021-05-10 13:04:001464Immuno-AntibodyNoImmunoassayQualitativeColorimetry10LOD0.5AUFp3AUFn10AUAccuracy98.12%Clinical Sensitivity96.98%1753INFO SARS-CoV-2 IgM/IgG Ab Test758TurklabTurkeywww.turklab.com.tr/YesCommercialisedNoNoCassetteNear POC / POCIgGIgMPlasmaSerumWhole bloodSARS-CoV-2 IgM/IgG Antibody Test is a rapid immunochromatographic assay for qualitatively detection IgG and IgM antibodies of coronavirus disease in human serum, plasma or whole blood.2021-05-10 13:18:201431Immuno-AntibodyYesNoImmunochromatographyQualitative15LOD0U/mlCalibrationNot evaluatedCrossreactivityEvaluatedPrecisionEvaluatedAccuracy96.17% IgGAccuracy93.33% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.88% IgGClinical Sensitivity87.54% IgM325Hightop COVID-19 IgM/IgG Ab Rapid Test Kit286Qingdao Hightop Biotech Co., LtdChinawww.hightopbio.com/YesCommercialisedNoNoCassetteNear POC / POCIgGIgMPlasmaSerumWhole blood2021-05-10 13:04:00661Immuno-AntibodyYesNoImmunochromatographyQualitativeColorimetry15Rapid diagnostic test cassetteLOD100U/mlCalibrationEvaluatedCrossreactivityEvaluatedFp4%Fn7%PrecisionEvaluatedAccuracy92.8IgMAccuracy96.5%IgGReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity82%IgMClinical Sensitivity93%IgGType of antigenNucleoprotein1676COVID-19 IgG/IgM Test Cassette (for Analyzer)890Acro Biotech IncUnited Stateswww.acrobiotech.comYesCommercialisedNoNoCassetteNear POC / POCIgGIgMPlasmaSerumWhole blood2021-05-10 13:18:201355Immuno-AntibodyYesNoImmunoassayQualitative15LOD0AUCalibrationevaluatedCrossreactivityevaluatedFp3.1AUFn3.3AUPrecisionevaluatedAccuracy96.9%(IgG, IgM)ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity96.7%(IgG/IgM)1760Asan Easy Test COVID-19 IgG/IgM741Asan Pharmaceutical CO., LTDSouth Koreawww.asanpharm.comYesCommercialisedNoNoCassetteManualIgGIgMSerumWhole blood2021-05-10 13:04:001438Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15LOD0.2U/mlCalibrationNot evaluatedCrossreactivityEvaluatedFp13AUFn12AUPrecisionEvaluatedAccuracy95.38%RobustnessNot evaluatedClinical Sensitivity95%Type of antigenNucleoprotein1675ACON SARS-CoV-2 IgG/IgM Rapid Test683ACON Laboratories, IncUnited Stateswww.aconlabs.comYesCommercialisedNoNoCassetteNear POC / POCIgGIgMPlasmaSerumWhole blood2021-05-10 13:04:001354Immuno-AntibodyYesNoImmunoassayQualitative15LOD1AUCalibrationnot evaluatedCrossreactivityevaluatedPrecisionevaluatedAccuracy98.3%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity98.89%14Accu-Tell COVID-19 IgG/IgM Rapid Test Cassette11AccuBioTech Co. LtdBelgiumwww.accubiotech.comYesCommercialisedNoNoStripNear POC / POCIgGIgMWhole blood2021-05-10 13:04:0014Immuno-AntibodyYesNoImmunoassayQualitative10Accuracy98.9% IgGAccuracy96.1% IgMClinical Sensitivity97.4% IgGClinical Sensitivity86.8% IgMClinical Specificity99.3% IgGClinical Specificity98.6% IgM1740SARS-CoV-2 S IgG ELISA775UAB ImunodiagnostikaLebanonwww.allergomedica.ltYesCommercialisedNoNoMicroplateAutomatedManualIgGPlasmaSerumAdditional information: ELISA microplate wells are coated with recombinant SARS-CoV-2 surface spike (S) glycoprotein, which has no transmembrane. During the first stage diluted patient blood samples are incubated in ELISA microplate wells with immobilised recombinant viral protein (antigen) - SARS-CoV-2 surface glycoprotein S. In case of a positive sample, virus-specific antibodies (IgG) will bind with the antigens. Bounded specific IgG Kit for in vitro diagnostic use Catalogue No. Specific antibodies Ig class Substrate Format El-2020-9499 G SARScoronavirus-2 (SARS-CoV-2 S) IgG Antigen-coated microplate wells 96 x 1 (96 wells)2 antibodies are determined using enzyme-labelled antibodies (HRP, horseradish peroxidase) against the human IgG (enzyme conjugate). Horseradish peroxidase catalyses the colour reaction. Depending on the amount of the antibodies in the samples, the solutions of different intensities are evaluated spectrophotometrically - by measuring the optical density2021-05-10 13:04:001418Immuno-AntibodyNoYesELISAOtherEnzyme-linked180LOD1U/mlCalibrationEvaluatedCrossreactivityNot evaluatedFp1AUFn1AUPrecisionEvaluatedAccuracy99.11% IgGReproducibilityNot evaluatedRobustnessNot evaluatedClinical Sensitivity94% IgG1776SARS-CoV-2 Neutralizing Antibody Rapid Test (Colloidal Gold) 44Joinstar Biomedical Technology Co., LtdChinawww.joinstar.cnYesCommercialisedNoNoLateral flowManualIgGPlasmaSerumWhole blood2021-05-10 13:04:001455Immuno-AntibodyYesYesImmunoassayColorimetry15LOD0U/mlCalibrationNot evaluatedCrossreactivityEvaluatedFp0%0/39Fn5.04%7/139PrecisionEvaluatedAccuracy98.5%ReproducibilityEvaluatedClinical Sensitivity94.7%1900LIAISON® SARS-CoV-2 TrimericS IgG (Ref.311510)511DiaSorin S.p.AItalywww.diasorin.com/YesCommercialisedNoNoCartridgeLab-basedIgGPlasmaSerum 2080 BAU/mL) may be automatically diluted using LIAISON® TrimericS IgG Diluent Accessory ([___REF___] 311512) loaded into the ancillary reagent area. The required dilution factor is 1:20. It is the responsibility of the individual laboratory to conduct studies to determine validity of dilutions other than 1:20.]]>2021-05-10 13:18:201576Immuno-AntibodyYesImmunoassayChemiluminescence35LOD1.85AUCalibrationEvaluatedCrossreactivityEvaluatedFpN.A.FnN.A.Accuracy99% IgGReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.7% IgGClinical Specificity99.5% IgGType of antigenanti-trimeric spike protein specific IgG antibodies to SARS-CoV-21881IDK® anti-SARS-CoV-2 IgG ELISA845Immundiagnostik AGGermanywww.immundiagnostik.comYesCommercialisedNoNoMicrotiter plateAutomatedManualIgGPlasmaSerumEberhardt KE et al 2021 medRxiv, 20212021-05-10 13:04:001560Immuno-AntibodyYesELISAQuantitativeEnzyme-linked130LOD0.4%CalibrationNot evaluatedCrossreactivityEvaluatedFp0.9%Fn0%PrecisionEvaluatedAccuracy99.1%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%Clinical Specificity99.1%Type of antigenOther2025Dimension Vista SARS-CoV-2 IgG (CV2G)444Siemens HealthineersGermanywww.siemens-healthineers.comYesCommercialisedNoNoOtherLab-basedOtherIgGOtherPlasmaSerum-2021-05-10 13:04:001703Immuno-AntibodyNoImmunoassaySemiquantitative16LOD600AUCalibrationEvaluatedCrossreactivityEvaluatedPrecisionEvaluatedAccuracyIgGReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity100%@ 14 days after PCR: 100.0% (CI 95%: 96.2%–100.0%)Clinical Specificity100%Clinical specificity: 100.0% (CI 95% : 99.8%–100.0%)Type of antigenOther1875COVID-19 NEUTRALISING Ab RAPID TEST808PRIMA LabSwitzerlandprimahometest.com/en/YesCommercialisedNoNoCassetteNear POC / POCIgGPlasmaSerumVenous whole bloodWhole bloodThe performance of the device to recognize IgG post-Vaccination have been clinically evaluated.2021-05-10 13:04:001556Immuno-AntibodyNoImmunochromatographyQualitativeNeutralization Antibody (NAb)10LOD93.75AUCalibrationEvaluatedCrossreactivityEvaluatedFpPossible cross-interferences were observed: Ad V IgG, Ad V IgM, RF IgG, antinuclear Ab, HCV IgGFnNo hook effect has been observedPrecisionEvaluatedAccuracy96.5% IgG 98% at 35 days, C.I. 95%]]>ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.6% IgGSensitivity after infection 92.6%(sensitivity after vaccination 98.3% at 35 days, C.I. 95%)Clinical Specificity97.4% IgGSpecificity on pre-outbreak samples 97.4% (C.I. 95%)1975COVID-19 IgG Spike Self Test808PRIMA LabSwitzerlandprimahometest.com/en/YesCommercialisedNoNoCassetteManualIgGWhole bloodThe performance of the device to recognize IgG post-Vaccination have been clinically evaluated. The EC mark for self testing is available (approved by Notified Body 0483)2021-05-10 13:04:001651Immuno-AntibodyNoImmunochromatographyQualitativeNeutralization Antibody (NAb)10LOD93.75AUCalibrationEvaluatedCrossreactivityEvaluatedFpPossible cross-interferences were observed: Ad V IgG, Ad V IgM, RF IgG, antinuclear Ab, HCV IgGFnNo hook effect has been observedPrecisionEvaluatedAccuracy96.5% IgG 98% at 35 days, C.I. 95%]]>ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.6% IgGSensitivity after infection 92.6%(sensitivity after vaccination 98.3% at 35 days, C.I. 95%)Clinical Specificity97.4% IgGon pre-outbreak samples 97.4% (C.I. 95%)Type of antigenOther1806COVID-19 IgG Antibody Test Kit (colloidal gold method)779Guangdong Hecin Scientific, Inc.Chinawww.hecin-scientific.cn/YesCommercialisedNoNoCassetteNear POC / POCIgGhttps://www.hecin-scientific.cn/productinfo/362189.html2021-05-10 13:04:001488Immuno-AntibodyImmunoassayColorimetry1944COVID-19 Antibody Rapid Test Kit (IgG)886Chongqing iSIA BIO-Technology Co., LtdChinawww.isiabio.com.cnYesCommercialisedNoNoCassetteNear POC / POCIgGPlasmaSerumWhole bloodN/A2021-05-10 13:04:001620Immuno-AntibodyImmunochromatographyColloidal gold15LOD0.8AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0%Fn0%PrecisionEvaluatedAccuracy98% IgGReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity98% IgGClinical Specificity97% IgGType of antigenOther1803Alphadia805AlphadiaBelgiumwww.alphadia.beYesCommercialisedNoNoDotblotAutomatedIgGSerum2021-05-10 13:04:001482Immuno-AntibodyNoImmunoassaySemiquantitativeMicroarray65LOD5U/mlCalibrationEvaluatedCrossreactivityEvaluatedFp1AUFn0AUPrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99% IgGClinical Specificity99% IgG2024ADVIA Centaur XP/XPT SARS-CoV-2 IgG (sCOVG)444Siemens HealthineersGermanywww.siemens-healthineers.comYesCommercialisedNoNoOtherLab-basedOtherIgGOtherPlasmaSerumGood correlation and strong relationship between Index values and neutralizing antibody titers. Detection: Chemiluminescence2021-05-10 13:04:001702Immuno-AntibodyNoImmunoassayQuantitativeSandwichChemiluminescence58support: Magnetic particlesLOD0.5AUCalibrationEvaluatedCrossreactivityEvaluatedPrecisionEvaluatedAccuracyIgGReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity96.41@ 21 days after PCR: (95% CI: 92.74%–98.54%)Clinical Specificity99.9%(95% CI: 99.64%–99.99%)Type of antigenOther1992AbC-19 Rapid Test913Abingdon Health PlcUnited Kingdomwww.abingdonhealth.com/YesCommercialisedNoNoCassetteLateral flowNear POC / POCIgGWhole bloodRapid diagnostic test cassette2021-05-10 13:04:001668Immuno-AntibodyNoImmunoassayQualitative20LOD0AUCalibrationNot evaluatedCrossreactivityEvaluatedPrecisionEvaluatedAccuracy99.4% IgGReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.03% IgGClinical Specificity99.56% IgGType of antigenOther1574Zhenrui ®COVID-19 Antigen Test Cassette692Shenzhen Zhenrui Biotechnology Co., LtdChinaen.zr-bio.com/en/YesCommercialisedYesNoCassetteLateral flowNear POC / POCAntigenNasal swabSaliva2021-05-10 19:40:141253Immuno-AntigenYesYesImmunoassayQualitative15LOD12AUCalibrationevaluatedCrossreactivityevaluatedPrecisionevaluatedAccuracy96.5%(Antigen)ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity96%AntigenType of antigennucleoprotein1914Zekmed antigen rapid test cassette (colloidal gold)874ZekmedSwitzerlandwww.zekmed.comYesCommercialisedNoNoCassetteManualNear POC / POCAntigenNasal swabSalivaauthorized distributor , Hotzone solutions group .2021-05-10 13:04:001591Immuno-AntigenNoImmunochromatographyQualitativeColorimetryValidity test kit10LOD220000AUCalibrationEvaluatedCrossreactivityEvaluatedFp0%none according to cross reactivity reportFn0%none according to cross reactivity reportPrecisionEvaluatedAccuracy99%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99%Clinical Specificity100%Type of antigenNucleoprotein1214Wondof SARS-CoV-2 Antigen Test (Lateral Flow Method)124Guangzhou Wondfo Biotech Co., LtdChinaen.wondfo.com.cn/YesCommercialisedNoNoLateral flowNear POC / POCAntigen2021-05-10 13:04:00998Immuno-AntigenYesNoImmunoassayQualitativeColloidal gold1312Wondof 2019-nCoV Antigen Test (Lateral Flow Method)124Guangzhou Wondfo Biotech Co., LtdChinaen.wondfo.com.cn/YesCommercialisedNoNoLateral flowNear POC / POCAntigen2021-05-10 13:04:001082Immuno-AntigenYesImmunoassayQualitativeColloidal gold1437Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)124Guangzhou Wondfo Biotech Co., LtdChinaen.wondfo.com.cn/YesCommercialisedYesYesCassetteLateral flowNear POC / POCAntigenOther2021-05-10 20:07:301189Immuno-AntigenYesNoImmunoassayQualitativeFluorescence15LOD850AUCalibrationevaluatedCrossreactivityevaluatedPrecisionevaluatedAccuracysee IFUReproducibilityevaluatedRobustnessevaluatedClinical Sensitivitysee IFU1456WizBiotech862Xiamen Wiz Biotech Co., LtdChinawww.wizbiotech.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabOther2021-05-10 13:18:201208Immuno-AntigenYesYesImmunoassayQualitativeColorimetry15LOD1.7AUCalibrationevaluatedCrossreactivityevaluatedFp0%338 swabs samples prospectively collected,0 swaps samples False positivesFn0.89%338 swabs samples prospectively collected,3 swaps samples False positivesPrecisionevaluatedAccuracy99.11%(Antigen)ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity96.3%(Antigen)Type of antigennucleoprotein1276Willi Fox COVID-19 Antigen rapid test549Willi Fox GmbHSwitzerlandwillifox.com/YesCommercialisedNoNoCassetteNear POC / POCAntigen2021-05-10 13:04:001051Immuno-AntigenYesImmunoassayQualitative15Clinical Sensitivity99.2%Clinical Specificity100%Type of antigennucleoprotein1484Wantai SARS-CoV-2 Ag Rapid Test (FIA)49Beijing Wantai Biological Pharmacy Enterprise Co., LtdChinawww.ystwt.cn/YesCommercialisedYesNoNear POC / POCAntigenNasal swabOther2021-05-10 13:04:001236Immuno-AntigenYesYesImmunoassayQualitativeFluorescence20LOD5U/mlCalibrationEvaluatedCrossreactivityEvaluatedFp96.9%629/649 (CI: 95.29%-98.00%)Fn96.6%168/174 (CI: 92.68%-98.41%)PrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.6%Type of antigennucleoprotein1485Wantai SARS-CoV-2 Ag Rapid Test (colloidal gold)49Beijing Wantai Biological Pharmacy Enterprise Co., LtdChinawww.ystwt.cn/YesCommercialisedNoNoNear POC / POCAntigenNasal swabOther2021-05-10 13:04:001237Immuno-AntigenYesNoImmunoassayQualitativeFluorescence20LOD20AUCalibrationevaluatedCrossreactivityevaluatedFp0.9%99.1% (1036/1045) (CI: 98.37%~99.55%)Fn3.9%96.1% (173/180) (CI: 92.19%~98.10%)PrecisionevaluatedReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity96.1%Type of antigennucleoprotein1096VTRUST COVID-19 Antigen Rapid Test TD-4531588TaiDoc Technology Corp.Taiwan ROCtaidoc.com/YesCommercialisedNoNoLateral flowNear POC / POCAntigenNasopharyngeal swab https://www.testlinecd.com/file/1580/COVID-19_AN_NEW%20(002).pdf?version=202008131535 https://taidoc.com/covid-19-Antigen-rapid-test-td-4531/; https://taidoc.com/wp-content/uploads/2020/08/Covid-19-Antigen-rapid-test.pdf2021-05-10 13:04:00877Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD126TCID50/mlCrossreactivity0% for virus, microorganisms and negatives matrices tested; EvaluatedClinical Sensitivity93.1%Clinical Specificity99.6%Type of antigennucleocapsid recombinant Antigen (NP)1379Vstrip Covid-19 Antigen Rapid Test658Taiwan ROCwww.pbf.com.tw/YesCommercialisedNoNoNear POC / POCAntigenNasal swabOther2021-05-10 13:04:001145Immuno-AntigenYesNoImmunoassayQualitativeColloidal gold10LOD157U/mlFp1.8%Fn8.7%Accuracy96.2%Clinical Sensitivity91.3%Type of antigennucleoprotein1980VivaDiag SARS-CoV-2 Ag Saliva Rapid Test175VivaChek Biotech (Hangzhou) Co., LtdChinawww.vivachek.com/YesCommercialisedNoNoAntigenSalivaVivaDiagTM SARS-CoV-2 Ag Saliva Rapid Test is registered in Netherlands by its notified noby : Lotus NL B.V. This is the content of certificat : On November11, 2020, I received your notification under Article 4, paragraph 1 of the Dutch Decree for in-vitro diagnostics (DIVD), under the company name VivaChek Biotech (Hangzhou) Co., Ltd. with European authorized Lotus NL B.V. to sell the following in-vitro diagnostic products in the European market. The products are registered as in-vitro diagnostics under serial number: VivaDiag SARS-CoV-2 Ag Saliva Rapid Test VCD17 (geen merknaam) (NL-CA002-2020-54216) Best regards, Yujun2021-05-10 13:18:201656Immuno-AntigenImmunoassay15LOD75.5AUCalibrationNot evaluatedCrossreactivityNot evaluatedPrecisionNot evaluatedAccuracy99.5%ReproducibilityNot evaluatedRobustnessNot evaluatedClinical Sensitivity98.26%Clinical Specificity99.99%99.99%)]]>Type of antigenNucleoprotein1246Vivadiag SARS CoV 2 Ag Rapid Test175VivaChek Biotech (Hangzhou) Co., LtdChinawww.vivachek.com/YesCommercialisedYesNoCassetteNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swab https://www.vivachek.com/en/prods/sarscov2-fluA-fluB-rapidtest.html2021-05-10 19:40:141075Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15Type of antigennucleoprotein1200VITROS Immunodiagnostic Products SARS-CoV-2 Antigen356Ortho Clinical DiagnosticsUnited Stateswww.orthoclinicaldiagnostics.com/YesCommercialisedNoNoAutomatedManualAntigenhttps://www.orthoclinicaldiagnostics.com/en-us/home/technical-documents2021-05-10 13:04:00986Immuno-AntigenYesImmunoassayQualitativeChemiluminescenceClinical Sensitivity100%95% CI: 92.0% - 100%1065Veritor System Rapid Detection of SARS-CoV-242Becton DickinsonUnited Stateswww.bd.com/en-usYesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swab2021-05-10 19:36:3149Immuno-AntigenYesYesImmunoassayQualitativeMagnetic Electrochemical15LOD140TCID50/mlCrossreactivity98.4%Crossreactivity93.5%Accuracy99.3%Type of antigenNucleoprotein1324V-CHEK, 2019-nCoV Ag Rapid Test Kit (Immunochromatography)382Guangzhou Decheng Biotechnology Co., LTDChinawww.dochekbio.comYesCommercialisedNoNoNear POC / POCAntigenNasal swab2021-05-10 13:04:001091Immuno-AntigenYesImmunochromatographyQualitative15Rapid diagnostic test Card LOD100%Clinical Sensitivity96.67%(Antigen)Type of antigennucleoprotein1326V-CHEK, 2019-nCoV Ag Rapid Test Kit (Fluorescence Immunochromatographic Assay)382Guangzhou Decheng Biotechnology Co., LTDChinawww.dochekbio.comYesCommercialisedNoNoNear POC / POCAntigenNasal swab2021-05-10 13:04:001095Immuno-AntigenYesYesImmunochromatographyQualitativeFluorescence10LOD90AUClinical Sensitivity95.06%Type of antigennucleoprotein1883V-CHEK, 2019-nCoV Ag Rapid Test Card (Immunochromatography)382Guangzhou Decheng Biotechnology Co., LTDChinawww.dochekbio.comYesCommercialisedNoNoLateral flowNear POC / POCAntigenSaliva2019-nCoV Ag Saliva Rapid Test Card ; The Test Card is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from 2019-nCoV in saliva specimens directly collected from individuals who are suspected of COVID-19 by their healthcare provider within the first 7 days of symptom onset. This Card uses a double-antibody sandwich to detect the antigen presence of novel coronavirus (2019-nCoV) in saliva samples. During detection, the gold labeled anti-2019-nCoV monoclonal antibody in the labeling pad binds to the 2019-nCoV antigen in the sample to form a complex. The reaction complex moves along the nitrocellulose membrane under the action of chromatography. It is then captured by the anti-2019-nCoV monoclonal antibody pre-coated in the detection zone (T) on the nitrocellulose membrane, and finally a red color reaction line is formed in the T zone. If the sample does not contain 2019-nCoV antigen, a red color reaction line cannot be formed in the T zone. Regardless of whether the sample to be tested contains 2019-nCoV antigen, a red reaction line will always form in the quality control area (C).2021-05-10 13:04:001562Immuno-AntigenNoImmunochromatographyQualitative15LOD100%CalibrationEvaluatedCrossreactivityEvaluatedFpA reaction time of less than 15 minutes may lead to a false negative resultFnA reaction time of more than 15 minutes may lead a false positive result.PrecisionEvaluatedAccuracy97.12%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.65%Clinical Specificity98.44%Type of antigenNucleoprotein1325382Guangzhou Decheng Biotechnology Co., LTDChinawww.dochekbio.comYesCommercialisedNoNoCardNear POC / POCAntigenNasal swab2021-05-10 13:04:001092Immuno-AntigenYesYesImmunoassayQualitative15LOD1000Clinical Sensitivity96.67(Antigen);85.42(FLU A);85.34(FLU B)Type of antigennucleoprotein1317V-Chek SARS-CoV-2 Rapid Ag Test (IFA)405SGA MedikalTurkeywww.sgadx.com/YesCommercialisedNoNoNear POC / POCAntigenNasal swab2021-05-10 13:04:00557Immuno-AntigenYesYesImmunoassayQualitativeFluorescence10LOD50AUFp1AUFn1AUAccuracy98.5%Clinical Sensitivity97.5%Type of antigennucleoprotein1357V-Chek SARS-CoV-2 Rapid Ag Test (colloidal gold)405SGA MedikalTurkeywww.sgadx.com/YesCommercialisedNoNoCardNear POC / POCAntigenNasal swab2021-05-10 13:04:001117Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD100AUFp1%Fn1%Accuracy98.40%Clinical Sensitivity96.60%Type of antigennucleoprotein1319V-Chek SARS-CoV-2 Ag Rapid Test Kit (Colloidal Gold)405SGA MedikalTurkeywww.sgadx.com/YesCommercialisedYesNoCassetteNear POC / POCAntigenNasal swab2021-05-10 19:40:14560Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15Fp1%Fn1%Accuracy98.4%Clinical Sensitivity96.6%Type of antigennucleoprotein1314V-CHEK SARS-CoV-2 Ag Rapid Test Kit382Guangzhou Decheng Biotechnology Co., LTDChinawww.dochekbio.comYesCommercialisedNoNoCardNear POC / POCAntigenNasal swab2021-05-10 13:04:001084Immuno-AntigenYesNoImmunoassayQualitative15Clinical Sensitivity96.67%(Antigen)Type of antigennucleoprotein1316V-CHEK 2019-nCoV Ag Rapid Test Kit382Guangzhou Decheng Biotechnology Co., LTDChinawww.dochekbio.comYesCommercialisedNoNoNear POC / POCAntigenNasal swab2021-05-10 13:04:00527Immuno-AntigenYesYesImmunoassayQualitativeFluorescence10Rapid diagnostic test card fluorescence LOD90AUClinical Sensitivity95.06%(Antigen)Type of antigennucleoprotein1318382Guangzhou Decheng Biotechnology Co., LTDChinawww.dochekbio.comYesCommercialisedNoNoNear POC / POCAntigenNasal swab2021-05-10 13:04:001086Immuno-AntigenYesNoImmunoassayQualitative15Rapid diagnostic test Card LOD100AUClinical Sensitivity96.67%[85.42(FLU A);85.34(FLU B)]Type of antigennucleoprotein1170UNICELL-2019-nCoV Ag379SHENZHEN YHLO BIOTECH CO., LtdChinawww.szyhlo.comYesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swabNasopharyngeal swab2021-05-10 13:04:00954Immuno-AntigenYesYesImmunoassayQualitativeFluorescence15LOD160TCID50/mlFp2%Fn3%Accuracy99.03%Clinical Sensitivity97.37%1497Trueline COVID-19 Ag Rapid Test689TP Medicare GmbHGermanywww.tp-medicare.de/YesCommercialisedNoNoCassetteNear POC / POCAntigenNasopharyngeal swab2021-05-10 13:04:001247Immuno-AntigenYesNoImmunoassayQualitative15Fp0%0 of 21Fn2.7%1 of 37Accuracy98.1%Clinical Sensitivity93.8%Clinical Specificity100%Type of antigennucleocapside1722TOYO Covid-19 Ag Test758TurklabTurkeywww.turklab.com.tr/YesCommercialisedNoNoNear POC / POCAntigenNasal swabOther2021-05-10 13:18:201402Immuno-AntigenYesNoImmunoassayQualitative20LOD0AUCalibrationnot evaluatedCrossreactivityevaluatedPrecisionnot evaluatedAccuracy97.57%ReproducibilityevaluatedRobustnessnot evaluatedClinical Sensitivity93.18%Type of antigennucleoprotein1466TODA CORONADIAG Ag681TODA PHARMAFrancehttps://www.todapharma.com/YesCommercialisedYesYesLateral flowNear POC / POCAntigenNasal swab2021-05-10 20:07:301216Immuno-AntigenYesNoImmunoassayQualitative15LOD502.377AUCalibrationNot evaluatedCrossreactivityevaluatedFp0%On 129 negative samples confirmed by RT-PCR, 129 were also negative with our test : 0 false positiveFn1.37%On 73 positive samples confirmed by RT-PCR, 72 were also negative with our test : 1 false negativePrecisionevaluatedAccuracy99.5%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity98.6%Type of antigennucleoprotein2054TODA Autotest Nasal Covid-19681TODA PHARMAFrancehttps://www.todapharma.com/NoCommercialisedNoNoCassetteLateral flowNear POC / POCAntigenAnterior nasal swabNasal swabPlease kindly note that the above mentioned performance rates are based on nasal swab.2021-05-11 09:51:121734Immuno-AntigenNoImmunochromatographyQualitativeSandwich, DoubleExtraction kit15LOD0AUCalibrationEvaluatedCrossreactivityEvaluatedFp3.38%On 59 negative samples confirmed by RT-PCR, 57 were also negative with our test : 2 false positivesFn0%On 34 positive samples confirmed by RT-PCR, 34 were also negative with our test : 0 false negativePrecisionEvaluatedAccuracy97%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94%Clinical Specificity99%Type of antigenNucleoprotein1290Tigsun COVID-19 Antigen Saliva Rapid Test47Beijing Tigsun Diagnostics Co. LtdChinawww.tigsun.com/YesCommercialisedNoNoNear POC / POCAntigenSaliva2021-05-10 13:04:001064Immuno-AntigenYesImmunoassayType of antigenN protein1292Tigsun COVID-19 Antigen Rapid Test47Beijing Tigsun Diagnostics Co. LtdChinawww.tigsun.com/YesCommercialisedNoNoLateral flowNear POC / POCAntigenNasopharyngeal swabOropharyngeal swab2021-05-10 13:04:001065Immuno-AntigenYesImmunoassayQualitativeType of antigenN protein1773The SARS-CoV-2 Antigen Assay Kit (Immunochromatography)792Wuhan Life Origin Biotech Joint Stock Co., Ltd.Chinawww.szybio.comYesCommercialisedNoNoCardLateral flowNear POC / POCAntigenNasal swab2021-05-10 13:04:001452Immuno-AntigenYesYesImmunochromatographyQualitative15LOD0U/mlCalibrationEvaluatedCrossreactivityEvaluatedFp1.71%(6/350),95%CI(0.63%-3.69%)Fn7.33%(11/150),95%CI(3.72%-12.74%)PrecisionEvaluatedReproducibility96.6%(483/500), 95%CI (94.61%-98.01%)RobustnessEvaluatedClinical Sensitivity92.67%(139/150), 95%CI (87.26%-96.28%)1225Test Rapid Covid-19 Antigen (tampon nazofaringian)577DDS DIAGNOSTICRomaniawww.ddsdiagnostic.comYesCommercialisedYesNoCassetteNear POC / POCAntigenNasal swab2021-05-10 19:40:131009Immuno-AntigenYesNoImmunoassayQualitative15Accuracy98.95%Clinical Sensitivity98.77%Clinical Specificity99.03%1226Test Rapid Combo Covid-19/Influenza A+B Antigen (tampon nazofaringian))577DDS DIAGNOSTICRomaniawww.ddsdiagnostic.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swab2021-05-10 13:04:001010Immuno-AntigenYesNoImmunoassayQualitative15Rapid diagnostic test cassette Accuracy98.95%Clinical Sensitivity98.77%Clinical Specificity99.03%1305Test Rapid Combo Covid-19/Influenza A+B Antigen577DDS DIAGNOSTICRomaniawww.ddsdiagnostic.comYesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swab2021-05-10 13:04:001077Immuno-AntigenYesNoImmunoassayQualitative15Fp1AUFn3AUAccuracy99%Clinical Sensitivity98.77%Clinical Specificity99.03%1976Suresign Professional Covid-19 Antigen Rapid Test Cassette (Oral Fluid)905CIGA Healthcare Ltd.United Kingdomwww.cigahealthcare.com/YesCommercialisedNoNoCassetteNear POC / POCAntigenSalivaRegistered with MHRA 06 March 20212021-05-10 13:04:001652Immuno-AntigenNoImmunoassayQualitativeMembrane-based15LOD100AUCalibrationNot evaluatedCrossreactivityEvaluatedFp2%Fn2%PrecisionEvaluatedAccuracy97%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity90.1%Clinical Specificity99.3%Type of antigenNucleoprotein1275SureScreen COVID-19 Antigen Rapid Test Cassette288SureScreen DiagnosticsUnited Kingdomwww.surescreen.com/YesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swabOropharyngeal swab2021-05-10 13:04:001050Immuno-AntigenYesImmunoassayQualitative152052STANDARD Q COVID-19 Ag Test Nasal224SD BIOSENSOR IncSouth Koreahttp://sdbiosensor.com/xe/YesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swabSimilar to SD Biosensor Standard Q COVID-19 Ag Test, but with nasal swab (product code/REF: Q-NCOV-01G; Cat Nr. 09COV31D and 09COV33D)2021-05-11 09:19:101730Immuno-AntigenNoImmunoassayQualitative15LOD146.6AUCalibrationEvaluatedCrossreactivityEvaluatedFp0%Fn2%PrecisionEvaluatedAccuracy99%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97%Clinical Specificity100%Type of antigenNucleoprotein345STANDARD Q COVID-19 Ag Test224SD BIOSENSOR IncSouth Koreahttp://sdbiosensor.com/xe/YesCommercialisedYesYesCassetteNear POC / POCAntigenNasopharyngeal swab2021-05-10 13:04:00672Immuno-AntigenYesNoImmunochromatographyQualitativeMagnetic Electrochemical30LOD1981TCID50/mlCrossreactivityEvaluatedClinical Sensitivity96.52%Clinical Specificity99.68%344STANDARD F COVID-19 Ag FIA224SD BIOSENSOR IncSouth Koreahttp://sdbiosensor.com/xe/YesCommercialisedYesYesCassetteNear POC / POCAntigenNasopharyngeal swab2021-05-10 13:04:00666Immuno-AntigenYesImmunoassayQualitativeFluorescence15Type of antigennucleoprotein 502Sona Nanotech COVID-19 Lateral Flow Assay Lateral flow screening test for S1 domain of SARS-CoV-2 S1 protein301Sona NanotechCanadasonanano.com/YesIn developmentNoNoLateral flowNear POC / POCAntigenNasopharyngeal swab2021-05-10 13:04:00396Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD214TCID50/mlClinical Sensitivity84.6%Clinical Specificity90%1097Sofia SARS Antigen FIA216Quidel CorporationUnited Stateswww.quidel.com/YesCommercialisedYesYesLateral flowNear POC / POCAntigenNasal swabNasopharyngeal swab2021-05-10 13:04:00878Immuno-AntigenYesYesImmunoassayQualitativeFluorescence15LOD113TCID50/mlCalibrationEvaluatedCrossreactivityEvaluatedFp0%Fn3.3%Accuracy99.5%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.7%Clinical Specificity100%Type of antigenNucleoprotein1650SINGUWAY COVID-19 Ag Test604SINGUWAY BIOTECH IncChinawww.singuway.com/english/index.phpYesCommercialisedNoNoCardNear POC / POCAntigenNasal swabOtherSaliva2021-05-10 13:18:201331Immuno-AntigenYesYesImmunoassayQualitativeColorimetry15LOD1.25AUCalibrationevaluatedCrossreactivityevaluatedPrecisionevaluatedAccuracy96%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity92.59%Type of antigennucleoprotein1974Singclean533Hangzhou Singclean Medical Products Co., LtdChinawww.singclean.net/YesCommercialisedNoNoCassetteManualAntigenNasopharyngeal swabBfarm list AT 437/212021-05-10 13:18:201650Immuno-AntibodyNoImmunochromatographyQualitativeSandwichValidity test kit15LOD9.975U/ml[LOD (U/ml)=9.975 x 102 TCID50/mL]CalibrationNot evaluatedCrossreactivityEvaluatedFpThe results of test reagent and control reagent both were 309 negative specimens, there are three spFnThe results of test reagent and control reagent both were 209 positive specimens, there are three spPrecisionNot evaluatedAccuracy98.84%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.56%Clinical Specificity99.03%Type of antigenNucleoprotein2007SieloCovidAg529DyonMed SAGreecedyonmedical.com/en/home/YesCommercialisedNoNoCassetteNear POC / POCAntigenSalivaSputum2021-05-10 13:04:001685Immuno-AntigenNoImmunochromatographyQualitativeSandwich, Double15LOD6AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0AUFn6AUPrecisionEvaluatedAccuracy98%(Antigen)ReproducibilityNot evaluatedRobustnessNot evaluatedClinical Sensitivity95%(Antigen)Clinical Specificity99%(Antigen)Type of antigenNucleoprotein1114SGTi-flex COVID-19 Ag261Sugentech, IncSouth Koreasugentech.com/YesCommercialisedYesNoCassetteNear POC / POCAntigenNasopharyngeal swabOropharyngeal swab14 days from symptom onset to blood collectionMade in Taiwan ]]>2021-05-10 19:40:131019Immuno-AntigenYesNoImmunoassayQualitativeMagnetic Electrochemical20Clinical Sensitivity100%Clinical Specificity100%2003SG Diagnostics COVID-19 Antigen Rapid Test Kit (Colloidal Gold-Based)921SG Diagnostics Pte LtdSingaporehttps://www.sgdiagnostics.comYesCommercialisedNoNoCassetteLateral flowNear POC / POCAntigenDeep (cough) sputumNasal swabNasopharyngeal swabOropharyngeal swabSalivaSG Diagnostics COVID-19 Antigen Rapid Test Kit showed no cross-reactivity with the following potentially cross-reactive common organisms - Human coronavirus (229E, HKU1, OC43 and NL63), Middle East respiratory syndrome (MERS) coronavirus, Adenovirus, Enterovirus, Influenza A (H1N1 and H3N2) and B viruses, Avian influenza virus, Parainfluenza type 1-4, Measles virus, Human metapneumovirus, Mumps virus, Rhinovirus, Epstein-Barr virus, Respiratory syncytial virus, Staphylococcus aureus, Streptococcus pneumoniae, Staphylococcus epidermidis, Mycobacterium tuberculosis, Legionella pneumophila, Haemophilus influenza, Streptococcus pyogenes, Chlamydia pneumoniae, Mycoplasma pneumoniae, Candida albicans, organisms that make up normal respiratory flora, and organism(s) that causes parapertussis and pneumocystis.2021-05-10 13:04:001680Immuno-AntigenYesNoImmunochromatographyQualitativeMembrane-basedColloidal gold10LOD75AUCalibrationNot evaluatedCrossreactivityEvaluatedPrecisionEvaluatedAccuracy98.99%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity97.57%Clinical Specificity99.29%Type of antigenNucleoprotein1917Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV-2) Antigen Assay Kit by Colloidal Gold Method168Maccura Biotechnology Co., LtdChinawww.maccura.com/enYesCommercialisedNoNoCardCassetteManualNear POC / POCAntigenNasal swabNasopharyngeal swab/2021-05-10 13:18:201849Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)Antigen Detection Kit (Colloidal Gold-Based)184Nanjing Vazyme Medical Technology Co., LtdChinawww.vazymebiotech.com/YesCommercialisedNoNoManualAntigenNasal swabNasopharyngeal swabSalivahttp://www.vazymebiotech.com/COVID.html2021-05-10 13:04:001529Immuno-AntigenNoImmunoassayQualitativeSandwich, DoubleOther10LOD5050AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0%Fn2%PrecisionEvaluatedAccuracy98.99%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.57%Clinical Specificity99.29%Type of antigenNucleoprotein1272Sensitest Joysbio Antigen Rapid Test for Covid-19638SensitestNetherlandswww.sensitest.com/index.php?p=sensitest-covid-corona-Antigen-testYesCommercialisedNoNoNear POC / POCAntigenNasal swab2021-05-10 13:04:001048Immuno-AntigenYesImmunoassayQualitative15Clinical Specificity99%1818Senova Greenlight825Senova Gesellschaft für Biowissenschaft und TechnikGermanywww.senova.deYesCommercialisedNoNoLateral flowNear POC / POCSemi-automatedAntigenNasopharyngeal swabThe GreenLight SARS-CoV-2 antigen test is an in-vitro-diagnostic for the detection of SARS-CoV-2 antigen in human nasopharyngeal swab specimens from individuals who meet COVID-19 clinical or epidemiological criteria. GreenLight SARS-CoV-2 antigen test is for professional use only and is intended to be used as an aid in the diagnosis of SARS-CoV-2 infection. Results must be interpreted together with clinical information i.e. symptoms, suspect of infection, clinical methods and other in-vitro diagnostic procedures. The product may be used in any medical laboratory or non-laboratory environment that meets the requirements specified in the Instructions for Use and local regulations. The test provides primarily the test results and optional additional information compiled in a report sent to the smart-phone of the user or a smartphone within a work group.2021-05-10 13:04:001496Immuno-AntigenNoImmunochromatographyQuantitativeColorimetryVisualisation system12LOD502AUCalibrationEvaluatedCrossreactivityEvaluatedFp3.9%4 FP out of 102 PCR negativesFn5.2%2 negatives out of 38 PCR positivesPrecisionEvaluatedAccuracy98%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90%(CI95% :80.7 – 99)Clinical Specificity98%(CI95%: 95.3 – 100)Type of antigenN Protein1590Screentest Covid-19+FLU A/B701SCREEN ITALIA S.r.l.Italywww.screenitalia.itYesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swab2021-05-10 13:04:001270Immuno-AntigenYesNoImmunoassayQualitative15Accuracy98%ReproducibilityevaluatedClinical Sensitivity96.4%Clinical Specificity99.2%1847SCREEN TEST COVID-19 SALIVA701SCREEN ITALIA S.r.l.Italywww.screenitalia.itYesCommercialisedNoNoCassetteManualAntigenSalivaSputum* LOD: According to the study shown above, the lowest concentration that still led to a 100% detection rate was 100 TCID50/mL of inactivated SARS-COV-2 (Swab). Conclusion: Minimal detection limits of COVID-19 Antigen Rapid Test is 100pg/ml for recombine COVID-19 protein and 100TCID50/mL for inactivated SARS-COV-2.2021-05-10 13:18:201527Immuno-AntigenYesNoImmunochromatographyQualitativeOtherOther15LOD0AU0CalibrationNot evaluatedCrossreactivityEvaluatedFp2.15%2 on 93Fn0.96%10 on 313PrecisionEvaluatedAccuracy97%(95% CI*: 94.9%~98.5%)ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity90.1%(95% CI*:82.5%~95.1%)Clinical Specificity99.3%(95% CI*: 97.7%~99.9%)Type of antigenNucleoprotein1681SCREEN TEST COVID-19 AG - COVID-19 ANTIGEN RAPID TEST701SCREEN ITALIA S.r.l.Italywww.screenitalia.itYesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swabOther2021-05-10 13:18:201360Immuno-AntigenYesNoImmunoassayQualitative15LOD50AUCalibrationnot evaluatedCrossreactivityevaluatedFp1.23%1 on 81Fn2.44%3 on 123PrecisionevaluatedAccuracy98%(95%CI: 95.1%-99.5%)Reproducibilitynot evaluatedRobustnessnot evaluatedClinical Sensitivity96.4%(95%CI: 89.8%- 99.2%)Type of antigennucleoprotein1421SCoV-2 Ag Detect Rapid Test139InBios InternationalUnited Statesinbios.com/NoIn developmentNoNoLateral flowNear POC / POCAntigenNasal swab2021-05-10 13:04:001181Immuno-AntigenYesImmunochromatographyQualitative30Type of antigennucleoprotein1201ScheBo SARS CoV-2 Quick Antigen359ScheBo Biotech AGGermanywww.schebo.de/YesCommercialisedNoNoCassetteNear POC / POCAntigenNasopharyngeal swabOropharyngeal swabSerum2021-05-10 13:04:00987Immuno-AntigenYesNoImmunochromatographyQualitativeFluorescence15LOD3.5U/mlCalibrationEvaluatedCrossreactivityEvaluatedFp1.12%6/534Fn3.44%4/116PrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.77%Clinical Sensitivity96.6%(Ct 30)Type of antigenNucleoprotein2021SARS-oV- Antigen Rapid Test kit (Saliva Test)929Ningbo Home Test Bio-echnology Co.,Ltd.Chinahttp://www.nbhtbio.cn/List-how1-d-01.htmlYesCommercialisedNoNoCartridgeLateral flowStripNear POC / POCAntigenSalivaThe product has passed the PEI review.2021-05-10 13:04:001699Immuno-AntigenNoChromatographyQualitativeOther15LOD500AUCalibrationNot evaluatedCrossreactivityEvaluatedFp4AUFn5AUPrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity97.92%Clinical Specificity98.34%Type of antigenNucleoprotein1320SARS-CoV2 Antigen Rapid Test410Monocent, IncUnited Stateswww.monocent.comYesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swab2021-05-10 13:04:00564Immuno-AntigenYesNoImmunoassayQualitativeColorimetry20LODAU1FpAU0Fn%1Accuracy99.25Clinical Sensitivity98.25%Type of antigennucleoprotein1473SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae Antigen Combo Rapid Test659CITEST DIAGNOSTICS INCCanadawww.citestdiagnostics.com/YesCommercialisedNoNoNear POC / POCAntigenNasal swab no info in company website2021-05-10 13:04:001222Immuno-AntigenYesNoImmunoassayQualitative15Rapid diagnostic test LOD0AU0CalibrationNot evaluatedCrossreactivityevaluatedFp0.8%(0.9% Influenza A; 0.9% Influenza B; 3.8% RSV; 1.4% Adenovirus; 2% M.pneumoniae)Fn3.6%(5% Influenza A; 7.1% Influenza B; 5.7% RSV; 3.1% Adenovirus;8.2% M.pneumoniae)PrecisionevaluatedAccuracy98%(98.4 Influenza A; 98.1influenza B; 95.9 RSV; 98.4 Adenovirus; 97 M.pneumoniae)ReproducibilityevaluatedRobustnessnot evaluatedClinical Sensitivity96.4%(95 Influenza A; 92.9% Influenza B; 94.3 RSV; 96.9 Adenovirus; 91.8 M.pneumoniae)Type of antigennucleoprotein1472SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen659CITEST DIAGNOSTICS INCCanadawww.citestdiagnostics.com/YesCommercialisedNoNoNear POC / POCAntigenNasal swab2021-05-10 13:04:001221Immuno-AntigenYesNoImmunoassayQualitative15LOD0CalibrationNot evaluatedCrossreactivityevaluatedFp0.8%(S0.9% Influenza A; 0.9% Influenza B; 3.8% RSV; 1.4% Adenovirus)Fn3.6%(5% Influenza A; 7.1% Influenza B; 5.7% RSV; 3.1% Adenovirus)PrecisionevaluatedAccuracy98%(98.4 Influenza A; 98.1 Influenza B; 95.9 RSV; 98.4 Adenovirus)ReproducibilityevaluatedRobustnessnot evaluatedClinical Sensitivity96.4%(95 Influenza A; 92.9 Influenza B; 94.3 RSV; 96.9 Adenovirus)1474SARS-CoV-2/Influenza A+B/RSV Antigen Combo Rapid Test659CITEST DIAGNOSTICS INCCanadawww.citestdiagnostics.com/YesCommercialisedNoNoNear POC / POCAntigenNasal swab no info in company website2021-05-10 13:04:001223Immuno-AntigenYesNoImmunoassayQualitative15Rapid diagnostic test LOD0AUCalibrationNot evaluatedCrossreactivityevaluatedFp0.8%(0.9% Influenza A; 0.9% Influenza B; 3.8% RSV)Fn3.6%(5% Influenza A; 7.1% Influenza B; 5.7% RSV)PrecisionevaluatedAccuracy98%(98.4 Influenza A; 98.1 Influenza B; 95.9 RSV)ReproducibilityevaluatedRobustnessnot evaluatedClinical Sensitivity96.4%(95 Influenza A; 92.9 Influenza B; 94.3 RSV)Type of antigennucleoprotein177744Joinstar Biomedical Technology Co., LtdChinawww.joinstar.cnYesCommercialisedNoNoLateral flowManualAntigenNasal swab2021-05-10 13:04:001456Immuno-AntigenYesNoImmunochromatographyQualitativeColorimetry15LOD0U/mlCalibrationNot EvaluatedCrossreactivityEvaluatedFp3%Fn1%PrecisionEvaluatedAccuracy98.9%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.1%1814824Shenzhen Kisshealth Biotechnology Co., LtdChinaen.kisshealth.cn/YesCommercialisedNoNoLab-basedAntigenNasal swabNasopharyngeal swabOropharyngeal swabhttp://en.kisshealth.cn/upload/P96592cfb0b59410ca1d6e95dfc519da8.pdf2021-05-10 13:04:001492Immuno-AntigenImmunochromatographyColorimetry15Accuracy: 97.99%(FluA),97.75%(FluB). Senstitivity: 97.73%(FluA),97.25%(FluB). Specificity: 98.27%(FluA),98.27%(FluB)LOD1AUCalibrationNot evaluatedCrossreactivityEvaluatedFp1%Fn0%PrecisionEvaluatedAccuracy99.34%ReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity99.42%Clinical Specificity99.26%1789344Hangzhou Realy Tech Co., LtdChinawww.realytech.com/YesCommercialisedNoNoCassetteNear POC / POCAntigenNasopharyngeal swab2021-05-10 13:04:001468Immuno-AntigenNoImmunochromatographyQualitativeColorimetrySample collection device20LOD0AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0%Fn3.83%PrecisionEvaluatedAccuracy98.79%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.17%Clinical Specificity99.9%1228SARS-CoV-2 Spike Protein Test Kit (Fluorescence Immunoassay)563Shenzhen Microprofit Biotech Co., LtdChinawww.microprofit-bio.com/YesCommercialisedNoNoAntigen2021-05-10 13:04:001013Immuno-AntigenImmunoassayImmunoAssay-Antigen 1178SARS-CoV-2 Spike Protein Test Kit (Colloidal Gold Chromatographic Immunoassay)563Shenzhen Microprofit Biotech Co., LtdChinawww.microprofit-bio.com/YesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swab http://www.wellbioscience.com/products/detail/1fBC58b58H8G5607.html 2021-05-10 13:04:00960Immuno-AntigenYesImmunoassayQualitativeColorimetry1946SARS-COV-2 rapid antigen test (Swab)126Hangzhou AllTest Biotech Co., LtdChinawww.alltests.com.cn/YesCommercialisedNoNoCassetteLateral flowNear POC / POCAntigenNasal swabThe SARS-CoV-2 Antigen Rapid Test (Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 Nucleocapsid protein antigens in swab specimen from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2 Nucleocapsid protein Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with SARS-CoV-2.2021-05-10 13:18:201622Immuno-AntigenImmunochromatographyQualitative15LOD100AUCalibrationEvaluatedCrossreactivityEvaluatedFp0.006AUFn0.066AUPrecisionEvaluatedAccuracy97.9%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.4%Clinical Specificity99.4%Type of antigenNucleoprotein12SARS-CoV-2 Nucleocapsid Protein Rapid Detection Kit9Academia SinicaTaiwan ROCwww.sinica.edu.tw/enNoIn developmentNoNoNear POC / POCAntigen2021-05-10 13:04:0012Immuno-AntigenYesImmunoassayRapid diagnostic test Type of antigenNucleocapsid1961SARS-CoV-2 MONLABTEST897MONLAB, SLSpainwww.monlab.comYesCommercialisedNoNoCassetteManualAntigenNasopharyngeal swabLoD: Detection limit value (typical) of SARS-CoV-2 is 1.00 ng/mL of SARS-CoV-2 recombinant protein or 1x103 TCID50/mL of 2019nCoV/USA-WA1/20202021-05-10 13:04:001637Immuno-AntigenNoImmunoassayQualitativeMembrane-based10LOD1ng/mLCalibrationNot evaluatedCrossreactivityEvaluatedFp0.4%Fn7.1%PrecisionEvaluatedAccuracy98%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.9%Clinical Specificity99.6%Type of antigenNucleoprotein1973SARS-CoV-2 antigen Test Kit (LFIA)903Jiangsu Medomics medical technology Co.,LtdChinawww.medomics-dx.com/YesCommercialisedNoNoLateral flowLab-basedManualNear POC / POCAntigenAnterior nasal swabNasopharyngeal swabThroat swabMedomics SARS-CoV-2 antigen Test Kit (LFIA) is used to qualitatively detect SARS-CoV-2 in human samples in vitro. Medomics SARS-CoV-2 antigen Test Kit (LFIA) detects the SARS-CoV-2 nucleocapsid antigens with colloidal gold immunochromatography using a double antibody sandwich assay.2021-05-10 13:04:001649Immuno-AntigenYesImmunochromatographyQualitativeMembrane-basedOther15LOD10AUCalibrationNot evaluatedCrossreactivityEvaluatedPrecisionEvaluatedAccuracy98.88%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity97.73%Clinical Specificity99.51%Type of antigenOther2006SARS-CoV-2 antigen Test Kit (LFIA)923Jiangsu Medomics medical technology Co.,Ltd.Chinahttp://www.medomics-dx.com/YesCommercialisedNoNoCardLateral flowNear POC / POCAntigenAnterior nasal swabNasopharyngeal swabThroat swabMedomics SARS-CoV-2 antigen Test Kit(LFIA) is used to qualitatively detect SARS-CoV-2 in human samples in vitro. Medomics SARS-CoV-2 antigen Test Kit(LFIA) detects the SARS-CoV-2 nucleocapsid antigens with colloidal gold immunochromatography using a double antibody sandwich assay.2021-05-10 13:04:001684Immuno-AntigenNoImmunochromatographyQualitativeSandwichColloidal goldValidity test kit152 nucleocapsid antigens LOD10AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0.49%Fn2.27%PrecisionEvaluatedAccuracy98.88%ReproducibilityNot evaluatedRobustnessNot evaluatedClinical Sensitivity97.73%Clinical Specificity99.51%Type of antigenNucleoprotein1813SARS-CoV-2 Antigen Test Kit (GICA)824Shenzhen Kisshealth Biotechnology Co., LtdChinaen.kisshealth.cn/YesCommercialisedNoNoManualAntigenNasal swabNasopharyngeal swabSaliva1. This test is for in vitro diagnostic use only. 2. This test is a qualitative test and cannot determine the specific content of antigen in the sample. 3. Test performance depends on the amount of virus (antigen) in the sample and may or may not correlate with viral culture results performed on the same sample. 4. Test results must be evaluated in conjunction with other clinical data available to the physician. 5. This test cannot distinguish between asymptomatic carriers and infected persons of the SARS-CoV-2. 6. A false negative result may be obtained if the concentration of the viral antigen in the nasopharyngeal and nasal swab is below the sensitivity. 7. Negative results should be treated as presumptive and confirmed with an approved molecular assay. 8.The Spike protein antigen of SARS-CoV-2 can’t be identified.2021-05-10 13:04:001510Immuno-AntigenImmunochromatographyColorimetry1968SARS-CoV-2 Antigen Test Kit (Fluorescence Immunoassay)563Shenzhen Microprofit Biotech Co., LtdChinawww.microprofit-bio.com/YesCommercialisedNoNoCassetteLateral flowManualAntigenNasal swabNasopharyngeal swabOropharyngeal swabwww.microprofit-bio.com2021-05-10 13:18:201644Immuno-AntibodyYesImmunochromatographyFluorescence15LOD25AUCalibrationEvaluatedCrossreactivityEvaluatedFp0%Fn4.3%PrecisionEvaluatedAccuracy97.6%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.65%Clinical Specificity100%Clinical specificity = 300/300 = 100% (95%CI:98.78% ~100%)2012SARS-CoV-2 Antigen Test Kit (Colloidal Gold)472Genrui Biotech IncChinawww.genrui-bio.com/YesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabEvaluation PEI: Positive2021-05-10 13:18:201690Immuno-AntigenNoImmunochromatographyQualitativeColloidal gold15LOD180AUCalibrationEvaluatedCrossreactivityEvaluatedFp0.98%Fn8.85%PrecisionEvaluatedAccuracy94.88%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity91.15%Clinical Specificity99.02%Type of antigenNucleoprotein1871SARS-CoV-2 Antigen Test Kit (Colloidal Gold)859Foregene Co., LtdChinawww.foregene.comYesCommercialisedNoNoCassetteManualAntigenNasal swabNasopharyngeal swabSalivaEC Representative SUNGO Europe B.V. Address: Olympisch Stadion 24, 1076DE Amsterdam, Netherlands2021-05-10 13:04:001553Immuno-AntigenNoOtherQualitativeColorimetryOther15LOD150AUCalibrationEvaluatedCrossreactivityEvaluatedFp100%Fn95%PrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity100%Clinical Specificity95%Type of antigenNucleoprotein1888SARS-CoV-2 Antigen Test Kit (Colloidal Gold)863Wuhan HealthCare Biotechnology Co., Ltd.Chinawww.health-carebiotech.comYesCommercialisedNoNoAntigenNasal swabNasopharyngeal swabSalivafor more information, please contact cs@healthcare-bio.com2021-05-10 13:04:002068SARS-CoV-2 Antigen Test Kit (colloidal gold method) nasal swab955BIOTEKE CORPORATION (WUXI) CO., LTDChinahttps://www.bioteke.cn/YesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swabhttps://www.bioteke.cn/2021-05-17 11:19:591748Immuno-AntigenNoImmunoassayQualitativeSandwich, DoubleColloidal goldValidity test kit15LOD575AUCalibrationEvaluatedCrossreactivityEvaluatedFp0.61%Fn4.23%PrecisionEvaluatedAccuracy95.77(95%CI: 92.87%～97.73%)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity91.61(95%CI: 85.80%～95.59%)Clinical Specificity99.39(95%CI: 96.65%～99.98%)Type of antigenNucleoprotein1487SARS-CoV-2 Antigen Test Kit (colloidal gold method)848Bioteke Taizhou Biotechnology Co., LtdChinawww.bioteke.cn/YesCommercialisedNoNoNear POC / POCAntigenNasal swabSaliva2021-05-10 13:18:201230Immuno-AntigenYesNoImmunoassayQualitativeColloidal gold15Rapid diagnostic test colloidal gold LOD175CalibrationevaluatedCrossreactivityevaluatedFp2Fn3PrecisionevaluatedAccuracy98.58%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity95.95%Type of antigennucleoprotein2058SARS-CoV-2 Antigen Test Kit (colloidal gold method)949Hangzhou Bioer Technology Co., Ltd.Chinahttp://www.bioer.com.cn/en/YesCommercialisedNoNoCassetteManualAntigenNasopharyngeal swabOropharyngeal swabhttp://www.bioer.com.cn/en/2021-05-17 10:09:571738Immuno-AntigenNoImmunochromatographyQualitativeSandwichColloidal goldValidity test kit15LOD1.75AUCalibrationEvaluatedCrossreactivityEvaluatedFp1%Fn4.6%PrecisionEvaluatedAccuracy98.2%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity95.4%Clinical Specificity99%Type of antigenNucleoprotein2067SARS-CoV-2 Antigen Test Kit (colloidal gold method)955BIOTEKE CORPORATION (WUXI) CO., LTDChinahttps://www.bioteke.cn/YesCommercialisedNoNoCassetteNear POC / POCAntigenNasopharyngeal swabOropharyngeal swabhttps://www.bioteke.cn/2021-05-17 11:08:461747Immuno-AntigenNoImmunoassayQualitativeSandwich, DoubleColloidal goldValidity test kit15LOD175AUCalibrationEvaluatedCrossreactivityEvaluatedFp0.72%Fn3.51%PrecisionEvaluatedAccuracy98.47%(95%CI: 96.70%～99.44%)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.49(95%CI: 91.26%～99.04%)Clinical Specificity99.28(95%CI: 97.43%～99.91%)Type of antigenNucleoprotein1967SARS-CoV-2 Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay)563Shenzhen Microprofit Biotech Co., LtdChinawww.microprofit-bio.com/YesCommercialisedNoNoCassetteLateral flowManualAntigenNasal swabNasopharyngeal swabOropharyngeal swabwww.microprofit-bio.com2021-05-10 13:18:201643Immuno-AntibodyImmunochromatographyColloidal gold15LOD49AUCalibrationEvaluatedCrossreactivityEvaluatedFp0%Fn7%PrecisionEvaluatedAccuracy96.11%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.93%Clinical Specificity100%Clinical specificity = 300/300 = 100% (95%CI:98.78% ~100%)Type of antigenNucleoprotein1759SARS-CoV-2 Antigen Test Kit786Hubei Jinjian Biology Co., LtdChinaen.jinjianbio.com/YesCommercialisedNoNoCassetteAutomatedAntigenNasal swab2021-05-10 13:04:001437Immuno-AntigenYesYesImmunochromatographyQualitativeColorimetry15LOD115U/mlCalibrationNot EvaluatedCrossreactivityEvaluatedFp1%1 out of 100Fn1.35%2 out of 148PrecisionEvaluatedAccuracy98.8%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.02%Type of antigenNucleoprotein2017SARS-CoV-2 Antigen Test Kit926Shenzhen Ultra-Diagnostics Biotec.Co.,LtdChinawww.ud-bio.comYesCommercialisedNoNoCardCassetteLateral flowManualNear POC / POCAntigenNasal swabNasopharyngeal swabSaliva1. For in vitro diagnostic use only. 2. Proper specimen collection storage and transit are critical to the performance of this test. 3. Use only once. 4. Do not touch the reaction area of test strip. 5. Do not use test kit beyond the expiration date. 6. Do not use the kit if the pouch is punctured or sealed not well. 7. Testing should be applied by professionally trained staff working in certified laboratories or clinics. 8. The test result should be interpreted by the physician along with clinical findings and other laboratory test results. 9. Dispose of test cards and items in contact with samples as medical waste after use. 10.Do not freeze.2021-05-10 13:04:001695Immuno-AntigenNoImmunochromatographyQualitativeMembrane-basedValidity test kit15LOD625AUCalibrationNot evaluatedCrossreactivityEvaluatedFpReading result after 30 minutesFnthe concentration of virus is below LODPrecisionEvaluatedAccuracy97.35%(Nasal),97.94(Nasopharyngeal),97.36(Saliva)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.33%(Nasal),95.48(Nasopharyngeal),94.83(Saliva)Clinical Specificity99.16%(Nasal),99.61(Nasopharyngeal),99.33(Saliva)Type of antigenNucleoprotein1644SARS-CoV-2 Antigen Test Cassette (Nasal Swab Specimen)753Jiangsu Mole Bioscience CO., LTDChinaen.molechina.com/YesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swab2021-05-10 13:18:201324Immuno-AntigenYesNoImmunoassayQualitativeColloidal gold15LOD100AUCalibrationevaluatedCrossreactivityevaluatedFp0.08%Fn0.6%PrecisionevaluatedAccuracy99%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity100%Type of antigennucleoprotein1146SARS-CoV-2 Antigen Test252LumiraDXUnited Kingdomwww.lumiradx.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabhttps://www.lumiradx.com/uk-en/what-we-do/diagnostics/test-technology/Antigen-test2021-05-10 13:04:00315Immuno-AntigenYesYesImmunoassayQualitativeImmunofluorescence12LOD32TCID50/mlCrossreactivityno crossreactivity with Human coronavirus 229E; Human coronavirus OC43; Human coronavirus NL63; MERS coronavirus; Adenovirus (e.g. C1 Ad. 71); Human Metapneumovirus (hMPV); Parainfluenza virus Type 1; Parainfluenza virus Type 2; Parainfluenza virus Type Accuracy96.9%Clinical Sensitivity97.6%Clinical Specificity96.6Type of antigennucleocapsid protein (N-protein)1909SARS-CoV-2 Antigen Rapid Test Strip565Acon Biotech (Hangzhou) Co., LtdChinawww.aconbio.com/YesCommercialisedNoNoLateral flowStripNear POC / POCAntigenNasal swabNasopharyngeal swabN.A.2021-05-10 13:18:201584Immuno-AntigenImmunochromatographyQualitativeMembrane-basedLOD160AUCrossreactivityEvaluatedFp0.24(1 out of 410)Fn2.59(3 out of 116)PrecisionEvaluatedAccuracy99.2%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.4%Clinical Specificity99.8%Type of antigenNucleoprotein1907SARS-CoV-2 Antigen Rapid Test Strip683ACON Laboratories, IncUnited Stateswww.aconlabs.comYesCommercialisedNoNoLateral flowStripNear POC / POCAntigenNasal swabNasopharyngeal swabN.A.2021-05-10 13:18:201582Immuno-AntigenNoImmunochromatographyQualitativeMembrane-basedN.A.15LOD160CalibrationNot evaluatedCrossreactivityEvaluatedFp0.24%(1 out of 410)Fn2.59%(3 out of 116)PrecisionEvaluatedAccuracy99.2%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.4%Clinical Specificity99.8%Type of antigenNucleoprotein1766SARS-CoV-2 Antigen Rapid Test Kit - Saliva (Colloidal Gold)516JOYSBIO (Tianjin) Biotechnology Co., LtdChinaen.joysbio.com/YesCommercialisedNoNoLateral flowNear POC / POCAntigenSaliva2021-05-10 13:18:201445Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD320U/mlCalibrationEvaluatedCrossreactivityEvaluatedFp0%0 out of 260 RT-PCR negative specimensFn4.9%5 out of 102 RT-PCR positive specimensPrecisionEvaluatedAccuracy98.62%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.1%Type of antigenNucleoprotein1286SARS-CoV-2 Antigen Rapid Test Kit (Fluorescence Immunochromatography)53BIOHIT HealthCare (Hefei) Co., LtdChinawww.biohit.cnYesCommercialisedNoNoNear POC / POCAntigenSerum2021-05-10 13:04:001060Immuno-AntigenYesImmunochromatographyQualitativeFluorescence15LOD20TCID50/mlLOD3.5pgper mlClinical Sensitivity96.77%Clinical Specificity98.9%1764SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold)516JOYSBIO (Tianjin) Biotechnology Co., LtdChinaen.joysbio.com/YesCommercialisedYesNoLateral flowNear POC / POCAntigenNasal swab2021-05-11 09:28:101442Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD160AUAnalytical Sensitivity98.13%Crossreactivity0AUFp3AUFn2AUAccuracy98.98%1595SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold)704Genesprint Group LimitedHong Kong S.A.Rwww.gsprint.coYesCommercialisedNoNoNear POC / POCAntigenNasal swab2021-05-10 13:04:001275Immuno-AntigenYesNoImmunoassayQualitativeColloidal gold5Rapid diagnostic test cassette colloidal gold LOD103AUCalibrationevaluatedCrossreactivityevaluatedFp5%(Less than 5%)Fn5%(Less than 5%)PrecisionevaluatedAccuracy99%ReproducibilityevaluatedRobustnessnot evaluatedClinical Sensitivity98.96%Type of antigennucleoprotein1276Immuno-AntigenYesNoImmunoassayQualitativeColloidal gold5Rapid diagnostic test cassette colloidal gold LOD103AUCalibrationevaluatedCrossreactivityevaluatedFp5%(Less than 5%)Fn5%(Less than 5%)PrecisionevaluatedAccuracy99%ReproducibilityevaluatedRobustnessnot evaluatedClinical Sensitivity98.96%Type of antigennucleoprotein1655SARS-CoV-2 Antigen Rapid Test Kit (Colloidal gold Immunoassay)376Wuhan UNscience Biotechnology Co., LtdChinawww.uni-science.comYesCommercialisedNoNoCassetteManualAntigenNasal swabOther2021-05-10 13:18:201334Immuno-AntigenNoImmunoassayQualitativeColorimetry10LOD0.001AUCalibrationevaluatedCrossreactivityevaluatedFp0.43%Fn3.67%PrecisionevaluatedAccuracy98.53%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity96.33%Type of antigennucleoprotein1841SARS-CoV-2 Antigen Rapid Test Kit (Anterior Nasal624Zhejiang Anji Saianfu Biotech Co., LtdChinawww.seinofy.comYesCommercialisedNoNoCassetteManualAntigenAnterior nasal swabvisit our website2021-05-10 13:18:201518Immuno-AntigenNoImmunoassayQualitativeSandwich, Double15LOD5.8AUCalibrationEvaluatedCrossreactivityEvaluatedFp1.8%Fn0.9%PrecisionEvaluatedAccuracy98.8%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.2%Clinical Specificity99.1%Type of antigenNucleoprotein1331SARS-CoV-2 Antigen Rapid Test Kit319Beijing Lepu Medical Technology Co., LtdChinaen.lepumedical.com/YesCommercialisedYesYesCardNear POC / POCAntigenNasal swab2021-05-10 13:04:001100Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15Accuracy96.67%Clinical Sensitivity92%1266SARS-CoV-2 Antigen Rapid Test Kit346Labnovation Technologies IncChinawww.labnovation.com/YesCommercialisedYesNoNear POC / POCAntigenNasopharyngeal swabOropharyngeal swab2021-05-10 19:40:141040Immuno-AntigenYesImmunoassayQualitativeColloidal gold15Type of antigennucleocapsid protein1600SARS-CoV-2 Antigen Rapid Test Kit376Wuhan UNscience Biotechnology Co., LtdChinawww.uni-science.comNoCommercialisedNoNoCassetteNear POC / POCAntigenNasopharyngeal swab2021-05-10 13:18:201281Immuno-AntigenYesNoImmunoassayQualitativeColloidal gold101465SARS-CoV-2 Antigen Rapid Test Kit677Triplex International Biosciences Co., LtdChinawww.tibchina.com/index_en.aspxYesCommercialisedNoNoNear POC / POCAntigenNasal swab2021-05-10 13:04:001207Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD0AUCalibrationNot evaluatedCrossreactivityevaluatedFp0%Fn1.49%PrecisionevaluatedAccuracy99.52%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity98.51Type of antigennucleoprotein1902SARS-COV-2 Antigen Rapid Test Device719Zhuhai Encode Medical Engineering Co., LtdChinawww.encode.com.cn/YesCommercialisedNoNoCassetteManualAntigenNasal swabNasopharyngeal swabSalivaThroat swabSpecimens: Nasal swabs/ Throat swabs/Anterior nasal swabs/Saliva specimen2021-05-10 13:18:201578Immuno-AntigenImmunochromatographyQualitativeColorimetry20LOD530AUCalibrationEvaluatedCrossreactivityEvaluatedFp0%Fn4AUPrecisionEvaluatedAccuracy97.7%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.1%Clinical Specificity100%Type of antigenNucleoprotein1780SARS-Cov-2 Antigen Rapid Test Cassette (swab)381Spring Healthcare Services AGSwitzerlandwww.springhealthcare.org/YesCommercialisedNoNoCardLateral flowNear POC / POCAntigenNasal swabNasopharyngeal swab2021-05-10 13:04:001459Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD125U/mlCalibrationEvaluatedCrossreactivityEvaluatedFp0AUFn1AUPrecisionEvaluatedAccuracy99.55%RobustnessEvaluatedClinical Sensitivity97.82%1901SARS-Cov-2 Antigen Rapid Test Cassette (Saliva)381Spring Healthcare Services AGSwitzerlandwww.springhealthcare.org/YesCommercialisedNoNoCassetteLateral flowManualNear POC / POCAntigenSalivaSARS-Cov-2 Antigen Rapid Test Cassette (Saliva) is a rapid chromatographic immunoassay for the qualitative detection of specific antigens from SARS-CoV-2 present in human saliva within the first 7 days of symptom onset. This test is for profes- sional used only, as an aid to early diagnosis of SARS-CoV-2 infection in patient.2021-05-10 13:18:201577Immuno-AntigenNoImmunoassayQualitativeColorimetryOther10LOD125AUCalibrationEvaluatedCrossreactivityEvaluatedFp0%Fn3AUPrecisionEvaluatedAccuracy99.09%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.69%Clinical Specificity99.9%Type of antigenOther2030SARS-CoV-2 Antigen Rapid Test Cassette (saliva)933Merlin Biomedical (Xiamen) Co., Ltd.Chinahttp://www.merlinbio.com.cn/en/YesCommercialisedNoNoCassetteNear POC / POCAntigenSalivaBfArM-Vorgangsnummer: AT790/21 ISO 13485:2016 Certificate TÜV Süd No. Q5 106286 0001 Rev. 00 CE number: BE-CA01/1-16963-00006-IVD2021-05-10 13:04:001708Immuno-AntigenNoImmunochromatographyQualitative15LOD320AUCalibrationEvaluatedCrossreactivityEvaluatedFp6AUFn1AUPrecisionEvaluatedAccuracy98.4%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.5%Clinical Specificity99.7%Type of antigenNucleoprotein1952SARS-CoV-2 Antigen Rapid Test Cassette (nasal, nasopharyngeal, oropharyngeal, saliva)887Chinasejoy.com/YesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabSalivaWe have also evulated the interference substance.2021-05-10 13:04:001628Immuno-AntigenNoImmunochromatographyQualitativeSandwichOther20Peformance data provided by sample specimenLOD400AUCalibrationNot evaluatedCrossreactivityEvaluatedFp2(Nasal swab),3(Oropharyngeal swabs),2(Nasopharyngeal swabs),3(Saliva)Fn3(Nasal swab),5(Oropharyngeal swabs),3(Nasopharyngeal swabs),5(Saliva)PrecisionEvaluatedAccuracy98.48%(Nasal swab),98.67%(Oropharyngeal swabs),98.48%(Nasopharyngeal swabs),98.46%(Saliva)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.4%(Nasal swab),95.76%(Oropharyngeal swabs),97.4%(Nasopharyngeal swabs),95.65%(Saliva)Clinical Specificity99.1%(Nasal swab),99.38%(Oropharyngeal swabs),99.1%(Nasopharyngeal swabs),99.26%(Saliva)1945SARS-CoV-2 Antigen Rapid Test Cassette887Chinasejoy.com/YesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swabThe cross substances and interference substance are also evaluated.2021-05-10 13:04:001621Immuno-AntigenNoImmunochromatographyQualitativeSandwichOther20LOD400AUCalibrationEvaluatedCrossreactivityEvaluatedFp2AUFn3AUPrecisionEvaluatedAccuracy98.5%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.4%Clinical Specificity99.1%Type of antigenNucleoprotein2029SARS-CoV-2 Antigen Rapid Test Cassette933Merlin Biomedical (Xiamen) Co., Ltd.Chinahttp://www.merlinbio.com.cn/en/YesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swabNasopharyngeal swabBfArM Vorgangsnummer: AT214/20 Certificate TÜV Süd No. Q5 106286 0001 Rev. 00 CE number: BE-CA01/1-16963-00006-IVD2021-05-10 13:04:001707Immuno-AntigenNoImmunochromatographyQualitative15LOD160AUCalibrationEvaluatedCrossreactivityEvaluatedFp5AUFn1AUPrecisionEvaluatedAccuracy97%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.05%Clinical Specificity98.99%Type of antigenNucleoprotein1948SARS-CoV-2 Antigen Rapid Test (Swab)890Acro Biotech IncUnited Stateswww.acrobiotech.comYesCommercialisedNoNoCassetteLateral flowNear POC / POCAntigenNasal swabOropharyngeal swabThe ACROTM SARS-CoV-2 Antigen Rapid Test (Swab) is a lateral flow immunoassay for the qualitative detection of Nucleocapsid protein antigens of SARS-CoV-2 in swab specimens from individuals suspected of COVID-19 by their healthcare provider. The SARS-CoV-2 antigen is able to be detected in the upper respiratory tract during the acute phase of infection. The ACROTM SARS-CoV-2 Antigen Rapid Test (Swab) tests for the SARS-CoV-2 nucleocapsid protein antigen in upper respiratory specimens. While a positive result indicates the existence of the viral antigen, further evaluation of patient history and diagnostics are necessary to confirm these results. A patient may experience concurrent infection with other viruses or a bacterial infection which are not ruled out by a positive SARS-CoV-2 antigen result. Detection of the antigen does not surely certify it as the cause of the disease. Negative results should be treated as presumptive and confirmation with a molecular assay may be necessary for patient management. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.2021-05-10 13:04:001624Immuno-AntigenImmunoassayQualitative15LOD100AUCalibrationEvaluatedCrossreactivityEvaluatedFp0.006AUFn0.063AUPrecisionEvaluatedAccuracy96.7%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.7%Clinical Specificity99.4%Type of antigenNucleocapside1887SARS-CoV-2 Antigen Rapid Test (Sputum/Saliva/Stool)862Xiamen Wiz Biotech Co., LtdChinawww.wizbiotech.comYesCommercialisedNoNoCardManualAntigenSalivaSputumStoolNo2021-05-10 13:04:001566Immuno-AntigenImmunochromatographyQualitativeColorimetry15LOD170AUCalibrationEvaluatedCrossreactivityEvaluatedPrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluatedType of antigenOther1886SARS-CoV-2 Antigen Rapid Test (Saliva)862Xiamen Wiz Biotech Co., LtdChinawww.wizbiotech.comYesCommercialisedNoNoCardManualAntigenSalivaNO.2021-05-10 13:04:001565Immuno-AntigenImmunochromatographyQualitativeColorimetry20LOD170AUCalibrationEvaluatedCrossreactivityEvaluatedFp0%No false positives were found in 899 samples tested.Fn1.78%16 false negatives were found in 899 samples tested.PrecisionEvaluatedAccuracy98.22%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.35%Clinical Specificity100%1895SARS-CoV-2 Antigen Rapid Test (Nasal/Saliva)230Selfdiagnostics Deutschland GmbHGermanyselfdiagnostics.comYesCommercialisedNoNoCassetteLateral flowStripNear POC / POCAntigenNasal swabSalivaINTENDED USE The SARS-CoV-2 Antigen Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection the nucleocapsid protein antigen from SARS-CoV-2 in nasal and nasopharyngeal swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first seven days of the onset of symptoms. The SARSCoV- 2 Antigen Rapid Test can also be used for testing specimens from asymptomatic individuals. The SARS-CoV-2 Antigen Rapid Test does not differentiate between SARS-CoV and SARS-CoV-2. Results are for the identification of SARS-CoV-2 nucleocapsid antigen. This antigen is generally detectable in upper respiratory samples during the acute phase of infec-tion. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or coinfection with other viruses. The agent detected may not be the definite cause of disease. Negative results, from patients with symptom beyond seven days, should be treated as presumptive and confirmed with a molecular assay, if necessary, for patient management. Negative results do not rule out SARSCoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19. The SARS-CoV-2 Antigen Rapid Test is intended for use by trained clinical laboratory personnel and individuals trained in point of care settings. SARS-CoV-2 Antigen Rapid Test is intended to be used as an aid in the diagnosis of SARS-CoV-2 infection.2021-05-17 09:46:141572Immuno-AntigenYesImmunochromatographyQualitative15 SARS-CoV-2 antigen rapid test kit is a lateral flow chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigens in nasal swab or saliva specimens. LOD160AUCalibrationEvaluatedCrossreactivityEvaluatedPrecisionEvaluatedAccuracy98%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.1%(95% CI: 93.1%-98.9%)Clinical Specificity99.5%(95% CI: 98.2%-99.9%)Type of antigennucleocapsid1865SARS-CoV-2 Antigen Rapid Test (Nasal/Saliva)565Acon Biotech (Hangzhou) Co., LtdChinawww.aconbio.com/YesCommercialisedNoNoCassetteLateral flowNear POC / POCAntigenNasal swabSalivaN/A2021-05-10 13:18:201908SARS-CoV-2 Antigen Rapid Test (Nasal/Saliva)683ACON Laboratories, IncUnited Stateswww.aconlabs.comYesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swabSalivaN.A.2021-05-10 13:18:201583Immuno-AntigenYesImmunoassayMembrane-based15LOD160AUFp0.462 out of 435(Nasal Swab); 1 out of 236(Saliva)Fn2.945 out of 170(Nasal Swab); 9 out of 105(Saliva)PrecisionEvaluatedAccuracy98.8%98.8%(Nasal Swab); 97.1%(Saliva)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.1%97.1%(Nasal Swab); 91.4%(Saliva); Clinical Specificity99.5%99.5%(Nasal Swab); 99.6%(Saliva); Type of antigenNucleoprotein1341SARS-CoV-2 Antigen Rapid Test (Immunochromatography)286Qingdao Hightop Biotech Co., LtdChinawww.hightopbio.com/YesCommercialisedYesNoCassetteNear POC / POCAntigenNasal swab2021-05-10 13:04:001119Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD2000U/mlClinical Sensitivity95%Type of antigennucleoprotein1366SARS-CoV-2 Antigen Rapid Test (Immunochromatography)654SHANDONG KANGHUA BIOTECHNOLOGY CO., LTDChinaWWW.KHBIO.COMYesCommercialisedNoNoCassetteNear POC / POCAntigenNasopharyngeal swabOropharyngeal swab2021-05-10 13:04:001129Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD1400AUFp0.25%1 false positive to 400 negative samplesFn5%5 false negatives to 100 positive samplesAccuracy98.8%(Antigen)Clinical Sensitivity95%(Antigen)Clinical Specificity99.75%Type of antigennucleoprotein1884SARS-CoV-2 Antigen Rapid Test (Colloidal Gold)862Xiamen Wiz Biotech Co., LtdChinawww.wizbiotech.comYesCommercialisedNoNoCardManualAntigenAnterior nasal swabNO.2021-05-10 13:04:001563Immuno-AntigenImmunochromatographyQualitativeColorimetry15LOD170AUCalibrationEvaluatedCrossreactivityEvaluatedFp0%No false positives were found in 899 samples tested.Fn1.56%14 false negatives were found in 899 samples tested.PrecisionEvaluatedAccuracy98.37%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.91%Clinical Specificity100%Type of antigenOther1457SARS-CoV-2 Antigen Rapid Test565Acon Biotech (Hangzhou) Co., LtdChinawww.aconbio.com/YesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swab2021-05-10 13:04:001209Immuno-AntigenNoNoChromatographyQualitative45LOD1.61025AUCalibrationEvaluatedCrossreactivityEvaluatedFp99.5%CI (98.1%-99.9%)Fn96.9%CI (92.8%-98.9%)PrecisionEvaluatedAccuracy98.8%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.9%Type of antigennucleoprotein1338SARS-CoV-2 Antigen Rapid Test649TBG BIOTECHNOLOGY XIAMEN IncChinawww.tbgxm.comYesCommercialisedNoNoNear POC / POCAntigenNasal swab2021-05-10 13:04:001107Immuno-AntigenYesNoImmunoassayQualitative20Type of antigennucleoprotein1616SARS-COV-2 Antigen Rapid Test719Zhuhai Encode Medical Engineering Co., LtdChinawww.encode.com.cn/YesCommercialisedNoNoCassetteNear POC / POCAntigenNasopharyngeal swab http://www.encode.com.cn/en/about.asp2021-05-10 13:04:001296Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15Clinical Sensitivity95%Clinical Specificity100%1964SARS-CoV-2 Antigen Rapid test834BN SantéFrancewww.callmedicall.com/YesCommercialisedNoNoAntigenNasal swabNo additional information2021-05-10 13:04:001640Immuno-AntigenNoImmunochromatographyQualitative15LOD160AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0.5%Fn2.9%PrecisionEvaluatedAccuracy98.8%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.1%Clinical Specificity99.5%Type of antigenNucleoprotein1604SARS-CoV-2 Antigen Rapid Test854Roche (SD BIOSENSOR)Switzerlanddiagnostics.roche.comYesCommercialisedYesYesLateral flowNear POC / POCAntigenNasopharyngeal swab2021-05-10 20:07:301285Immuno-AntigenYesNoImmunoassayQualitative15Clinical Sensitivity96.52%Clinical Specificity99.2%Type of antigennucleocapside protein1685SARS-CoV-2 Antigen Rapid Qualitative Test756Xiamen Biotime Biotechnology Co., Ltd.Chinawww.biotime.cn/En_YesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swabOther2021-05-10 13:04:001364Immuno-AntigenYesNoImmunoassayQualitativeColorimetry20LOD0AUCalibrationevaluatedCrossreactivityevaluatedFp0Fn4%PrecisionevaluatedAccuracy98.98%(95%CI: 97.06%-99.79%)ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity96%(95%CI: 88.75%-99.17%)Type of antigennucleoprotein1801SARS-CoV-2 Antigen Rapid Qualitative Test821Innova Medical Group, Inc.United Stateswww.innovamedgroup.comYesCommercialisedNoNoLab-basedAntigenNasal swabSputumThroat swab2021-05-10 13:04:001480Immuno-AntigenYesImmunochromatographyQualitativeColorimetryCrossreactivityEvaluatedClinical Sensitivity96%CI95%:8 8.75%-99.17%Clinical Specificity100%CI95%: 98.34%-100.00%Type of antigennucleocapsid1293SARS-CoV-2 Antigen quantitative assay kit (Enzyme-linked immunoassay)53BIOHIT HealthCare (Hefei) Co., LtdChinawww.biohit.cnYesCommercialisedNoNoAutomatedManualAntigenPlasmaSerum2021-05-10 13:04:001066Immuno-AntigenImmunoassayQuantitativeLOD20TCID50/mlLOD1.66pgper mlClinical Sensitivity95%Clinical Specificity100%1197SARS-CoV-2 Antigen Kit (Colloidal Gold)117Goldsite Diagnostics IncChinaen.goldsite.com.cn/YesCommercialisedNoNoNear POC / POCAntigenNasal swabOther2021-05-10 13:04:00983Immuno-AntigenYesNoImmunoassayQualitativeColloidal gold122026SARS-CoV-2 antigen IVD kit SWAB930Shenzhen Reagent Technology Co.,Ltd.Chinawww.reagen.usYesCommercialisedNoNoCardLateral flowStripManualAntigenAnterior nasal swabNasal swabNasopharyngeal swabOropharyngeal swabThroat swab2021-05-10 13:04:001704Immuno-AntigenYesImmunochromatographyQualitativeSandwich, DoubleOther15LOD312.5AUCalibrationEvaluatedCrossreactivityEvaluatedFp4.76%105 positive samples detected 5 false positivesFn3.22%155 negative samples detected 5 false negativesPrecisionEvaluatedAccuracy96.9%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.2%Clinical Specificity98.1%Type of antigenNucleoprotein1235SARS-Cov-2 Antigen Fluorescence Rapid Detection Kit414Beijing Savant Biotechnology Co., LtdChinawww.huaketai.com/YesCommercialisedNoNoCassetteNear POC / POCAntigenOropharyngeal swab2021-05-10 13:04:001017Immuno-AntigenYesNoImmunoassayQualitativeFluorescence15LOD50ng/mL140SARS-CoV-2 Antigen ELISA Kit82Creative DiagnosticsUnited Stateswww.creative-diagnostics.com/NoCommercialisedNoNoAutomatedManualAntigenPlasmaSerum2021-05-10 13:04:00105Immuno-AntigenYesELISAQuantitativeFluorescenceClinical Sensitivity98%Clinical Specificity98%1950SARS-CoV-2 Antigen Detection Kit (Latex Lateral Flow Assay)891Shenzhen Biocup Biotech Co., Ltd.,Chinawww.bio-cup.comYesCommercialisedNoNoLateral flowLatexManualAntigenNasopharyngeal swabShenzhen Biocup Biotech Co., Ltd., established in 2000, is a biomedical high-tech enterprise dedicated to the research, development, production and sales of in vitro diagnostic reagents and medical laboratory instruments. Our company has successively won the honorary titles of "Shenzhen high tech enterprise" and "national high tech enterprise", ISO9000, ISO13485 quality management system certification and CE certification.2021-05-10 13:04:001626Immuno-AntigenNoImmunochromatographyQualitativeSandwich, DoubleSample collection device15LOD45AUCalibrationEvaluatedCrossreactivityEvaluatedFp7%The probability of false positive is 7%.Fn1.18%The probability of false negative is 1.18%.PrecisionEvaluatedAccuracy95.5%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93%Clinical Specificity98.82%Type of antigenNucleoprotein1575SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Method)693Wenzhou OJA Biotechnology Co., LTD.Chinawww.ojabio.netYesCommercialisedNoNoCardNear POC / POCAntigenNasal swabOther2021-05-10 13:04:001254Immuno-AntigenYesNoImmunoassayQualitativeColorimetrySample preparation15LOD1AUCalibrationevaluatedCrossreactivityevaluatedFp1.712 of 117Fn0.451 of 220PrecisionevaluatedAccuracy99.1%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity98.29%Clinical Specificity99.55%Type of antigennucleoprotein1588SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Method)699Xiamen Jiqing Biomedical Technology Co., Ltd.Chinawww.wikang.com.cnYesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swabSalivaThroat swab2021-05-10 13:04:001268Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD10AUCalibrationevaluatedCrossreactivityevaluatedFp5.75AUFn0AUPrecisionevaluatedAccuracy97.58%(Antigen)ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity94.25%(Antigen)Type of antigennucleoprotein1660SARS-Cov-2 Antigen Assay kit by Latex Immunochromatography method743Sichuan Xincheng Biological Co., LTDChinawww.xinchengbio.com/en/YesCommercialisedNoNoLatexNear POC / POCAntigenNasal swab2021-05-10 13:04:001339Immuno-AntigenYesNoImmunoassayQualitative15LOD500AUCalibrationevaluatedCrossreactivityevaluatedFp0.95%Fn5.7%PrecisionevaluatedAccuracy96.9%(Antigen)ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity94.2%(Antigen)Type of antigennucleoprotein1659SARS-Cov-2 Antigen Assay kit by Immunofluorescence Chromatography method743Sichuan Xincheng Biological Co., LTDChinawww.xinchengbio.com/en/YesCommercialisedNoNoCardNear POC / POCAntigenNasal swab2021-05-10 13:04:001338Immuno-AntigenYesImmunoassayQualitativeFluorescence15LOD500AU500CalibrationevaluatedCrossreactivityevaluatedFp0.47%Fn3.8%PrecisionevaluatedAccuracy98%(Antigen)ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity96.2%(Antigen)Type of antigennucleoprotein1711SARS-CoV-2 Antigen (GICA)761MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.Chinawww.medcaptain.comYesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swab2021-05-10 13:04:001391Immuno-AntigenNoImmunoassayQualitativeColorimetry15LOD1250AUCalibrationnot evaluatedCrossreactivityevaluatedFp4.9%Fn6.2%PrecisionevaluatedAccuracy94.7%(Antigen)ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity93.8%(Antigen)Type of antigennucleoprotein1820SARS-CoV-2 Antigen (Colloidal Gold)112Getein Biotech, IncChinaen.bio-gp.com.cn/YesCommercialisedNoNoLateral flowManualAntigenNasal swabSalivaOne Step Test for SARS-CoV-2 Antigen (Colloidal Gold) is intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in human nasal swab samples or saliva samples from patients suspected of COVID-19 infection by a healthcare provider.2021-05-10 13:18:201498Immuno-AntigenNoImmunoassayQualitativeSandwichColloidal goldVisualisation system10The antigen test has been validated by Germany for the use. PEI report is availableLOD200AUCalibrationEvaluatedCrossreactivityEvaluatedFp2.9%5 of 170Fn2.9%5 of 170PrecisionEvaluatedAccuracy98.13%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.06%Clinical Specificity98.71%Type of antigennucleoprotein2061SARS-CoV-2 Antigen 951VIDIA spol. s r.o.Czechiawww.vidia.czYesCommercialisedNoNoCassetteManualNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabLOD = 100pg/ml or 1,16 x 10^2 TCID 50/ml2021-05-17 10:24:301741Immuno-AntigenNoImmunochromatographyQualitativeCapture15LOD100AUCalibrationNot evaluatedCrossreactivityEvaluatedFp2.42%Fn1%PrecisionEvaluatedAccuracy98%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96%Clinical Specificity99%Type of antigenNucleoprotein2035SARS-CoV-2 Ag Rapid Test937BioMaxima SAPolandwww.biomaxima.comYesCommercialisedNoNoCassetteManualNear POC / POCAntigenNasopharyngeal swabCat. No. 1-367-K020, the SARS-CoV-2 Ag Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in nasopharyngeal swab specimens from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests.2021-05-10 13:04:001713Immuno-AntigenNoImmunochromatographyQualitativeCapture10LOD160AUCalibrationNot evaluatedCrossreactivityEvaluatedFp2AUFn5AUPrecisionEvaluatedAccuracy97%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95%Clinical Specificity99%Type of antigenNucleoprotein1768SARS-CoV-2 Ag Diagnostic Test Kit (Immuno-fluorescence)793Shenzhen Watmind Medical Co., LtdChinawww.watmind.comYesCommercialisedNoNoCardLateral flowAutomatedNear POC / POCAntigenNasal swab2021-05-10 13:04:001447Immuno-AntigenYesImmunochromatographyQualitativeFluorescence10LOD80U/mlCalibrationEvaluatedCrossreactivityEvaluatedFp1AUFn9AUPrecisionEvaluatedAccuracy96.3%ReproducibilityEvaluatedClinical Sensitivity97.83%CT value ≤33Clinical Sensitivity90.08%CT value ≤36Type of antigenNucleoprotein1769SARS-CoV-2 Ag Diagnostic Test Kit (Colloidal Gold)793Shenzhen Watmind Medical Co., LtdChinawww.watmind.comYesCommercialisedYesYesCassetteNear POC / POCAntigenNasal swabSaliva2021-05-10 20:07:301448Immuno-AntigenYesNoImmunochromatographyQualitativeColorimetry10LOD150U/mlCalibrationEvaluatedCrossreactivityEvaluatedFp1AUFn5AUPrecisionEvaluatedAccuracy93.7%Clinical Sensitivity95.15%for onset of symptoms within 7 daysType of antigenNucleoprotein1839624Zhejiang Anji Saianfu Biotech Co., LtdChinawww.seinofy.comYesCommercialisedNoNoCassetteManualAntigenNasal swabOropharyngeal swabSputumThroat swab2021-05-10 13:18:201526Immuno-AntigenImmunoassay1774SARS-CoV-2 / Influenza Virus A/ Influenza Virus B Antigen Assay Kit (Immunochromatography)792Wuhan Life Origin Biotech Joint Stock Co., Ltd.Chinawww.szybio.comYesCommercialisedNoNoCardLateral flowNear POC / POCAntigenNasal swab2021-05-10 13:04:001453Immuno-AntigenYesYesImmunochromatographyQualitative15LOD0U/mlCalibrationEvaluatedCrossreactivityEvaluatedFp1.7%PrecisionEvaluatedAccuracy96.6%(483/500), 95%CI(94.61%-98.01%).ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.67%(139/150), 95%CI(87.26%-96.28%).561SARS-CoV-2 (COVID-19) nucleocapsid protein (GTX135357-pro)353GeneTex International CorporationUnited Stateswww.genetex.com/NoCommercialisedNoNoAutomatedManualAntigen2021-05-10 13:04:00476Immuno-AntigenImmunoassay907SARS-CoV-2 (2019-nCoV) Spike RBD ELISA Kit502Sino BiologicalChinawww.sinobiological.comNoCommercialisedNoNoAutomatedManualAntigen2021-05-10 13:04:00719Immuno-AntigenELISA906SARS-CoV-2 (2019-nCoV) Spike Detection ELISA Kit502Sino BiologicalChinawww.sinobiological.comNoCommercialisedNoNoAutomatedManualAntigen2021-05-10 13:04:00715Immuno-AntigenELISA905SARS-CoV-2 (2019-nCoV) Nucleocapsid Detection ELISA Kit502Sino BiologicalChinawww.sinobiological.comNoCommercialisedNoNoAutomatedManualAntigen2021-05-10 13:04:00714Immuno-AntigenELISA2063952Chinahttp://www.sejoy.com.cn/YesCommercialisedNoNoCassetteNear POC / POCAntigenNasopharyngeal swabOropharyngeal swabWe have also evaluated the interference substances.2021-05-17 10:38:231743Immuno-AntigenNoImmunoassayQualitativeSandwichOther20LOD40050AUCalibrationNot evaluatedCrossreactivityEvaluatedFp2AUFn3AUPrecisionEvaluatedAccuracy98.5%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.4%Clinical Specificity99.1%Type of antigenNucleoprotein1762SARS CoV-2 Antigen Rapid Test661NovatechTurkeywww.novadiag.comYesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swabOtherSaliva2021-05-10 13:18:201441Immuno-AntigenYesNoImmunochromatographyQualitative15LOD1.7U/mlAnalytical Sensitivity97.54%Crossreactivity0AUFp4AUFn0AUPrecisionEvaluatedAccuracy99.11%RobustnessEvaluatedType of antigenNucleoprotein1986SARA-CoV-2 Antigen Rapid Test Kit906Diasia Biomedical Technology Co., Ltd.Chinawww.diasia.com.cnYesCommercialisedNoNoAntigenNasal swabLOD (U/ml) ：9.975 x 102 TCID50/mL The BFARM list is 573/21 2021-05-10 13:04:001662Immuno-AntigenImmunoassay15LOD9.9751025AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0.71%(140 specimens were negative by both test reagent and control reagent, and there is 1 specimen of falFn3.12%(128 specimens were positive by both test reagent and control reagent, and there are 4 specimens of fPrecisionNot evaluatedAccuracy98.17%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.97%Clinical Specificity99.29%Type of antigenNucleoprotein1782Saligen – Rapid Antigen Saliva Test798Bakter Medical s.r.o.Czechiawww.saligen.comYesCommercialisedNoNoCardNear POC / POCAntigenSaliva2021-05-10 13:04:001461Immuno-AntigenNoImmunochromatographyQualitativeColorimetry10LOD0.1AUCalibration0Crossreactivity0Fp0%Fn1AUPrecision0Accuracy98.55%Robustness0Clinical Sensitivity97.1%Type of antigen02039S2 Covid-19 Rapid Antigen Test Kit940Sensing Self Pte. Ltd.Singaporewww.sensingself.meYesCommercialisedNoNoCardManualNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabThe S2 Covid-19 Rapid Antigen Test Kit LOD value is 1.25 X 103 TCID50/mL.2021-05-10 13:04:001717Immuno-AntigenNoImmunochromatographyQualitativeSandwich, Double15LOD1250TCID50/mlCalibrationEvaluatedCrossreactivityEvaluatedFp0%(450 samples are proven negative of 450 negative specimens)Fn2.87%(6 samples are proven negative of 209 positive specimens)PrecisionEvaluatedAccuracy99.09%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.13%Clinical Specificity99.99%Type of antigenNucleoprotein1493S1 Covid-19 Rapid Antigen Test Kit687Sensing Self Pte., LtdSingaporewww.sensingself.meYesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swabOtherSaliva2021-05-10 13:04:001243Immuno-AntigenYesNoImmunoassayQualitative15LOD0.005AUCalibrationevaluatedCrossreactivityevaluatedFp1%Fn5%PrecisionevaluatedAccuracy96.9%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity94%Type of antigennucleoprotein1846RIDA®@QUICK SARS-CoV-2 Antigen217R-Biopharm AGGermanyr-biopharm.com/YesCommercialisedNoNoDipstickLateral flowManualNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabThroat swabN/A2021-05-10 13:04:001522Immuno-AntigenNoImmunochromatographyQualitativeColorimetryN.A.20LOD237AUCalibrationEvaluatedCrossreactivityEvaluatedFpN/AFnN/APrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.7%Clinical Specificity97.4%Type of antigenNucleoprotein446ReSARS Pan-Corona Antigen ELISA Kit281Zalgen Labs, LLCUnited Stateswww.zalgen.com/NoIn developmentNoNoAutomatedManualAntigen2021-05-10 13:04:00358Immuno-AntigenELISA448ReSARS CoV-2 Antigen Rapid Test281Zalgen Labs, LLCUnited Stateswww.zalgen.com/NoIn developmentNoNoNear POC / POCAntigen2021-05-10 13:04:00362Immuno-AntigenYesImmunoassay449ReSARS CoV-2 Antigen ELISA Kit281Zalgen Labs, LLCUnited Stateswww.zalgen.com/NoIn developmentNoNoAutomatedManualAntigen2021-05-10 13:04:00363Immuno-AntigenELISA1295reOpenTest COVID-19 Antigen Rapid Test624Zhejiang Anji Saianfu Biotech Co., LtdChinawww.seinofy.comYesCommercialisedYesNoCassetteNear POC / POCAntigenNasal swabPlasmaSaliva2021-05-10 19:40:141094Immuno-AntigenYesImmunoassayQualitativeColorimetry15Fp95.8%Fn99%Accuracy97.9%Clinical Sensitivity95.8%Type of antigennucleoprotein1832RapiGEN Inc.220RapiGEN IncSouth Korearapigen-inc.comYesCommercialisedNoNoLateral flowManualAntigenNasopharyngeal swabhttp://rapigen-inc.com/wp/portfolio-items/covid-19ag/?lang=en2021-05-10 13:18:201511Immuno-AntigenImmunoassay1453RAPIDTECH Test Rapide Antigène SARS-CoV-2675Weifang Kanghua BiotechChinawww.khbio.com/EN/yxwl.aspxYesCommercialisedNoNoCardNear POC / POCAntigenNasal swabOther2021-05-10 13:04:001202Immuno-AntigenYesNoImmunoassayQualitative15LOD2000IU/mlCalibrationevaluatedCrossreactivityevaluatedFp9.1%3/33Fn0.1%1/1002PrecisionevaluatedAccuracy97%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity91%Type of antigennucleoprotein1823RAPIDIGEN COVID19 AG IMMUNOASSAY830Pharmaline ASTurkeypharmaline.com.tr/enYesCommercialisedNoNoCassetteLateral flowAutomatedAntigenNasal swabNasopharyngeal swabOropharyngeal swabThroat swab2021-05-10 13:04:001501Immuno-AntigenYesNoImmunochromatographyQualitativeMagnetic ElectrochemicalVisualisation system15LOD30AUCalibrationEvaluatedCrossreactivityEvaluatedFpSample contamination or not following the IFU protocolFnSample contamination or not following the IFU protocolPrecisionEvaluatedAccuracy98%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93%Clinical Specificity99%1443RapidFor SARS-CoV-2 Rapid Ag Test678Vitrosens Biotechnology Co., LtdTurkeywww.vitrosens.comYesCommercialisedYesNoCassetteNear POC / POCAntigenNasal swabSaliva2021-05-10 19:40:141194Immuno-AntigenYesNoImmunoassayQualitativeColorimetry10LOD100IU/mlCalibrationevaluatedCrossreactivityevaluatedFp1AUFn1AUPrecisionevaluatedAccuracy98.3%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity97.3%Type of antigennucleoprotein1458RapidFor SARS-CoV-2 Antigen Test Kit678Vitrosens Biotechnology Co., LtdTurkeywww.vitrosens.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabSaliva2021-05-10 13:04:001210Immuno-AntigenYesNoImmunoassayQualitativeColorimetry10LOD100IU/mlCalibrationevaluatedCrossreactivityevaluatedFp1%Fn1%PrecisionevaluatedAccuracy98%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity97.3%Type of antigennucleoprotein1751RAPIDAN TESTER Covid-19 Ag Test758TurklabTurkeywww.turklab.com.tr/YesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swabNasopharyngeal swabThroat swab2021-05-10 13:18:201429Immuno-AntigenYesNoImmunochromatographyQualitative20LOD30U/mlCalibrationNot evaluatedCrossreactivityEvaluatedFp12AUFn3AUPrecisionEvaluatedAccuracy97.57%RobustnessEvaluatedClinical Sensitivity93.18%Type of antigenNucleoprotein1602Rapid Test SARS-CoV-2 Ag531AMEDA Labordiagnostik GmbHAustriawww.amp-med.com/YesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swab2021-05-10 13:18:201283Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15Rapid diagnostic test cassette colloidal gold LOD115TCID50/mlCrossreactivityno cross reaction with RSV type A, RSV type B, novel influenza A H1N1,, Influenza A H3N2, Influenza A H5N1, Influenza B yamagata, Influenza B Victoria, Rhinovirus, Adenovirus 3, Adenovirus 7, EV-A71, Mycobacterium tuberculosis, Micoplasma pneumoniae, MumFp2.7%3 of 111Fn0%0 of 139Accuracy98.8%Clinical Sensitivity97.3%Clinical Specificity100%Type of antigennucleocapside protein1240RAPID TEST AntigenE GCCOV-502a760Zhezhiang Orient Gene Biotech Co., LtdChinawww.orientgene.com/YesCommercialisedNoNoCassetteNear POC / POCAntigenNasopharyngeal swabhttps://www.innoliving.it/nuovo-test-rapido-Antigene-naso-faringeo-presentato-da-innoliving/2021-05-10 13:18:201022Immuno-AntigenYesNoImmunoassayQualitative15Clinical Sensitivity86.7%Clinical Specificity100%Type of antigenspike proteins1824Rapid Test Antigen SARS- CoV-2160Liming Bio-Products Co., LtdChinawww.limingbio.com/YesCommercialisedNoNoMicroplateStripManualAntigenNasopharyngeal swabOropharyngeal swab20 Test per confezione - Due filale di diluizione - 20 tubi di estrazione - 20 confezioni tamponi - 1 postazione lavoro2021-05-10 13:18:201508Immuno-AntigenImmunoassay1495Rapid Test Ag 2019-nCov688Prognosis BiotechGreecewww.prognosis-biotech.com/YesCommercialisedNoNoStripNear POC / POCAntigenNasal swab2021-05-10 13:04:001245Immuno-AntigenYesNoImmunoassayQualitative15LOD2870AUCalibrationevaluatedCrossreactivityevaluatedFp6%Fn2%PrecisionevaluatedAccuracy98.69%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity95.56%Type of antigennucleoprotein1791Rapid SARS-Cov2 Antigen Test806Immunospark s.r.l.Italywww.immunospark.comYesCommercialisedNoNoCardNear POC / POCAntigenNasal swabSaliva2021-05-10 13:04:001470Immuno-AntigenYesNoImmunochromatographyQualitativeChemiluminescence10LOD3.22IU/mlFp0AUFn0AUAccuracy98.5%Clinical Sensitivity94.12%1278Rapid SARS-CoV-2 Antigen Test Card277Xiamen Boson Biotech Co. LtdChinabosonbio.com/YesCommercialisedYesYesCassetteNear POC / POCAntigenNasopharyngeal swab2021-05-10 13:04:001053Immuno-AntigenYesImmunochromatographyQualitative15LOD1300TCID50/ml1481Rapid SARS-CoV-2 Antigen Test Card367MP BiomedicalsUnited Stateswww.mpbio.com/YesCommercialisedYesYesLateral flowNear POC / POCAntigenNasal swab2021-05-10 20:07:301232Immuno-AntigenYesNoImmunoassayQualitative15LOD1AUCalibrationEvaluatedCrossreactivityEvaluatedFpClinical study result: 4 false positives out of 414 PCR negative samplesFnClinical study result: 3 false negatives out of 83 PCR positive samplesPrecisionEvaluatedAccuracy98.59%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.39%Clinical Specificity99.03%Type of antigennucleoprotein1783Rapid SARS-CoV-2 Antigen Test147InTec Products, IncChinawww.intecasi.com/YesCommercialisedNoNoCardNear POC / POCAntigenNasal swab2021-05-10 13:18:201462Immuno-AntigenNoImmunoassayQualitativeColorimetry15LOD0.13AU1684Rapid Response COVID-19 Antigen Rapid Test Cassette (Oral Fluid)62BTNX IncCanadawww.btnx.com/YesCommercialisedNoNoCassetteNear POC / POCAntigenSaliva2021-05-10 13:18:201363Immuno-AntigenYesNoImmunoassayQualitative10LOD1000AUCalibrationevaluatedCrossreactivityevaluatedFp0%Fn5%PrecisionevaluatedAccuracy99.5%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity95%Type of antigennucleoprotein1236Rapid Response COVID-19 Antigen Rapid Test62BTNX IncCanadawww.btnx.com/YesCommercialisedYesNoCassetteLateral flowNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swab https://www.btnx.com/files/1110032811V5_COVID-19_Antigen_Rapid_Test_Device.pdf2021-05-10 19:40:131018Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich15LOD502.38TCID50/mlCrossreactivityEvaluatedFp0AUFn5AUPrecisionEvaluatedAccuracy97.2%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90.2%Clinical Specificity100%Type of antigenNucleoprotein1822Rapid COVID-19 Antigen Test(Colloidal Gold)307Anbio (Xiamen) Biotechnology Co., LtdChinawww.anbio.com/YesCommercialisedYesNoCassetteLateral flowNear POC / POCAntigenNasal swabThroat swab1.This product was evaluated and approved by Paul-Ehrlich-Institute in Germany in Feb 2021. 2.This product was evaluated and approved by National Institutes for Food and Drug Control China in Dec 2020. 3.The LOD for this product was 425 TCID50/mL.2021-05-10 19:40:141732Immuno-AntigenYesImmunoassay1735Rapid COVID-19 Antigen Test554Healgen ScientificUnited Stateswww.healgen.comYesCommercialisedNoNoCardCassetteNear POC / POCAntigenNasal swabOther2021-05-10 13:18:201414Immuno-AntigenYesNoImmunoassayQualitativeColloidal gold15LOD115U/mlCalibrationNot EvaluatedCrossreactivityEvaluatedFp0.35%3 of 865Fn0.23%2 of 865PrecisionNot EvaluatedAccuracy99.42%ReproducibilityNot evaluatedRobustnessNot EvaluatedClinical Sensitivity98.32%Type of antigenNucleoprotein1182Rapid COVID-19 Antigen Qualitative Test Kit77Megna Health IncUnited Stateswww.megnahealth.comYesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swabOtherSalivaMegna Health requests the addition of this IVD Test Kit to the CE approved listing. The device is manufactured by Megna Health - and the EU Authorized Representative is MDSS (Germany). Notification of this COVID IVD has been made to the Competent Authority in Germany2021-05-10 13:04:00964Immuno-AntigenYesNoImmunoassayQualitative2010RabWiz Ultra Sensitive COIV-19 Viral Antigen Test Kit (ELISA)8Abwiz BioUnited Stateswww.abwizbio.com/NoIn developmentNoNoN.A.AutomatedManualAntigen2021-05-10 13:04:0010Immuno-AntigenELISAManual or automated 1267QuickProfile COVID-19 Antigen Test167LumiQuick Diagnostics IncUnited Stateslumiquick.co/YesCommercialisedYesYesStripNear POC / POCAntigen2021-05-10 20:07:301042Immuno-AntigenYesImmunoassayQualitative15LOD380TCID50/ml1264PerfectPOC Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit145Jiangsu Bioperfectus Technologies Co. LtdChinawww.bioperfectus.comYesCommercialisedNoNoNear POC / POCAntigen2021-05-10 13:04:001039Immuno-AntigenYesImmunoassay308PCL COVID19 Ag Rapid FIA202PCL IncSouth Koreawww.pclchip.com/YesCommercialisedYesYesNear POC / POCAntigen2021-05-10 20:07:30260Immuno-AntigenYesImmunoassay1758PCL COVID19 Ag Gold202PCL IncSouth Koreawww.pclchip.com/YesCommercialisedNoNoCardNear POC / POCAntigenNasal swabSaliva2021-05-10 13:04:001270Pantest Coronavirus Ag599Pantest SAPolandwww.pantest.pt/YesCommercialisedNoNoCassetteNear POC / POCAntigenNasopharyngeal swabOropharyngeal swab2021-05-10 13:04:001045Immuno-AntigenYesImmunoassayQualitative20Clinical Sensitivity96%Clinical Specificity100%1232Panbio COVID-19 Ag Rapid Test628Abbott Rapid DiagnosticsUnited Stateswww.globalpointofcare.abbott/YesCommercialisedYesYesCassetteLateral flowManualNear POC / POCAntigenNasal swabNasopharyngeal swabPanbio™ COVID-19 Ag Rapid Test clinical studies support: - the use for asymptomatic screening (93.8% sensitivity vs. nasal PCR reference, Ct values ≤ 30) - the self-administered sample collection with nasal swabs - the use on pediatric symptomatic and asymptomatic subjects Panbio™ COVID-19 Ag Rapid Test is WHO EUL qualified 2021-05-17 11:01:421015Immuno-AntigenYesNoImmunochromatographyQualitative15Accuracy97.8%Nasopharyngeal swabAccuracy99.4%Nasal swab (Ct values ≤ 33)Clinical Sensitivity91.4%Nasopharyngeal swab (Ct values ≤ 33)Clinical Sensitivity98.1%Nasal swab (Ct values ≤ 33)Clinical Specificity99.8%Nasopharyngeal swab (Ct values ≤ 33)Clinical Specificity99.8%Nasal swab (Ct values ≤ 33)Type of antigenNucleoprotein319P4DETECT COVID-19 SAg208PRIME4DIA Co., LtdSouth Koreawww.prime4dia.com/NoCommercialisedNoNoNear POC / POCAntigen2021-05-10 13:04:00267Immuno-AntigenYesImmunoassayType of antigenS1 domain of the spike protein321P4DETECT COVID-19 Ag208PRIME4DIA Co., LtdSouth Koreawww.prime4dia.com/NoCommercialisedNoNoNear POC / POCAntigen2021-05-10 13:04:00269Immuno-AntigenYesImmunoassayType of antigenrecombinant full length nucleocapsid protein1581OnSite COVID-19 Ag Rapid Test79CTK Biotech, IncUnited Stateswww.ctkbiotech.com/YesCommercialisedNoNoCassetteLateral flowNear POC / POCAntigenNasal swab2021-05-10 13:18:201260Immuno-AntigenYesNoImmunoassayQualitativeColorimetry20LOD280%CalibrationevaluatedCrossreactivityevaluatedFp0%Fn7.7%PrecisionevaluatedAccuracy100%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity92.3%Type of antigennucleoprotein1195OneStep COVID-19 Antigen RapiCard InstaTest582Diagnostic Automation/Cortez Diagnostics, IncUnited Stateswww.rapidtest.comYesCommercialisedNoNoNear POC / POCAntigenNasal swab2021-05-10 13:04:00980Immuno-AntigenYesYesImmunoassay15LOD38.55AUClinical Sensitivity95.52%1242NowCheck COVID-19 Ag Test633Bionote, IncSouth Koreabionote.co.kr/YesCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swab2021-05-10 19:37:301023Immuno-AntigenYesNoImmunoassayQualitative15LOD85TCID50/mlRange: 85-98.8Clinical Sensitivity89.2%Clinical Sensitivity90.8%Clinical Specificity97.6%1289Novel SARS-CoV-2 Coronavirus Spike Glycoprotein Detection Kit (S Protein-ACE2 receptor)642Apollo Biomedical LLCUnited Stateswww.apollobiomedical.comYesCommercialisedNoNoNear POC / POCAntigenSputumStoolThroat swab2021-05-10 13:04:001063Immuno-AntigenYesN.A.ImmunoassayQualitativeRapid diagnostic test Type of antigenACE2 receptor1259Novel Coronavirus S Glycoprotein Detection Kit634Hangzhou Deangel Biological Engineering Co., LtdChinadagbio.en.alibaba.com/company_profile.htmlYesCommercialisedNoNoNear POC / POCAntigen2021-05-10 13:04:001035Immuno-AntigenYesImmunoassay1798Novel Coronavirus 2019-nCoV Antigen Test (Colloidal Gold) - Saliva328Beijing Hotgen Biotech Co., LtdChinawww.hotgen.com.cn/YesCommercialisedNoNoNear POC / POCAntigenSalivaThis kit is used for in vitro qualitative determination of novel coronavirus antigen in human saliva samples from posterior oropharynx. It is used as rapid investigation for suspected cases of novel coronavirus, can also be used as a reconfirmation method for nucleic acid detection in discharged cases. A positive test result indicates that the samples contained novel coronavirus antigen. A negative test result does not rule out the possibility of infection. This product is only used for clinical and emergency reserve during the pneumonia outbreak of novel coronavirus infection, and can not be used as a routine in vitro diagnostic reagent for clinical application . The test results of this kit are for clinical reference only. It is recommended to conduct a comprehensive analysis of the condition based on the patient's clinical manifestations and other laboratory tests. For professional use only.2021-05-10 13:18:201477Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD250CalibrationNot evaluatedCrossreactivityEvaluatedFp0Fn0PrecisionEvaluatedAccuracy98.79ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96%Clinical Specificity99.78%1870Novel Coronavirus 2019-nCoV Antigen Test (Colloidal Gold)328Beijing Hotgen Biotech Co., LtdChinawww.hotgen.com.cn/YesCommercialisedYesYesLateral flowStripNear POC / POCAntigenSalivaThis kit is used for in vitro qualitative determination of novel coronavirus antigen in human nasal swabs or throat swabs. It is used as rapid investigation for suspected cases of novel coronavirus, can also be used as a reconfirmation method for nucleic acid detection in discharged cases. A positive test result indicates that the samples contained novel coronavirus antigen. A negative test result does not rule out the possibility of infection. This product is only used for clinical and emergency reserve during the pneumonia outbreak of novel coronavirus infection, and can not be used as a routine in vitro diagnostic reagent for clinical application . The test results of this kit are for clinical reference only. It is recommended to conduct a comprehensive analysis of the condition based on the patient's clinical manifestations and other laboratory tests. For professional use only.2021-05-10 20:07:301547Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich15LOD250AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0%Fn0%PrecisionEvaluatedAccuracy98.87%ReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity97.1%Clinical Specificity99.76%Type of antigenNucleoprotein1796Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (saliva)344Hangzhou Realy Tech Co., LtdChinawww.realytech.com/YesCommercialisedNoNoCassetteNear POC / POCAntigenSaliva2021-05-10 13:04:001475Immuno-AntigenYesNoImmunochromatographyQualitativeColorimetry20LOD125IU/mlFp0.42%Fn7.1%Accuracy96.79%Clinical Sensitivity92.9%2018Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (nasal swab)344Hangzhou Realy Tech Co., LtdChinawww.realytech.com/YesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swabThe Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (nasal swab)'s LOD value is 1.25 X 103 TCID50/mL.2021-05-10 13:04:001696Immuno-AntigenNoImmunochromatographyQualitativeMembrane-basedValidity test kit20LODAU1250CalibrationNot evaluatedCrossreactivityEvaluatedFp0%(430 samples are proven negative of 430 negative specimens)Fn4.61%(9 samples are proven negative of 195 positive specimens)PrecisionEvaluatedAccuracy98.56%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.38%Clinical Specificity99.9%(＞99.9%)Type of antigenNucleoprotein1220Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab)344Hangzhou Realy Tech Co., LtdChinawww.realytech.com/YesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swab2021-05-10 13:04:001005Immuno-AntigenYesNoImmunochromatographyQualitativeColorimetry15LOD1250TCID50/mlCalibrationNot evaluatedAnalytical Sensitivity96.17%CrossreactivityEvaluatedFp0%450 samples are proven negative of 450 negative specimensFn3.83%8 samples are proven negative of 209 positive specimensPrecisionEvaluatedAccuracy98.79%RobustnessEvaluatedType of antigenNucleorpotein1743Novel Coronavirus (SARS-Cov-2) Antigen rapid test344Hangzhou Realy Tech Co., LtdChinawww.realytech.com/YesCommercialisedNoNoCassetteLateral flowNear POC / POCAntigenNasal swabThis product is being used currently by Westland Health on the Irish market with its customers. All positive candidates who have tested positive with the Realy antigen test kit, have been subsequently confirmed positive by the Irish Health Service. 2021-05-10 13:04:001421Immuno-AntigenYesNoImmunoassayQualitative15LOD1250U/mlCalibrationEvaluatedCrossreactivityEvaluatedFpNot FoundFnNot FoundPrecisionEvaluatedAccuracy98.79%ReproducibilityNot EvaluatedRobustnessEvaluatedClinical Sensitivity97.14%1972Novel Coronavirus (SARS-CoV-2) Antigen Detection Kit(Colloidal Gold)30Avioq Bio-Tech Co., LtdChinawww.avioqbio.com/YesCommercialisedNoNoCassetteManualAntigenAnterior nasal swabNasopharyngeal swabNone2021-05-10 13:18:201648Immuno-AntigenNoImmunochromatographyQualitativeSandwichColloidal goldOther15LOD100AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0%Fn10.64%(5/47)PrecisionEvaluatedAccuracy96.84%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity89.36%Clinical Specificity100%Type of antigenNucleoprotein2041Novel Coronavirus (SARS-CoV-2) Antigen Detection Kit (Immunochromatography)941Vacure Prelab Medical Technology Co., Ltd.ChinaYesCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swab2021-05-10 13:04:001719Immuno-AntigenImmunochromatographySandwich15LOD1000AUCalibrationEvaluatedCrossreactivityEvaluatedFp0.53%Fn1.68%PrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.32%Clinical Specificity99.47%Type of antigenNucleoprotein1784Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold)801Medakit LtdHong Kong S.A.Rwww.medakit.comYesCommercialisedNoNoCardNear POC / POCAntigenNasal swabhttps://www.aphp.fr/contenu/evaluation-de-la-performance-diagnostique-de-neuf-tests-rapides-antigeniques-covid-192021-05-10 13:18:201463Immuno-AntigenNoImmunoassayQualitativeColorimetry15LOD0.5AUFp0AUFn1AUAccuracy98.12%Clinical Sensitivity95.07%1828Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold)834BN SantéFrancewww.callmedicall.com/YesIn developmentNoNoNear POC / POCAntigenNasal swabNo additional information2021-05-10 13:04:001505Immuno-AntigenImmunoassayColorimetry15LOD0.5AUCalibrationEvaluatedCrossreactivityEvaluatedFp8Fn1PrecisionEvaluatedAccuracy94.3%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity86.21%Clinical Specificity99%1795Novel Coronavirus (2019-nCOV) Antigen Rapid Test Cassette (Quantum Dot-based Fluorescence Immunochromatography)344Hangzhou Realy Tech Co., LtdChinawww.realytech.com/YesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swab2021-05-10 13:04:001474Immuno-AntigenYesNoImmunochromatographyFluorescence20LOD1250IU/mlFp0%Fn3.83%Accuracy98.79%Clinical Sensitivity96.17%1362Novel Coronavirus (2019-nCoV) Antigen Detection Kit (Quantum Dot-Based Fluorescence Immunochromatography)652Beijing WSWY Technology Co.,.LtdChinawww.wswygs.comYesCommercialisedNoNoCardNear POC / POCAntigenNasal swab2021-05-10 13:04:001121Immuno-AntigenYesNoImmunoassayQualitativeFluorescence15LOD60AUFp0%0Fn8.43%Accuracy98.21%(Antigen)Clinical Sensitivity91.57%(Antigen)Type of antigennucleoprotein1189Novegent COVID-19 Antigen Rapid Test Kit620Chongqing Novegent Biotech Company LimitedChinawww.novegent.cnYesCommercialisedNoNoNear POC / POCAntigenNasal swab http://www.novegent.eu/Antigen/2021-05-10 13:04:00970Immuno-AntigenYesNoImmunoassayQuantitativeColorimetry15Rapid diagnostic test colloidal gold LOD7AUAccuracy98.7%Clinical Sensitivity98.3%Clinical Specificity100%2010NOVA Test® SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography)924Atlas Link Technology Co., Ltd.Chinahttp://www.atlas-link.com/english/YesCommercialisedYesNoCassetteLateral flowStripManualNear POC / POCAntigenNasal swabOropharyngeal swabOur NOVA Test® SARS-CoV-2 Antigen Rapid Test Kit has been posted on the antigen list of German BfArM, it has also been on the PEI list.2021-05-11 09:29:551688Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich, DoubleColloidal goldValidity test kit15LOD50AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0.6%Fn1.5%PrecisionNot evaluatedAccuracy99.1%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity98.5%Clinical Specificity99.4%Type of antigennucleoprotein1880Ninonasal572NG BiotechFrancengbiotech.com/YesCommercialisedNoNoCassetteManualAntigenN/A2021-05-10 13:04:001559Immuno-AntigenNoImmunoassayQualitativeColorimetry15LOD1AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0.51%(2 false positive result out of 390 negative samples confirmed by RT-PCR)Fn2.34%(3 false negative results out of 128 positive samples confirmed by RT-PCR)PrecisionEvaluatedReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity98%Clinical Specificity99%Type of antigenNucleoprotein1646NG-Test SARS-CoV-2 Ag572NG BiotechFrancengbiotech.com/YesCommercialisedNoNoLateral flowNear POC / POCAntigen2021-05-10 13:04:001327Immuno-AntigenYesNoImmunoassayQualitative15LOD1AUCalibrationevaluatedCrossreactivityevaluatedFp0%0 false positive result out of 100 negative samples confirmed by RT-PCRFn17%17 false negative results out of 100 positive samples confirmed by RT-PCRPrecisionevaluatedReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity87%Clinical Sensitivity83%Clinical Sensitivity95%Type of antigennucleoprotein1162NADAL COVID-19 Ag Test182Nal von minden GmbHGermanywww.nal-vonminden.com/YesCommercialisedYesYesCardLateral flowNear POC / POCAntigenNasal swabSerumWhole blood2021-05-10 13:04:00943Immuno-AntigenYesNoChromatographyQualitative15Clinical Sensitivity97.56%Ct-value: 20-30Clinical Specificity99.9%Type of antigenNucleoprotein1490Multi-Respiratory Virus Antigen Test Kit(Swab) (Influenza A+B/ COVID-19)546Safecare Biotech (Hangzhou) Co. LtdChinaen.safecare.com.cn/YesCommercialisedYesNoNear POC / POCAntigenNasal swab2021-05-10 19:40:141235Immuno-AntigenYesNoImmunoassayQualitativeColorimetry10FP: FluA:0, FluB:0. FN: FluA:0.56%, FluB: 0. Accuracy: FluA:99.54%, FluB:100%. Clinical Sensitivity: FluA:100%, FluB:100%.LOD1.5AU1.5CalibrationevaluatedCrossreactivityevaluatedFp2.96%COVID-19Fn0.56%COVID-19PrecisionevaluatedAccuracy98.41%COVID-19:ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity97.04%COVID-19Type of antigennucleoprotein1779mö-screen Corona Antigen Testr532möLabGermanywww.moelab.de/startseite.htmlYesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swabNasopharyngeal swab2021-05-10 13:18:201458Immuno-AntigenYesNoImmunochromatographyQualitative15LOD115U/mlCalibrationEvaluatedCrossreactivityEvaluatedFp0.23%2 of 865Fn0.35%3 of 865PrecisionEvaluatedAccuracy99.42%RobustnessEvaluatedClinical Sensitivity98.32%Type of antigenNucleoprotein1775MEXACARE COVID-19 Antigen Rapid Test794MEXACARE GmbHGermanywww.mexacare.comYesCommercialisedNoNoCassetteLateral flowNear POC / POCAntigenNasal swab2021-05-10 13:04:001454Immuno-AntigenYesNoChromatographyQualitative20LOD1300TCID50/mlCalibrationNot EvaluatedCrossreactivityEvaluatedFp4.35%5 of 115Fn0.62%2 of 321PrecisionEvaluatedAccuracy98.39%ReproducibilityEvaluatedRobustnessEvaluatedClinical SensitivityEvaluatedClinical Sensitivity95.65%Type of antigenNucleoprotein1180MEDsan SARS-CoV-2 Antigen Rapid Test617MEDsan GmbHGermanywww.medsan.eu/en/YesCommercialisedYesYesLateral flowNear POC / POCAntigenNasopharyngeal swabOropharyngeal swab2021-05-10 20:07:30961Immuno-AntigenYesNoImmunoassayQualitative15LOD14.4TCID50/mlAccuracy98.4%Clinical Sensitivity92.5%Clinical Specificity99.8%1749Mednano840Wuhan NanoDiagnosis for Health Biotechnology Co., LtdChinandh-biotech.comYesCommercialisedNoNoNear POC / POCAntigen2021-05-10 13:18:201427Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD3581.5AUCrossreactivity0AUFp1AUFn0AUPrecision0AUAccuracy100%Clinical Sensitivity96.88%1969MediPort Limited35Beijing Beier Bioengineering Co., LtdChinawww.mediport.comYesCommercialisedNoNoCardManualNear POC / POCAntigenAnterior nasal swabNasal swabOtherType of antigens S1, S1-RBD, S2, N proteins2021-05-10 13:04:001645Immuno-AntigenNoImmunoassayQualitative15LOD130AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0AUFn0AUPrecisionNot evaluatedAccuracy98.5%ReproducibilityNot evaluatedRobustnessNot evaluatedClinical Sensitivity96.5%(95% CI: 93.7%~99.3%)Clinical Specificity99.8%Type of antigenNucleoprotein721Maverick SARS-CoV-2 Multi-Antigen Serology Panel442GenalyteUnited Stateswww.genalyte.com/NoCommercialisedNoNoLab-basedAntigenWhole blood2021-05-10 13:04:00601Immuno-AntigenYesImmunoassaySemiquantitativePhosphor technology20Serological panel, Photonic ring resonance Accuracy98%Clinical Sensitivity87%Clinical Specificity100%Type of antigenSARS-CoV-21882MAUVE COVID-19 Ag Test861InTelos, Inc.South Koreawww.intelos.co.krYesCommercialisedNoNoCassetteNear POC / POCAntigenNasopharyngeal swabOropharyngeal swabAntigen Rapid Diagnostic Test2021-05-10 13:04:001561Immuno-AntigenNoImmunoassayQualitativeMagnetic ElectrochemicalN.A.15LOD5.8%CalibrationEvaluatedCrossreactivityEvaluatedFp0%Fn10%PrecisionEvaluatedAccuracy95%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90%Clinical Specificity100%Type of antigenNucleoprotein1234MARK-B COVID-19 Ag S629BBB INC; Obelis S.A.(BE)South Koreawww.bbbtech.com/YesCommercialisedNoNoOtherAntigenNasopharyngeal swab2021-05-10 13:04:001016Immuno-AntigenYesYesImmunoassayQualitativePhotonic ring resonance10Atomated Sandwich, Magnetic Electrochemical LOD24TCID50/mlClinical Sensitivity98.5%Clinical Specificity98.5%768mariPOC SARS-CoV-2454ArcDia International LtdTurkeywww.arcdia.comYesCommercialisedNoNoMicroplateNear POC / POCAntigenNasopharyngeal swab2021-05-10 13:04:00622Immuno-AntigenYesYesImmunoassayQuantitativeFluorescence20Crossreactivity0 with MERS, seasonal coro-naviruses (229E, HKU1, NL63, OC43) or other common respiratory tract pathogens or normal bacterial floraClinical Sensitivity92%Clinical Specificity100%1215LYHER Novel Coronavirus (COVID-19) Antigen Test Kit(Colloidal Gold)302Hangzhou Laihe Biotech Co., LtdChinawww.lyherbio.com/YesCommercialisedYesNoCassetteNear POC / POCAntigenNasal swab2021-05-10 19:40:131041Immuno-AntigenYesNoImmunoassayQualitativeColloidal gold1268LumiraDx SARS-CoV-2 Ag Test252LumiraDXUnited Kingdomwww.lumiradx.comYesCommercialisedYesYesStripNear POC / POCAntigenNasal swab2021-05-10 13:18:201043Immuno-AntigenYesNoImmunoassayQualitativeFluorescence12LOD32TCID50/mlClinical Sensitivity97.6%Clinical Specificity96.6%Type of antigennucleocapsid1667LooK SPOT746Laipac Technology Inc.Canadawww.laipac.comYesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swab2021-05-10 13:04:001346Immuno-AntigenYesYesImmunoassayQualitativeColorimetry5LOD2600000AUCalibrationevaluatedCrossreactivityevaluatedFp2%Limited to less than 2%Fn3%Limited to less than 3%PrecisionevaluatedAccuracy95%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity97.4%Type of antigennucleoprotein1442Livzon Test for SARS-CoV-2 Antigen (Fluorescence Immunochromatographic Assay)225Zhuhai Livzon Diagnostics IncChinawww.livzondiagnostics.com/en-us/list/39.htmlYesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swab2021-05-10 13:04:001193Immuno-AntigenYesYesImmunoassayQualitativeFluorescence15Rapid diagnostic test lateral flow fluorescence LOD100AU100CalibrationevaluatedCrossreactivityevaluatedPrecisionevaluatedAccuracynot foundReproducibilityevaluatedRobustnessnot evaluatedClinical Sensitivity97%Clinical Specificity98.3%Type of antigennucleoprotein1441Livzon Rapid Test for SARS-CoV-2 Antigen (Lateral Flow)225Zhuhai Livzon Diagnostics IncChinawww.livzondiagnostics.com/en-us/list/39.htmlYesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swab2021-05-10 13:04:001192Immuno-AntigenYesNoImmunoassayQualitative15LOD100%CalibrationevaluatedCrossreactivityevaluatedPrecisionevaluatedAccuracynot foundReproducibilityevaluatedRobustnessnot evaluatedClinical Sensitivity90.9%Clinical Specificity100%Type of antigennucleoprotein1863LionRun™️SARS-CoV-2 Antigen Rapid Test Kit (Lateral Flow Immunoassay)853Shanghai Liangrun Biomedicine Technology Co., Ltd.Chinawww.liangrunbio.com/en/indexYesCommercialisedNoNoCassetteNear POC / POCAntigenOropharyngeal swabLionRunTM SARS-CoV-2 Antigen Rapid Test (Lateral Flow Immunoassay) uses microsphere immunochromatography technology which is intended for the in vitro qualitative detection of the SARS-CoV-2 virus antigen nucleocapsid (N) protein in human nasal swab, nasopharyngeal swab, oropharyngeal swab samples.2021-05-10 13:04:001540Immuno-AntigenN.A.ImmunoassayQualitativeElectrochemiluminescenceN.A.10LODAU25CalibrationEvaluatedCrossreactivityEvaluatedFp11Fn88PrecisionEvaluatedAccuracy96.89%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92%Clinical Specificity99.33%1960LIAISON® SARS-CoV-2 Ag (311490)511DiaSorin S.p.AItalywww.diasorin.com/YesCommercialisedNoNoCardAutomatedLab-basedAntigenNasal swabNasopharyngeal swabThe method for quantitative determination of SARS-CoV-2 Ag in specimens collected and processed through the indicated pre-analytical procedure, is a direct two-step sandwich chemiluminescence immunoassay (CLIA). Specific rabbit polyclonal antibodies to nucleocapsid antigen are used for coating magnetic particles (solid phase) and linked to an isoluminol derivative (isoluminol-antibody conjugate). During the first incubation, SARS-CoV-2 viral antigen present in calibrators, samples or controls binds to the conjugate. During the second incubation, the solid phase reacts with the SARS-CoV-2 viral antigen already bound to the conjugate. After the second incubation, the unbound material is removed with a wash cycle. Subsequently, the starter reagents are added, and a flash chemiluminescence reaction is thus induced. The light signal, and hence the amount of isoluminol-antibody conjugate, is measured by a photomultiplier in relative light units (RLU) and is directly proportional to the SARS-CoV-2 viral antigen concentration present in calibrators, samples, or controls.2021-05-10 13:18:201636Immuno-AntigenYesCLIAQuantitativeSandwichChemiluminescence42LOD22AUCalibrationEvaluatedCrossreactivityEvaluatedPrecisionEvaluatedAccuracy99%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99%Clinical Specificity98%Type of antigennucleocapside protein257Leadgene SARS/SARS-CoV-2 Antigen Rapid Test Kit157Leadgene Biomedical, IncTaiwan ROCwww.leadgenebio.com/NoIn developmentNoNoNear POC / POCAntigenNasal swab2021-05-10 13:04:00208Immuno-AntigenYesImmunoassayQualitative151605Lab-On-Time COVID-19 Antigen Rapid Test Device (Integrated Throat Swab)611BMT DiagnosticsIsraelwww.bmtdiagnostics.comYesCommercialisedNoNoNear POC / POCAntigenOtherThroat swab no info on website about preformance 2021-05-10 13:04:001286Immuno-AntigenYesNoImmunoassayQualitative15Rapid diagnostic test Dipstick LOD1000AUCalibrationevaluatedCrossreactivityevaluatedFp2.43%3 of 123Fn1.23%1 of 81PrecisionevaluatedAccuracy98%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity96.4%Type of antigennucleoprotein1322Kwork Covid-19 Ag Rapid Test Device(Saliva/Sputum/Feces)648Zhejiang Quark Biotechnology Co., LtdChinawww.zjkuake.comYesCommercialisedNoNoNear POC / POCAntigenSaliva2021-05-10 13:04:001088Immuno-AntigenYesNoImmunoassayQualitative15Accuracy96.7%Clinical Sensitivity90%1800Ksmart® SARS-COV2 Antigen Rapid Test820AVALUN SASFranceavalun.com/YesCommercialisedNoNoSemi-automatedAntigenNasopharyngeal swab2021-05-10 13:04:001479Immuno-AntigenYesImmunochromatographyQualitativeColorimetry20LOD30U/mlCalibrationNot evaluatedCrossreactivityEvaluatedFp0.68%The specificity was tested using 441 negative specimens.3 False positives results vs the PCR assayFn6.81%The sensitivity was tested using 176 positive specimens.12 False negatives results vs the PCR assay.PrecisionEvaluatedAccuracy97.57%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity93.18%Clinical Specificity99.32%1285Kewei COVID-19 Antigen Rapid Test Kit (Fluorescence)43Beijing Kewei Clinical Diagnostic Reagent IncChinaen.keweidiagnostic.com/YesCommercialisedNoNoNear POC / POCAntigenNasal swabThroat swab2021-05-10 13:04:001059Immuno-AntigenYesImmunoassayQualitativeFluorescence15Rapid diagnostic test Lateral Flow fluorescence Clinical Sensitivity85%Clinical Specificity100%Type of antigennucleocapsid70Kewei COVID-19 Antigen Rapid Test Kit (FIA)43Beijing Kewei Clinical Diagnostic Reagent IncChinaen.keweidiagnostic.com/YesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swabOropharyngeal swab2021-05-10 13:04:00390Immuno-AntigenYesYesImmunoassayQualitativeFluorescence15LOD140TCID50/mlAccuracy97.5%Clinical Sensitivity85%Clinical Specificity100%1284Kewei COVID-19 Antigen Rapid Test Kit (Colloidal Gold)43Beijing Kewei Clinical Diagnostic Reagent IncChinaen.keweidiagnostic.com/YesCommercialisedNoNoNear POC / POCAntigenNasal swabThroat swab2021-05-10 13:04:001058Immuno-AntigenYesImmunoassayQualitativeColorimetry15Rapid diagnostic test Lateral Flow Clinical Sensitivity85%Clinical Specificity100%Type of antigennucleocapsid244KDx COVID-19 Antigen Detection Rapid Test149Kephera DiagnosticsUnited Stateswww.kephera.com/NoIn developmentNoNoNear POC / POCAntigen2021-05-10 13:04:00195Immuno-AntigenYesImmunoassay1725Jinwofu® Novel Coronavirus (SARS-CoV-2) Antigen-Rapid-Test765Beijing Jinwofu Bioengineering Technology Co.,LtdChinawww.jwfbio.com/en/YesCommercialisedNoNoCardNear POC / POCAntigenNasal swabOther2021-05-10 13:04:001405Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD100CalibrationevaluatedCrossreactivityevaluatedFp0AUFn10AUPrecisionevaluatedAccuracy98.82%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity96.88%Type of antigennucleoprotein2056iSIA947Chongqing iSIA Bio-Technolgy Co. LtdChinawww.isiabio.com.cnYesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabSalivaBfArM listed2021-05-17 09:34:181736Immuno-AntigenYesImmunoassaySandwich, DoubleSample collection device10LOD0.1AUCalibrationEvaluatedCrossreactivityEvaluatedFp12AUFn16AUPrecisionEvaluatedAccuracy97%ReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity96%Clinical Specificity97%Type of antigenNucleoprotein1678Instant-view® PLUS COVID-19 Antigen Test17Alfa Scientific Designs IncUnited Stateswww.alfascientific.com/YesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swab2021-05-10 13:18:201357Immuno-AntigenYesNoImmunoassayQualitative3LOD2800AUCalibrationnot evaluatedCrossreactivityevaluatedFp3 out of 171Fn3 out of 40Precisionnot evaluatedAccuracy97.2%ReproducibilityevaluatedRobustnessnot evaluatedClinical Sensitivity92.5Type of antigennucleoprotein1444Instant SARS-CoV-2 Rapid Ag Test678Vitrosens Biotechnology Co., LtdTurkeywww.vitrosens.comYesCommercialisedNoNoDipstickNear POC / POCAntigenNasal swabOtherSaliva2021-05-10 13:18:201195Immuno-AntigenYesNoImmunoassayQualitativeColorimetry5LOD100IU/mlCalibrationevaluatedCrossreactivityevaluatedFp1AUFn1AUPrecisionevaluatedAccuracy98.3%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity97.3%Type of antigennucleoprotein1931Influenza A/B/Corona Virus (COVID-19) Antigen Rapid Test (Colloidal Gold)883Hoyotek Biomedical Co.,LtdChinahoyotek.cn/index.htmlYesCommercialisedNoNoManualAntigenNasopharyngeal swabOropharyngeal swabSalivaThe product is based on the principle of sandwich and colloidal gold immunochromatography, the nitrocellulose membrane Test Zone is pre-coated with mouse anti-Influenza A/B/Corona Virus (COVID-19) monoclonal antibody, the Control Zone is pre-coated with goat anti-mouse polyclonal antibody, the gold conjugation pad is pre-coated with colloidal gold labeled mouse anti-Influenza A/B/Corona Virus (COVID-19) monoclonal antibody. When testing positive samples, Influenza A/B/COVID-19 Antigen the sample will be combined with colloidal gold (Au) labeled mouse anti-Influenza A/B/Corona Virus (COVID-19) monoclonal antibody and form into immune complexes (Au-mouse anti-Influenza A/B/Corona Virus (COVID-19) monoclonal antibody-[ Influenza A/B/COVID-19- (Antigen)]), the complexes will move forward inside the nitrocellulose membrane by chromatography effect. When reaching Test Zone, the complexes will be combined with mouse anti-Influenza A/B/Corona Virus (COVID-19) monoclonal antibody, and form into “(Au-mouse anti-Influenza A/B/Corona Virus (COVID-19) monoclonal antibody-[COVID-19- (Antigen)])-[ mouse anti-Influenza A/B/Corona Virus (COVID-19) monoclonal antibody]”, thus agglutination color appears; The residual colloidal gold labeled mouse anti-Influenza A/B/Corona Virus (COVID-19) monoclonal antibody will be combined with goat anti-mouse polyclonal antibody at the Control Zone, and produce color under agglutination. When testing negative samples, there’s no Influenza A/B/COVID-19 Antigen in the samples, no immune complexes will be formed and color only appears in the Control line.2021-05-10 13:04:001607Immuno-AntigenNoImmunochromatographyQualitativeSandwichColloidal goldOther15LOD5.25AUCalibrationNot evaluatedCrossreactivityEvaluatedFp1%2%(FluA); 1.5%(FluB)Fn4%6%(FluA); 8%(FluB)PrecisionEvaluatedAccuracy98.497.5%(FluA); 95.3%(FluB)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96%94%(FluA); 92.1%(FluB)Clinical Specificity99%98%(FluA); 98.5(FluB)Type of antigenOther1301Influenza A+B Antigen Test Kit (Colloidal Gold)851Nantong Diagnos Biotechnology Co., LtdChinawww.diagnosbio.comYesCommercialisedNoNoNear POC / POCAntigenNasal swab2021-05-10 13:18:201071Immuno-AntigenYesYesImmunoassayQualitative15LOD0.05AUAccuracy97.6%Clinical Sensitivity96.67%Type of antigenNucleoprotein1845Immunobio SARS-CoV-2 Antigen SPUTUM Rapid Test Kit (non invasive)624Zhejiang Anji Saianfu Biotech Co., LtdChinawww.seinofy.comYesCommercialisedNoNoCassetteManualAntigenOropharyngeal swabSputumThroat secretionThroat swabBfArM Listed, PEI evaluated2021-05-10 13:18:201524Immuno-AntigenImmunoassay1844Immunobio SARS-CoV-2 Antigen ANTERIOR NASAL Rapid Test Kit (minimal invasive)843Hangzhou Immuno Biotech Co.,LtdChinawww.jg-biotech.com/YesCommercialisedYesNoCassetteManualAntigenNasal swabNasopharyngeal swabBfArM Listed, PEI evaluated2021-05-10 19:40:141521Immuno-AntigenYesNoImmunochromatographyQualitative10LOD6AUCalibrationEvaluatedCrossreactivityEvaluatedFp5.61%94,39Fn0%100PrecisionEvaluatedAccuracy97.67%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94%Clinical Specificity100%Type of antigenNucleoprotein1928ImmTek COVID-19 Antigen Rapid Test882Metas Biomedical Inc.Taiwan ROCwww.metasbiomedical.comYesCommercialisedNoNoCassetteStripNear POC / POCAntigenNasal swabNasopharyngeal swabMade in Taiwan2021-05-10 13:04:001604Immuno-AntigenNoImmunochromatographyQualitativeSandwich10LOD313AUCalibrationEvaluatedCrossreactivityEvaluatedFp1.79AUFn9.38AUPrecisionEvaluatedAccuracy95.45%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90.62%Clinical Specificity98.21%Type of antigenNucleoprotein1169iFlash-2019-nCoV Antigen379SHENZHEN YHLO BIOTECH CO., LtdChinawww.szyhlo.comYesCommercialisedNoNoAutomatedManualAntigenNasal swabNasopharyngeal swab2021-05-10 13:04:00948Immuno-AntigenYesImmunoassayQualitativeChemiluminescenceType of antigenSpike protein1728iD Rapid® COVID-19 Antigen766Innovative DiagnosticsFrancewww.innovative-diagnostics.com/YesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swab2021-05-10 13:04:001408Immuno-AntigenYesNoImmunoassayQualitative15LOD1800AUCalibrationnot evaluatedCrossreactivityevaluatedFp0%Fn2.47%2 false negative on 81 samples tested positive by PCRPrecisionevaluatedAccuracy96.9%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity97.7%1990ichroma™ COVID-19 Ag22Boditech Med IncSouth Koreawww.boditech.co.kr/eng/YesCommercialisedNoNoCartridgeNear POC / POCAntigenNasopharyngeal swabFIND https://www.finddx.org/sarscov2-eval-antigen/ Germany https://www.sciencedirect.com/science/article/pii/S13866532210006392021-05-10 13:18:201666Immuno-AntigenYesImmunoassayQualitativeMembrane-basedOther12LOD35.15AUCalibrationEvaluatedCrossreactivityEvaluatedFpRequire clinical data comparisonFnRequire clinical data comparisonPrecisionEvaluatedAccuracy95.2%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity90.9%Clinical Specificity98.7%Type of antigenNucleoprotein107Ichroma COVID-19, viral Antigen22Boditech Med IncSouth Koreawww.boditech.co.kr/eng/YesCommercialisedNoNoCartridgeManualAntigen2021-05-10 13:04:0075Immuno-AntigenImmunoassay1448ichroma COVID-19/Flu Ag Combo22Boditech Med IncSouth Koreawww.boditech.co.kr/eng/YesCommercialisedNoNoAutomatedManualAntigenNasal swab2021-05-10 13:04:001198Immuno-AntigenYesImmunoassayQualitativeFluorescence20Accuracy: 98.1 (Flu A) 98.1 (Flu B). Clinical sensitivity 93.8 (Flu A) 93.8 (Flu B)LOD55IU/mlCalibrationevaluatedCrossreactivityevaluatedPrecisionevaluatedAccuracy98.6%(antigen) ReproducibilityevaluatedRobustnessnot evaluatedClinical Sensitivity100% (antigen)Type of antigennucleoprotein1262Humasis COVID-19/Flu Ag Combo Test140HumasisSouth Koreawww.humasis.com/en/YesCommercialisedNoNoCassetteNear POC / POCAntigenNasopharyngeal swab2021-05-10 13:04:001037Immuno-AntigenYesImmunoassayQualitative151263Humasis COVID-19 Ag Test140HumasisSouth Koreawww.humasis.com/en/YesCommercialisedYesYesNear POC / POCAntigenNasal swab2021-05-10 20:07:301038Immuno-AntigenYesImmunochromatographyQualitative15Rapid diagnostic test cassette LOD0AUFp0%Fn5.6%Accuracy97.4%Clinical Sensitivity95.3%2057Gruenbanka SARS-CoV-2 Antigen Testkit948Xiamen Jiqing Biomedical Technology Co. LtdChinawww.wikang.com.cnYesCommercialisedNoNoCassetteNear POC / POCAntigenAnterior nasal swabNasal swabNasopharyngeal swabOropharyngeal swabSalivaSputumwww.gruenbanka.eu2021-05-17 09:41:181737Immuno-AntigenImmunoassaySandwich, DoubleOther10LOD10AUCalibrationEvaluatedCrossreactivityEvaluatedFp6AUFn0%PrecisionEvaluatedAccuracy97%ReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity94%Clinical Specificity100%Type of antigenNucleoprotein1854Gmate® COVID-19 Ag Saliva715Philosys Co., Ltd.South Koreawww.philosys.comYesCommercialisedNoNoCartridgeManualAntigenSalivaN.A2021-05-10 13:04:001534Immuno-AntigenYesNoImmunoassayQualitativeColorimetryN.A.15LOD5.07AUCalibrationNot evaluatedCrossreactivityEvaluatedFp-Fn-PrecisionEvaluatedAccuracy98.87%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.83%Clinical Specificity99.6%Type of antigenNucleoprotein1611Gmate® COVID-19 Ag715Philosys Co., Ltd.South Koreawww.philosys.comYesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swab2021-05-10 13:04:001291Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD5.07U/mlCalibrationNot EvaluatedCrossreactivityEvaluatedPrecisionEvaluatedAccuracy96.67%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity91.11%1893GLINE-2019-nCoV Ag Saliva379SHENZHEN YHLO BIOTECH CO., LtdChinawww.szyhlo.comYesCommercialisedNoNoCassetteManualAntigenSalivaThe unit of LoD value is different from the blank above. The LoD value : 4.25×100 TCID50/mL2021-05-10 13:04:001347GLINE-2019-nCoV Ag379SHENZHEN YHLO BIOTECH CO., LtdChinawww.szyhlo.comYesCommercialisedNoNoManualNear POC / POCAntigenNasal swabNasopharyngeal swab2021-05-10 13:04:001253GenSure COVID-19 Antigen Rapid Kit (REF: P2004)340GenSure Biotech IncChinawww.gensbio.com/YesCommercialisedYesNoNear POC / POCAntigenNasal swab2021-05-10 19:40:141029Immuno-AntigenYesImmunoassay151593GeneFinder COVID-19 Ag Rapid Test702OSANG Healthcare Co., LtdSouth Koreawww.osanghc.com/YesCommercialisedNoNoCassetteNear POC / POCAntigen2021-05-10 13:04:001273Immuno-AntigenYesNoImmunoassayQualitative15LOD0AUCalibrationnot evaluatedCrossreactivityevaluatedReproducibilityevaluatedRobustnessnot evaluatedClinical Sensitivity96.7%(PPA)Type of antigennucleoprotein1144GENEDIA W COVID-19 Ag600Green Cross Medical Science Corp.South Koreawww.greencrossms.com/eng/main.do?lang=ENYesCommercialisedYesYesCassetteNear POC / POCAntigenAnterior nasal swabNasopharyngeal swab2021-05-11 09:31:09921Immuno-AntigenYesNoImmunoassayQualitative10LOD750TCID50/mlCalibrationEvaluatedCrossreactivityEvaluatedFpNot foundFnNot foundPrecisionEvaluatedAccuracy95.3%RobustnessEvaluatedClinical Sensitivity100%Clinical Sensitivity90.1%Type of antigenNucleoprotein1297GenBody FIA COVID-19 Ag97GenBody, IncSouth KoreaYesCommercialisedNoNoCassetteNear POC / POCAntigenNasopharyngeal swabOropharyngeal swab2021-05-10 13:04:001067Immuno-AntigenYesNoImmunoassayQualitative20LOD898TCID50/mlAccuracy92.95%Clinical Sensitivity89.47%Clinical Specificity96.43%1244Genbody COVID-19 Ag Test97GenBody, IncSouth KoreaYesCommercialisedYesNoCassetteNear POC / POCAntigenNasopharyngeal swabOropharyngeal swab2021-05-10 13:04:001025Immuno-AntigenYesNoImmunoassayQualitativeSandwich, Double20LOD2870TCID50/mlAccuracy94%Clinical Sensitivity90%Clinical Specificity98%1585GenaBio SARS-CoV-2 Antigen Lateral Flow Test698GenaBio Diagnostics Inc.United Stateswww.genabio.comYesCommercialisedNoNoCassetteLateral flowNear POC / POCAntigenNasal swab Issue between the data (colloidal gold and the website link provided: immunofluorescence 2021-05-10 13:04:001265Immuno-AntigenYesNoImmunoassayQualitativeColloidal gold15LOD1AUCalibrationevaluatedCrossreactivityevaluatedFp4.93%Fn0.26%PrecisionevaluatedReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity95.07%(Antigen)Type of antigennucleoprotein1855GA CoV-2 Antigen Rapid Test351GA Generic Assays GmbHGermanywww.genericassays.comYesCommercialisedNoNoLateral flowManualAntigenNasopharyngeal swabGA CoV-2 Antigen Rapid Test is used for the qualitative determination of SARS-Coronavirus 2 (COVID-19) Antigen in human nasopharynx specimen. The test is intended for use by trained clinical laboratory personnel.2021-05-10 13:04:001535Immuno-AntigenNoImmunochromatographyQualitativeMembrane-basedN.A.15LOD10AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0.8%4/500Fn2.94%3/102PrecisionEvaluatedAccuracy98%ReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity97.059%Clinical Specificity99.2%Type of antigenNucleoprotein1580GA CoV-2 Antigen Rapid351GA Generic Assays GmbHGermanywww.genericassays.comYesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swab in instruction manual: Limit of detection: 100 pg/ml of the recombinant protein 2021-05-10 13:04:001259Immuno-AntigenYesNoImmunoassayQualitative15LOD70AUCalibrationnot evaluatedCrossreactivityevaluatedFp3.6%(It was compared with results of the RT-PCR reference method and found a sensitivity 96.4%)Fn0.8%(It was compared with results of the RT-PCR reference method and found a specificity 99.2%)Precision99%99%]]>Accuracy98%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity96.4%Clinical Specificity99.2%Type of antigennucleoprotein1420FREND COVID-19 Ag354NanoEntekSouth Koreawww.nanoentek.comYesCommercialisedYesNoCartridgeAutomatedNear POC / POCSemi-automatedAntigenNasopharyngeal swab2021-05-10 19:40:141180Immuno-AntigenYesYesImmunoassayQualitativeFluorescence3Microfluidic testLOD0.01AUCalibrationEvaluatedCrossreactivity0%for tested agentsFp0%Fn5.9%PrecisionEvaluatedAccuracy94.12%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.12%Clinical Sensitivity94.12%Clinical Specificity100%Clinical Specificity100%Type of antigenCOVID-19 Nucleocapsid protein1208Formosa One Sure SARS-CoV-2 Ag Rapid Test Kit626Formosa Biomedical Technology Corp.Taiwan ROCwww.fbc.com.tw YesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swab2021-05-10 13:04:00993Immuno-AntigenYesNoImmunoassayQualitative15Clinical Sensitivity88%1192FORA COVID-19 Antigen Rapid Test588TaiDoc Technology Corp.Taiwan ROCtaidoc.com/YesCommercialisedNoNoLateral flowNear POC / POCAntigenNasopharyngeal swab https://www.testlinecd.com/file/1580/COVID-19_AN_NEW%20(002).pdf?version=202008131535 https://www.foracare.ch/covid-19-Antigen-rapid-test/; https://www.foracare.ch/wp-content/uploads/2020/11/20201104_FORA_TD-4531_Covid-19_quick-user-guide_EN_V3.pdf2021-05-10 13:04:00978Immuno-AntigenYesImmunoassayQualitativeMagnetic Electrochemical15LOD126TCID50/mlClinical Sensitivity91.3%Clinical Specificity98.6%Type of antigennucleocapsid recombinant Antigen1664FluCov2529DyonMed SAGreecedyonmedical.com/en/home/YesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swab2021-05-10 13:04:001343Immuno-AntigenYesNoImmunoassayQualitative15LOD1AUCalibrationevaluatedCrossreactivityevaluatedFp7.75%Compared to PCR (n=142) 11 FPFn0%Compared to PCR (n=66) no false negativesPrecisionevaluatedAccuracy95%(Antigen)ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity92.25%(Antigen)Type of antigennucleoprotein1370FLUA-FLUB-RSV-ADV-COVID-19 Combo Test Device455Assure Tech. (Hangzhou) Co., LtdChinawww.diareagent.com/YesCommercialisedNoNoNear POC / POCAntigenOther immunochromatography?2021-05-10 13:04:001141Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15Rapid diagnostic test colloidal gold LOD2102.4AUFpNot availableFnNot availableAccuracy98.5%(COVID-19:98.5%; Influenza A:88.4%, Influenza B:88.9%, RSV:97.4%, Adenovirus:96.3%)Clinical Sensitivity97.3%(COVID-19:97.3%; Influenza A:83.3%, Influenza B:82.4%, RSV:96.2%, Adenovirus:95.2%)1470Flu+COVID-19 Ag Test Kit655Guangdong Wesail Biotech Co., LtdChinaen.wesailbio.comYesCommercialisedNoNoNear POC / POCAntigenNasal swab2021-05-10 13:04:001217Immuno-AntigenYesNoImmunoassayQualitativeColloidal gold15LOD560AUCalibrationNot evaluatedCrossreactivityevaluatedFp10Fn0.8PrecisionevaluatedAccuracy95.6%Reproducibilitynot evaluatedRobustnessnot evaluatedClinical Sensitivity91.1%1713Flu A/Flu B/SARS-CoV-2 Antigen (GICA)761MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.Chinawww.medcaptain.comYesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swab2021-05-10 13:04:001393Immuno-AntigenYesNoImmunoassayQualitativeColloidal gold15LOD1250AUCalibrationnot evaluatedCrossreactivityevaluatedFp1.9%Fn2.8%PrecisionevaluatedAccuracy98%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity97.2%(Antigen)Type of antigennucleoprotein1468Flowflex SARS-CoV-2 Antigen rapid test683ACON Laboratories, IncUnited Stateswww.aconlabs.comYesCommercialisedYesYesCassetteLateral flowNear POC / POCAntigenNasal swab2021-05-10 20:07:301219Immuno-AntigenYesNoImmunochromatographyQualitative15LOD160U/mlCalibrationNot EvaluatedCrossreactivityEvaluatedFp0.5%Fn3.1%PrecisionEvaluatedAccuracy98.8ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.9Type of antigenNucleoproteinType of antigennucleoprotein1724First Sign SARS-CoV-2-Antigen-Test726WHPMUnited Stateswww.whpm.comYesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swab2021-05-10 13:04:001404Immuno-AntigenYesNoImmunoassayQualitative15LOD160000AUCalibrationnot evaluatedCrossreactivityevaluatedFp98.82%2/170Fn98.82%2/170PrecisionevaluatedAccuracy97.6%AntigenReproducibilitynot evaluatedRobustnessevaluatedClinical Sensitivity94.6%AntigenType of antigennucleoprotein1669FIAflex SARS-CoV-2 Antigen FIA565Acon Biotech (Hangzhou) Co., LtdChinawww.aconbio.com/YesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swab2021-05-10 13:18:201348Immuno-AntigenYesNoImmunoassayQualitative15LOD95AUCalibrationnot evaluatedCrossreactivityEvaluatedPrecisionevaluatedAccuracy98.9%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity97.5%Type of antigennucleoprotein1670FIAflex SARS-CoV-2 Antigen FIA683ACON Laboratories, IncUnited Stateswww.aconlabs.comYesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swab2021-05-10 13:04:001349Immuno-AntigenYesNoImmunochromatographyQualitative15LOD95%Calibrationnot evaluatedCrossreactivityevaluatedPrecisionevaluatedAccuracy98.9%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity97.5%Type of antigennucleoprotein1271Exdia COVID-19 Ag637Precision Biosensor, IncSouth Koreawww.precision-bio.com/en/YesCommercialisedYesNoNear POC / POCAntigenNasopharyngeal swab2021-05-10 13:04:001046Immuno-AntigenYesImmunoassayQualitative20Clinical Sensitivity93.9%Clinical Specificity98%1718Epithod®616 COVID-19 Ag Test Kit763DxGen Corp.South Koreawww.dxgenco.comYesCommercialisedNoNoCassetteAutomatedManualAntigenNasal swab2021-05-10 13:04:001398Immuno-AntigenYesImmunoassayQuantitative3LOD10000AUCalibrationevaluatedCrossreactivityevaluatedFpA measured immunochromatic intensity is larger than cut-off value mainly due to non-specific bindingFnA measured immunochromatic intensity is lower than cut-off value mainly due to limit of sensitivityPrecisionnot evaluatedAccuracy100%(Antigen)Reproducibilitynot evaluated RobustnessevaluatedClinical Sensitivity96%(Antigen)Type of antigennucleoprotein1717Epithod SARS-CoV-2 qAg Test Kit763DxGen Corp.South Koreawww.dxgenco.comYesCommercialisedNoNoCassetteAutomatedManualAntigenNasal swab2021-05-10 13:04:001397Immuno-AntigenYesImmunoassayQuantitative3LOD10000AUCalibrationevaluatedCrossreactivityevaluatedFpA measured immunochromatic intensity is larger than cut-off value mainly due to non-specific bindingFnA measured immunochromatic intensity is lower than cut-off value mainly due to limit of sensitivityPrecisionnot evaluatedAccuracy100%(Antigen)Reproducibilitynot evaluated RobustnessevaluatedClinical Sensitivity96%(Antigen)Type of antigennucleoprotein2032EONBT COVID-19 Antigen935EON Biotechnology LimitedUnited Kingdomwww.eonbt.comYesCommercialisedNoNoCassetteLateral flowManualNear POC / POCAntigenNasopharyngeal swab2021-05-10 13:04:001710Immuno-AntigenImmunochromatographyQualitativeMembrane-based20LOD4AUCalibrationNot evaluatedCrossreactivityEvaluatedFp6.72%Clinical trial of 119 positive samples compared with RTqPCR Test 8 False positives were detectedFn0.58%Clinical trial of 511 negative samples compared with RTqPCR Test 3 False negatives were detectedPrecisionEvaluatedAccuracy99.23%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.2%Clinical Specificity99.41%Type of antigenNucleoprotein90882Creative DiagnosticsUnited Stateswww.creative-diagnostics.com/NoCommercialisedNoNoAutomatedManualAntigen2021-05-10 13:04:00722Immuno-AntigenELISA1739EBS1020, EBS SARS-CoV-2 Ag Rapid Test294Eurobio ScientificFrancewww.eurobio-scientific.com/YesCommercialisedNoNoNear POC / POCAntigenNasal swab2021-05-10 13:04:001417Immuno-AntigenYesYesImmunoassayQualitativeColorimetry10rapid diagnostic test lateral flow colloidal gold LOD95AUCalibrationnot evaluatedCrossreactivityevaluatedFpnot available Fnnot availablePrecisionnot evaluatedReproducibilityevaluatedRobustnessnot evaluatedClinical Sensitivity95.7%[A/(A+C) x 100= 95.7% (95% CI 90.2 98.1%)]Type of antigennucleoprotein1651DyonCovidAg529DyonMed SAGreecedyonmedical.com/en/home/YesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swab2021-05-10 13:04:001332Immuno-AntigenYesNoImmunoassayQualitativeColloidal gold15LOD2000AUCalibrationevaluatedCrossreactivityevaluatedPrecisionevaluatedAccuracy97%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity91%Type of antigennucleoprotein1250Dynamiker SARS-CoV-2 Ag Rapid Test86Dynamiker Biotechnology (Tianjin) Co., LtdChinaen.dynamiker.com/YesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swabOropharyngeal swab2021-05-10 13:04:001028Immuno-AntigenYesImmunoassay101733DROP-TECH768Promoitalia Group SpAItalywww.webpromoitalia.comYesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swabSaliva2021-05-10 13:04:001412Immuno-AntigenYesNoImmunoassayQualitative15LOD320AUCalibrationevaluatedCrossreactivityevaluatedFpBased on the accuracy confirmed by studies, fales positives are not likely to occur.FnBased on the accuracy confirmed by studies, fales negatives are not likely to occur.PrecisionevaluatedAccuracy98%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity92.59%Type of antigennucleoprotein1977Diasia906Diasia Biomedical Technology Co., Ltd.Chinawww.diasia.com.cnYesCommercialisedNoNoAntigenNasal swabThe BFARM list is AT 573/21 The specimen was a nasal swab. LOD (U/ml) = 9.975 x 100 TCID50/mL2021-05-10 13:04:001653Immuno-AntigenImmunoassayColloidal gold15LOD36AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0.7%140 specimens were negative by both test reagent and control reagent, and there is 1 specimen of falFn3.1%128 specimens were positive by both test reagent and control reagent, and there are 4 specimens of fPrecisionNot evaluatedAccuracy98.17%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.97%Clinical Specificity99.29%Type of antigenNucleoprotein1375DIAQUICK COVID-19 Ag Cassette526DIALAB GmbHAustriawww.dialab.at/en/home/YesCommercialisedYesYesCassetteNear POC / POCAntigenNasopharyngeal swab2021-05-10 20:07:301139Immuno-AntigenYesNoImmunoassayQualitativeColloidal gold15Type of antigenSARS-CoV-21274Diagnostic Kit for SARS-CoV-2 Ag (Fluorescence Immunochromatographic Assay)262Sure Bio-Tech (USA) Co., LtdUnited Stateswww.surebiotech.com/YesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swabOropharyngeal swab2021-05-10 13:04:001049Immuno-AntigenYesImmunoassayFluorescence2060Dia Sure COVID-19 Antigen Rapid Test Device950Azure Biotech, Inc.United StatesYesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabLimit of detection (LOD):502.4 TCID50/ml Pathogens detected: SARS-CoV-22021-05-17 10:18:561740Immuno-AntigenNoImmunochromatographyQualitativeSandwich15LOD502.4AUCalibrationEvaluatedCrossreactivityEvaluatedFp0.9%Fn5.7%PrecisionEvaluatedAccuracy98.6%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.3%Clinical Specificity99.1%Type of antigenNucleoprotein145DART COVID-1981DART DiagnosticsPolandwww.dart-diagnostics.com/NoIn developmentNoNoAutomatedManualAntigen2021-05-10 13:04:00101Immuno-AntigenImmunoassay1852DAILY TAMPON846ALLUM SRLItalywww.allumbiotech.comYesCommercialisedNoNoCassetteManualAntigenNasal swabThe performance of the kit was established with 600 direct nasal swabs2021-05-10 13:04:001532Immuno-AntigenNoImmunoassayQualitativeColorimetry15LOD1.6AUCalibrationEvaluatedCrossreactivityEvaluatedFp1%Fn1%PrecisionEvaluatedAccuracy99%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99%Clinical Specificity99%Type of antigenNucleoprotein1867Cromatest COVID-19 Antigen Cassette857LINEAR CHEMICALS, S.L.U.Spainwww.linear.esYesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swabNasopharyngeal swabN/A2021-05-10 13:04:001544Immuno-AntigenNoImmunochromatographyQualitativeColorimetryN.A.20LOD280AUCalibrationEvaluatedCrossreactivityEvaluatedFp0%Fn7.7%PrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.3%Clinical Specificity100%Type of antigenNucleoprotein2009COVISTIX COVID-19 VIRUS Rapid Antigen Detection Test833Zhengzhou Fortune Bioscience Co., LtdChinawww.fortunetest.comYesCommercialisedNoNoCassetteLateral flowNear POC / POCAntigenNasal swabNasopharyngeal swabManufactured for Sorrento Therapeutics, Inc. USA2021-05-10 13:04:001687Immuno-AntigenNoImmunochromatographyQualitativeSandwichExtraction kit20LOD0.01AUCalibrationEvaluatedCrossreactivityEvaluatedFp0%NoneFn3.64%PrecisionEvaluatedAccuracy98.1%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.36%Clinical Specificity100%Type of antigenNucleoprotein1663CovidAg529DyonMed SAGreecedyonmedical.com/en/home/YesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swab2021-05-10 13:04:001342Immuno-AntigenYesNoImmunoassayQualitative15LOD0AUCalibrationevaluatedCrossreactivityevaluatedFp9.4%Compared to PCR (n=117) 11 FPFn0.55%Compared to PCR (n=183) 1 false negativesPrecisionevaluatedAccuracy96%(Antigen)ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity90.59%(Antigen)Type of antigennucleoprotein1778COVID19 Antigen Rapid Test Kit43Beijing Kewei Clinical Diagnostic Reagent IncChinaen.keweidiagnostic.com/YesCommercialisedNoNoCardLateral flowNear POC / POCAntigenNasal swab2021-05-10 13:04:001457Immuno-AntigenYesNoImmunochromatographyQualitativeColorimetry15LOD19.3U/mlCalibrationEvaluatedCrossreactivityEvaluatedFp0%Fn3.82%PrecisionEvaluatedAccuracy98.56%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.18%1833COVID-VIRO837AAZ-LMBFrancewww.covid19aaz.comYesCommercialisedYesYesCassetteNear POC / POCAntigenNasal swabNasopharyngeal swab2021-05-17 11:02:121512Immuno-AntigenYesNoImmunochromatographyQualitativeMembrane-based16LOD1.15AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0%Fn3.4%PrecisionEvaluatedAccuracy98.74ReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity96.6%Clinical Specificity100%Type of antigenNucleoprotein1365COVID-19/Influenza A+B Antigen Combo Rapid Test413Hangzhou Clongene Biotech Co., LtdChinaen.clongene.com/YesCommercialisedYesNoNear POC / POCAntigenNasopharyngeal swab2021-05-10 19:40:141125Immuno-AntigenYesNoImmunoassayQualitative15LOD2300TCID50/mlClinical Sensitivity91%(95% CI: 82.8%-95.6%)Clinical Specificity100%(95% CI: 98.2%-100%)Type of antigenSARcov2, influenza A+B viral nucleoprotein antigens1943COVID-19/Influenza A+ B Antigen Test Kit884Surge Medical Inc.Netherlandswww.surge-on.nl/YesCommercialisedNoNoAntigenNA2021-05-10 13:04:001619Immuno-AntigenImmunoassay15LOD100000AUCalibrationEvaluatedCrossreactivityEvaluatedFp98.1%Fn96.77%PrecisionEvaluatedAccuracy97.79%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.1%Clinical Specificity96.77%Type of antigenNucleoprotein1454COVID-19/Flu A/B Antigen Combo Rapid Test340GenSure Biotech IncChinawww.gensbio.com/YesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swab2021-05-10 13:04:001204Immuno-AntigenYesNoImmunoassayQualitative15Accuracy: 97.5 (Influenza A); 96.9 (Influenza B). Clinical sensitivity: 91.7 (Influenza A); 86.2 (Influenza B)LOD50AUCalibrationNot evaluatedCrossreactivityevaluatedFpThe samples collected were contaminated, do not follow the instructions manual, etc. FnSamples collected contained low levels of the virus, do not follow the instructions manual, etc. PrecisionevaluatedAccuracy98.9%(COVID-19)Reproducibilitynot evaluatedRobustnessnot evaluatedClinical Sensitivity96.9%(COVID-19)Type of antigennucleoprotein1956COVID-19-CHECK-1 Antigen574VEDALABChinawww.vedalab.comYesCommercialisedNoNoCassetteStripManualAntigenNasal swabNasopharyngeal swab2021-05-10 13:04:001632Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich20LOD1AUCalibrationEvaluatedCrossreactivityEvaluatedFpSpecificity 100%FnPrecisionEvaluatedAccuracy95.7%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94%(IC 95%: [86.9 -100])Clinical Specificity100%Type of antigenNucleoprotein1282COVID-19 Viral Antigen Test Kit (ELISA)640Beijing Abace Biology Co., LtdChinawww.abace-biology.com/YesCommercialisedNoNoAutomatedManualAntigen2021-05-10 13:04:001057Immuno-AntigenNoN.A.ELISAManual or automated 1281COVID-19 Viral Antigen Test Kit (Colloidal Gold Immunochromatography)640Beijing Abace Biology Co., LtdChinawww.abace-biology.com/YesCommercialisedNoNoNear POC / POCAntigen2021-05-10 13:04:001056Immuno-AntigenYesImmunochromatographyRapid diagnostic test 1237COVID-19 Viral Antigen Test Kit415CamtechSingaporecovid19-test.com/YesCommercialisedNoNoNear POC / POCAntigenOropharyngeal swab Additional info available only upon request https://covid19-test.com/assets/Camtech_Covid19AntigenTestKit.pdf2021-05-10 13:18:201020Immuno-AntigenYesImmunoassayQualitativeFluorescence20Rapid diagnostic test cassette Fluorescence LODng/mL100 ng/mlAccuracy82.4%Clinical Sensitivity88.66%Clinical Specificity94.55%1958Covid-19 Slide Test896HGH Desinfections und Cosmetique GmbHAustriawww.hgh-group.at/YesCommercialisedNoNoCassetteManualNear POC / POCAntigenSalivaDetects SARS-CoV-2 S antigen and SARS-CoV-2 N antigen2021-05-10 13:04:001634Immuno-AntigenNoImmunoassayOther15LOD1.25AUCalibrationEvaluatedCrossreactivityEvaluatedFp93%(95%CI:83%-95%)Fn100%(95%CI:93%-100%)PrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93%Clinical Specificity100%Type of antigenNucleoprotein1924COVID-19 Salivary Antigen Rapid Test Kit（Colloidal Gold）867Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd.Chinaen.konsung.com/YesCommercialisedNoNoCardManualAntigenSalivaN/A2021-05-10 13:04:001600Immuno-AntigenYesImmunochromatographyQualitativeColorimetryOther15LOD50AUCalibrationNot evaluatedCrossreactivityEvaluatedFp8AUFn5AUPrecisionEvaluatedAccuracy99.03%ReproducibilityNot evaluatedRobustnessNot evaluatedClinical Sensitivity96.3%Clinical Specificity99.34%Type of antigenNucleoprotein1915COVID-19 Saliva Ag Test420Core Technology Co., LtdChinawww.coretests.comYesCommercialisedNoNoCassetteNear POC / POCAntigenSaliva2021-05-10 13:18:201592Immuno-AntigenNoImmunochromatographyQualitativeSandwichN.A.10LOD22.5AUCalibrationEvaluatedCrossreactivityEvaluatedFp0.9%Fn2.4%PrecisionEvaluatedAccuracy98.7%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.6%Clinical Specificity99.1%Type of antigenOther1333COVID-19 Rapid Antigen Test (Colloidal Gold)44Joinstar Biomedical Technology Co., LtdChinawww.joinstar.cnYesCommercialisedYesYesLateral flowNear POC / POCAntigenNasal swab2021-05-10 20:07:301105Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15Fp1.86%From 215 samples tested there were 4 false positivesFn1.39%From 215 samples tested there were 3 false negativesAccuracy97.6%Clinical Sensitivity96.1%Clinical Specificity98.1%Type of antigennucleoprotein1190COVID-19 Rapid Antigen Test532möLabGermanywww.moelab.de/startseite.htmlYesCommercialisedYesNoNear POC / POCAntigenNasopharyngeal swab https://mybio.ie/products/covid-19-rapid-Antigen-test-from-molab-box-of-10-tests-ce-ivd2021-05-10 19:40:13974Immuno-AntigenYesImmunoassayQualitative152034COVID-19 Rapid Antigen Test936Biopanda ReagentsUnited Kingdomwww.biopanda.co.ukYesCommercialisedNoNoCassetteLateral flowManualNear POC / POCAntigenAnterior nasal swabNasal swabNasopharyngeal swabOropharyngeal swabThroat swabThe COVID-19 Rapid Antigen Test is a qualitative lateral flow immunoassay for the detection of SARS-CoV-2 antigen in human nasopharyngeal, anterior nares, and oropharyngeal swab specimens.2021-05-10 13:04:001712Immuno-AntigenNoImmunochromatographyQualitativeSandwich15LOD50AUCalibrationEvaluatedCrossreactivityEvaluatedFp0.4%Fn7.8%PrecisionEvaluatedAccuracy97.7%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.2%Clinical Specificity99.6%Type of antigenNucleoprotein1123COVID-19 nucleoprotein ELISA Kit367MP BiomedicalsUnited Stateswww.mpbio.com/YesCommercialisedNoNoMicrotiter plateAutomatedManualAntigenOtherPlasmaTissue homogenates https://www.mpbio.com/us/covid-19-nucleoprotein-elisa-kit2021-05-10 13:04:00914Immuno-AntigenYesELISAQualitativeMagnetic ElectrochemicalN.A.Crossreactivityreported1838COVID-19 Antigen/FLU A+B Antigen Combo Rapid Test Cassette (Colloidal Gold Method)840Wuhan NanoDiagnosis for Health Biotechnology Co., LtdChinandh-biotech.comYesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabSalivaLOD: SARS-CoV-2 5×10ˆ2.55 TCID50/mL Influenza A(H1N1): 1.0×103 TCID50/ml Influenza A (H3N2):1.0×103 TCID50/ml Influenza A (H1N1pdm09):5.0×103 TCID50/ml Influenza B (Yamagata):1.0×104 TCID50/ml Influenza B (Victoria):1.0×103 TCID50/ml2021-05-10 13:04:001516Immuno-AntigenNoImmunoassayQualitativeColorimetryValidity test kit10LOD3581.5AUCalibrationNot evaluatedCrossreactivityEvaluatedFp1.9%2 false positives in 105 testsFn0.6%2 false negatives in 331 testsPrecisionEvaluatedAccuracy99.08%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity98.1%Clinical Specificity99.4%Type of antigenNucleoprotein1756COVID-19 Antigen/Flu A+B Antigen Combo Rapid Test Cassette840Wuhan NanoDiagnosis for Health Biotechnology Co., LtdChinandh-biotech.comYesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swab2021-05-10 13:18:201434Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD1774TCID50/mlSARS-CoV-2 CalibrationNot evaluatedCrossreactivityEvaluatedFp1AUFn0AUPrecisionEvaluatedAccuracy100AntigenRobustnessNot evaluatedClinical Sensitivity96.88%Antigen1279COVID-19 Antigen Test Kit (Rare Earth Nano Fluorescence Immunochromatography)790Xiamen AmonMed Biotechnology Co., LtdChinawww.amonmed.comYesCommercialisedNoNoNear POC / POCAntigen2021-05-10 13:18:201054Immuno-AntigenYesImmunoassayFluorescenceRapid diagnostic test 1648COVID-19 Antigen Test Kit (Dry Fluorescence Immunoassay)739Lansion Biotechnology Co., Ltd.Chinawww.lansionbio.com/YesCommercialisedNoNoStripNear POC / POCAntigenNasal swab2021-05-10 13:04:001329Immuno-AntigenYesImmunoassayQuantitativeFluorescence15LOD0AUCalibrationevaluatedCrossreactivityevaluatedFp3%Fn2%PrecisionevaluatedAccuracy98%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity95%Type of antigennucleoprotein1353COVID-19 Antigen Test Kit (Colloidal Gold)851Nantong Diagnos Biotechnology Co., LtdChinawww.diagnosbio.comYesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swabNasopharyngeal swabThroat swabkit name COVID-19 Ag test; (2019-nCoV) New coronavirus Antigen test (colloidal gold)2021-05-10 13:18:201127Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD0.05Accuracy96%(Antigen)Clinical Sensitivity92.59%(Antigen)Type of antigennucleoprotein1700COVID-19 Antigen Test Cassette (For Analyzer)890Acro Biotech IncUnited Stateswww.acrobiotech.comYesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swab2021-05-10 13:18:201380Immuno-AntigenYesYesImmunoassayQualitative10LOD0AUCalibrationevaluatedCrossreactivityevaluatedFp6.7AUFn1.6AUPrecisionevaluatedAccuracy96.2(Antigen)ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity93.3%(Antigen)Type of antigennucleoprotein1254COVID-19 Antigen Test cassette (FIA)126Hangzhou AllTest Biotech Co., LtdChinawww.alltests.com.cn/YesCommercialisedNoNoCassetteNear POC / POCAntigenNasopharyngeal swab2021-05-10 13:04:001030Immuno-AntigenYesImmunoassayQualitativeFluorescence15FIA method1392COVID-19 Antigen Test Cassette131Hangzhou Testsea Biotechnology Co., LtdChinawww.testsealabs.com/YesCommercialisedYesNoCassetteNear POC / POCAntigenNasal swab2021-05-10 19:40:141158Immuno-AntigenYesNoImmunoassayQualitative10LOD0.1AUCalibrationNot evaluatedFp2AUFn8AUAccuracy96.5%Clinical Sensitivity92.1%Clinical Specificity98.1%Type of antigennucleoprotein1476COVID-19 Antigen Test Cassette659CITEST DIAGNOSTICS INCCanadawww.citestdiagnostics.com/YesCommercialisedNoNoNear POC / POCAntigenNasal swab no info in company website2021-05-10 13:04:001225Immuno-AntigenYesImmunoassayQualitative10Rapid diagnostic test LOD0AUCalibrationevaluatedCrossreactivityevaluatedFp4.4%Fn1.6%PrecisionevaluatedAccuracy97.2%(Antigen)ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity95.6%(Antigen)Type of antigennucleoprotein1455COVID-19 Antigen Test (Nasopharyngeal Swab)657Ulti Med Products GmbHGermanywww.ultimed.orgYesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swab2021-05-10 13:04:001205Immuno-AntigenYesNoImmunoassayQualitative15LOD100AUCalibrationNot evaluatedCrossreactivityevaluatedFp0.61%2 from 330Fn6.01%8 from 133PrecisionevaluatedAccuracy97.8%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity94%1238COVID-19 Antigen test631RDSM nvBelgiumwww.rdsm.eu/YesCommercialisedNoNoLateral flowNear POC / POCAntigenNasopharyngeal swabOropharyngeal swab https://www.rdsm.eu/covid19-Antigen-test.html2021-05-10 13:04:001021Immuno-AntigenYesNoImmunoassay15Clinical Sensitivity99.9%Clinical Specificity80.2%Clinical Specificity97.6%1378COVID-19 Antigen test657Ulti Med Products GmbHGermanywww.ultimed.orgYesCommercialisedNoNoN.A.Near POC / POCAntigenNasal swab2021-05-10 13:04:001143Immuno-AntigenYesNoImmunoassayQualitative15LOD100AUCrossreactivityEavaluatedFp1.23%Fn2.44%Accuracy98%Clinical Sensitivity96.4%Clinical Specificity99.2%1715COVID-19 Antigen Test762Redcell BiyoteknolojiTurkeyen.redcell.com.tr/YesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swab2021-05-10 13:04:001395Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD50000AUCalibrationnot evaluatedCrossreactivityevaluatedFp1.15%Out of 261 samples 3 of them were false positivesFn4.92%Out of 122 samples 6 of them were false negativesPrecisionevaluatedAccuracy99.2%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity95.08%Type of antigennucleoprotein1617COVID-19 Antigen Saliva Test Kit (Colloidal Gold)851Nantong Diagnos Biotechnology Co., LtdChinawww.diagnosbio.comYesCommercialisedNoNoCassetteNear POC / POCAntigenSaliva2021-05-10 13:18:201297Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD0.05AUCalibrationnot evaluatedCrossreactivityevaluatedFp0.67%Fn1.9%PrecisionevaluatedAccuracy98.82%(Antigen) ReproducibilityevaluatedRobustnessnot evaluatedClinical Sensitivity98.1%(Antigen) Type of antigennucleoprotein1579COVID-19 Antigen Saliva Test Kit455Assure Tech. (Hangzhou) Co., LtdChinawww.diareagent.com/YesCommercialisedNoNoAntigenSaliva2021-05-10 13:04:001258Immuno-AntigenYesNoImmunoassayQualitative15LOD0AUCalibrationevaluatedCrossreactivityevaluatedFpNot availableFnNot availablePrecisionevaluatedAccuracy95.3%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity90%1911COVID-19 Antigen Saliva Test Kit871Azure Biotech IncUnited Stateswww.azure.bioYesCommercialisedNoNoManualNear POC / POCAntigenSalivaNot available2021-05-10 13:04:001586Immuno-AntigenNoImmunoassayQualitativeColorimetry15LOD0AUCalibrationEvaluatedCrossreactivityEvaluatedPrecisionEvaluatedAccuracy95.3%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90%Clinical Specificity97%Type of antigenOther2037COVID-19 Antigen Saliva Test Kit938Assure Tech (Hangzhou) Co., LtdChinawww.diareagent.comYesCommercialisedNoNoLateral flowManualNear POC / POCAntigenSalivavariants_detected: B.1.258.21 B.1.117 C.2.12021-05-10 13:04:001715Immuno-AntigenNoImmunoassayQualitativeCaptureVisualisation system15The COVID-19 Antigen Saliva Test Kit detects SARS- CoV-2 viral antigens through visual interpretation of color development. Anti-SARS-CoV-2 antibodies are immobilized on the test region of the nitrocellulose membrane. Anti- SARS-CoV-2 antibodies conjugated to colored particles are immobilized on the conjugated pad. A sample is added to the extraction buffer, which is optimized to release the SARS-CoV-2 antigens from the specimen. During testing, target antigens, if present in the saliva samples, will be released into the extraction buffer individually packed in the kit. Consequently, the extracted antigens will bind to anti-SARS-CoV-2 antibodies conjugated to colored particles. As the specimen migrates along the strip by capillary action and interacts with reagents on the membrane, the complex will be captured by the anti-SARS-CoV-2 antibodies at the test region. Excess colored particles are captured at the internal control zone. The presence of a colored band in the test region indicates a positive result for the SARS-CoV-2 viral antigens, while its absence indicates a negative result. A colored band at the control region serves as a procedural control, generally indicating that the proper volume of specimen has been added and membrane wicking is working. This is a unique 1 step antigen test, which contains an RNA inactivating and antigen releasing buffer, in contrast to all other 1 step saliva essays. Making this the most sensitive essay of its kind. Please find more information, including parts of the technical file, through the wetransfer link shared above.LOD37AUCalibrationEvaluatedCrossreactivityEvaluatedFp0%none, 100% specificFn0%no false negatives occurred on antigen level at 1.48 mg/mL or virus level at 1×10 6.4TCID50/mL.PrecisionEvaluatedAccuracy93.9%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity86%Clinical Specificity100%(98.5%-100.0%)1641COVID-19 Antigen Saliva Test (Immunochromatography)657Ulti Med Products GmbHGermanywww.ultimed.orgYesCommercialisedNoNoCassetteLateral flowNear POC / POCAntigenSaliva2021-05-10 13:18:201321Immuno-AntigenNoImmunoassayQualitativeN.A.15rapid diagnostic test Lateral Flow LOD100AU100Calibrationnot evaluatedCrossreactivityevaluatedFp1.56%2 from 128Fn4.35%5 from 115PrecisionevaluatedAccuracy97%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity96%Type of antigennucleoprotein1598COVID-19 Antigen Rapid Test, Sienna873Canadawww.td-diagnostics.comYesCommercialisedNoNoNear POC / POCAntigen2021-05-10 13:04:001279Immuno-AntigenYesImmunoassay1937COVID-19 Antigen Rapid Test Kit(Swab)886Chongqing iSIA BIO-Technology Co., LtdChinawww.isiabio.com.cnYesCommercialisedNoNoLateral flowNear POC / POCAntigenthe sample is sending to the european country for testing2021-05-10 13:04:001613Immuno-Antigen15LOD0.9AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0%Fn0%PrecisionEvaluatedAccuracy98%ReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity97%Clinical Specificity100%Type of antigenOther1819COVID-19 Antigen Rapid Test Kit(Saliva)546Safecare Biotech (Hangzhou) Co. LtdChinaen.safecare.com.cn/YesCommercialisedNoNoLateral flowNear POC / POCAntigenSaliva2021-05-10 13:18:201497Immuno-AntigenYesNoImmunochromatographyQualitativeSandwichVisualisation system15LOD0.25AUCalibrationEvaluatedCrossreactivityEvaluatedFp0.55%Fn1.5%PrecisionEvaluatedAccuracy99.05%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.5%Clinical Specificity99.45%1489COVID-19 Antigen Rapid Test Kit (Swab)546Safecare Biotech (Hangzhou) Co. LtdChinaen.safecare.com.cn/YesCommercialisedYesYesNear POC / POCAntigenNasal swab2021-05-12 12:58:251234Immuno-AntigenYesNoImmunoassayQualitativeColorimetry10LOD0.5AUCalibrationNot EvaluatedCrossreactivityEvaluatedFp2.96%Fn0.56%PrecisionEvaluatedAccuracy98.41%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.04%Type of antigennucleoprotein1763COVID-19 Antigen Rapid Test Kit (Colloidal Gold)790Xiamen AmonMed Biotechnology Co., LtdChinawww.amonmed.comYesCommercialisedYesNoCassetteLateral flowNear POC / POCAntigenNasal swabThroat swab2021-05-10 19:40:141444Immuno-AntigenYesNoImmunochromatographyQualitativeColloidal gold15LOD170U/mlCalibrationNot evaluatedCrossreactivityEvaluatedFp0.45%Fn6.8%Accuracy97.52%ReproducibilityNot evaluatedRobustnessNot evaluatedClinical Sensitivity93.2%Clinical Specificity99.55Type of antigenNucleoprotein1899COVID-19 Antigen Rapid Test Kit (Colloidal Gold)867Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd.Chinaen.konsung.com/YesCommercialisedNoNoCardManualAntigenNasal swabNasopharyngeal swabOropharyngeal swabNone2021-05-10 13:04:001575Immuno-AntigenImmunochromatographyQualitativeColorimetryOther15LOD50AUCalibrationNot evaluatedCrossreactivityEvaluatedFp8AUFn5AUPrecisionEvaluatedAccuracy99.06%ReproducibilityNot evaluatedRobustnessNot evaluatedClinical Sensitivity97.14%Clinical Specificity99.34%Type of antigenNucleoprotein1996COVID-19 Antigen Rapid Test Kit (Colloidal Gold)916Xiamen Hopegen Medical Technology Co.,LtdChinaYesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swabNasopharyngeal swabThroat swabnone2021-05-10 13:04:001673Immuno-AntigenImmunoassayQualitativeColloidal gold20LOD170AUCalibrationEvaluatedCrossreactivityEvaluatedFp6.8%Fn0.45%PrecisionEvaluatedAccuracy97.52%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.2%Clinical Specificity99.55%Type of antigenNucleoprotein2066COVID-19 Antigen Rapid Test Kit (Colloidal Gold)954Jiangsu Konsung Bio-Medical Science And Technology Co.,Ltd.Chinahttps://en.konsung.com/YesCommercialisedNoNoCartridgeCassetteNear POC / POCAntigenAnterior nasal swabNasal swabNasopharyngeal swabOropharyngeal swab2021-05-17 10:50:591746Immuno-AntigenNoImmunochromatographyQualitativeMembrane-basedColloidal goldExtraction kit15LOD20AUCalibrationEvaluatedCrossreactivityEvaluatedFp4.57%Compared with RT-PCR: 8/175Fn0.41%Compared with RT-PCR: 5/1208PrecisionEvaluatedAccuracy99%(Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97%(Antigen)Clinical Specificity99%(Antigen)Type of antigenNucleoprotein1938COVID-19 Antigen Rapid Test Kit (Swab)886Chongqing iSIA BIO-Technology Co., LtdChinawww.isiabio.com.cnYesCommercialisedNoNoCassetteLateral flowNear POC / POCAntigennow sample in netherland for testing, result is good2021-05-10 13:04:001614Immuno-AntigenImmunoassayFluorescence15LOD0.9AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0%Fn0%PrecisionEvaluatedAccuracy99%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99%Clinical Specificity100%Type of antigenOther1310Covid-19 Antigen Rapid Test Kit35Beijing Beier Bioengineering Co., LtdChinawww.mediport.comYesCommercialisedNoNoManualNear POC / POCAntigenNasal swab2021-05-10 13:04:001080Immuno-AntigenYesImmunoassayQualitative15Rapid diagnostic test lateral flow Accuracy98.5%Clinical Sensitivity96.5%(95% CI: 93.7%~99.3%)Type of antigenNucleoprotein1081Immuno-AntigenYesYesImmunoassayQualitativeColorimetry15Manual NAT cassette colloidal gold LOD130AUFpRequire clinical data comparisonFnRequire clinical data comparisonAccuracy98.5%Clinical Sensitivity96.5%(95% CI: 93.7%~99.3%)Type of antigenNucleoprotein1363Covid-19 Antigen Rapid Test Kit413Hangzhou Clongene Biotech Co., LtdChinaen.clongene.com/YesCommercialisedYesYesCassetteNear POC / POCAntigenNasal swab2021-05-10 13:04:001122Immuno-AntigenYesNoImmunochromatographyQualitative15LOD2300AUFp0%Fn1.5%Accuracy99.6%Clinical Sensitivity98.5%Type of antigennucleoprotein1573COVID-19 Antigen Rapid Test Kit691Nantong Egens Biotechnology Co.,LtdChinawww.egens-bio.comYesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swab2021-05-10 13:04:001252Immuno-AntigenYesNoImmunoassayQualitativeColloidal gold15LOD38.5AUCalibrationevaluatedCrossreactivityevaluatedFp0.2%Fn4.2%PrecisionevaluatedAccuracy98.5%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity95.8%1995COVID-19 Antigen Rapid Test Kit915Shenzhen Dakewe Bio-engineering Co., Ltd.Chinawww.dakewe.comYesCommercialisedNoNoCassetteNear POC / POCAntigenAnterior nasal swabNasopharyngeal swabSaliva[Reagents and Materials Provided] COVID-19 Antigen Rapid Test (20 each) Foil pouched test device containing one test strip which is encased in plastic device cassette and one piece of desiccants. Extraction Buffer Vial (20 each) The extraction buffer vial contains 300μl extraction buffer solution. Collection Swab (20 each) Swabs for nasopharyngeal specimen collection (model CAR1) or swabs for anterior nares specimen collection (model CAR2). Collection Vial (20 each) Vial for the mix of swab specimen and extraction buffer. Preparation Plate (1 each) A 20-holes preparation plate, for fixing the collection vial. Package Insert (1 each) Instructions for use.2021-05-10 13:04:001671Immuno-AntigenImmunochromatographyQualitative15LOD22.5AUCalibrationNot evaluatedCrossreactivityEvaluatedFp2.17%(2/92)Fn0%(0/78)PrecisionEvaluatedAccuracy98.8%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity97.5%Clinical Specificity100%Type of antigenNucleoprotein2038COVID-19 Antigen Rapid Test Kit939Koch Biotechnology (Beijing) Co., LtdChinawww.kochbiotech.netYesCommercialisedNoNoStripNear POC / POCAntigenNasopharyngeal swabOropharyngeal swabThe KOCH Biotechnology COVID-19 Antigen Rapid Test Kit is an in-vitro diagnostic rapid test for the qualitative detection of SARS-CoV-2 antigen (Ag) in human nasopharyngeal- (Nasopharynx) or oropharyngeal- (throat) swab specimens from individuals who meet COVID-19 clinical and / or epidemiological criteria. The KOCH COVID-19 Antigen Rapid Test Kit is for professional use only and is intended to be used as an aid in the diagnosis of SARS-CoV-2 infection. The product may be used in any laboratory and non-laboratory environment that meets the requirements specified in the Instructions for Use and local regulation. The test provides preliminary test results. Negative results don’t preclude SARS-CoV-2 infection and they cannot be used as the sole basis for treatment or other management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information. The test is not intended to be used as a blood donor screening test for SARS-CoV-2. The KOCH Biotechnology COVID-19 Antigen Rapid Test Kit is based on colloidal gold immunochromatography to detect nucleocapsid (N) of the SARS-CoV-2 virus in respiratory secretions. When the specimen is added into the solution buffer inside the virus preservation tube and the test stripe has been added, the specimen is absorbed by the test stripe by capillary action, mixes with the gold-labelled antibody and flows across the pre-coated membrane. The antigen in the sample is captured by the gold-labelled antibody N1a and then bound to the antibody N1 immobilized in the test region (T) of the membrane. This creates a coloured line and indicates a positive test result. If there is no COVID-19 antigen in the specimen or the concentration is lower than the detection limit of the test, there is not a visible coloured line in the Test Region (T) of the device. This indicates a negative result. To serve as a procedure control, a coloured line will appear at the Control Region (C), if the test has been performed properly2021-05-10 13:04:001716Immuno-AntigenNoImmunochromatographyQualitative15LOD115CalibrationNot evaluatedCrossreactivityEvaluatedFp1%Fn0.7%PrecisionEvaluatedAccuracy99%(95%CI*: 98,30-99,70%)ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity98.5%(95%CI*: 97,20-99,80%)Clinical Specificity99.3%(95%CI*: 98,50-100%)Type of antigenNucleoprotein678COVID-19 Antigen Rapid Test Device; SARS-CoV-2 (N)protein Antigen rapid test (Fluorescence Immunochromatics assay)166LOMINA AGSwitzerlandwww.lomina.ch/YesCommercialisedNoNoCassetteNear POC / POCAntigenOropharyngeal swab2021-05-10 13:04:00807Immuno-AntigenYesYesImmunochromatographyQualitativeFluorescenceN.A.15LOD100ng/mLCalibrationEvaluatedAccuracy96.63%Clinical Sensitivity94.55%Clinical Specificity99.9%Type of antigenSARS-CoV-2 Nucleocapsid Protein Antigen263COVID-19 Antigen Rapid Test Device160Liming Bio-Products Co., LtdChinawww.limingbio.com/YesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swabOropharyngeal swab2021-05-10 13:04:00212Immuno-AntigenYesNoImmunoassayQualitative15LODEvaluatedCrossreactivityEvaluatedClinical Sensitivity93.1%Clinical Specificity100%681COVID-19 Antigen Rapid Test Device417Nanjing Liming BioProducts Co., LtdChinawww.limingbio.comNoNoNoCassetteNear POC / POCAntigenNasal swabSaliva2021-05-10 13:04:00809Immuno-AntigenYesNoImmunoassayQualitative15770COVID-19 Antigen Rapid Test Device455Assure Tech. (Hangzhou) Co., LtdChinawww.diareagent.com/YesCommercialisedNoNoCassetteManualNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swab2021-05-10 13:04:00623Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15Rapid diagnostic test LOD0CalibrationEvaluatedCrossreactivityEvaluatedFpNot availableFnNot availablePrecisionEvaluatedAccuracy99%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.7%Clinical Specificity99.1%1261COVID-19 Antigen Rapid Test Device635Chinawww.hgb.com.cn/YesCommercialisedNoNoNear POC / POCAntigenNasal aspirationThroat swab2021-05-10 13:04:001036Immuno-AntigenYesImmunoassay151906COVID-19 Antigen Rapid Test Device871Azure Biotech IncUnited Stateswww.azure.bioYesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabNot available2021-05-10 13:04:001672Immuno-AntigenImmunoassayAccuracy98.9%Clinical Sensitivity94.3%1682Immuno-AntigenNoImmunoassay15specimen = Nasal swabCalibrationEvaluatedCrossreactivityEvaluatedPrecisionEvaluatedAccuracy98.7%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95%Clinical Specificity99.2%Type of antigenOther1746COVID-19 Antigen Rapid Test Cassette(Saliva)413Hangzhou Clongene Biotech Co., LtdChinaen.clongene.com/YesCommercialisedNoNoCardCassetteLateral flowNear POC / POCAntigenSaliva2021-05-10 13:04:001424Immuno-AntigenYesNoImmunoassayQualitative15LOD3470U/mlCalibrationNot EvaluatedCrossreactivityEvaluatedFp3.2AUFn0.4AUPrecisionEvaluatedAccuracy99%ReproducibilityEvaluatedRobustnessNot EvaluatedClinical Sensitivity96.8%Type of antigenNucleoprotein1878COVID-19 Antigen Rapid Test Cassette(Oral Fluid)128Hangzhou Biotest Biotech Co., LtdChinaen.biotests.com.cnYesCommercialisedNoNoCassetteLateral flowNear POC / POCAntigenSalivaA rapid test for the qualitative detection of COVID-19 antigen in oral fluid.2021-05-10 13:18:201558Immuno-AntigenNoImmunoassayQualitative10LOD0CalibrationEvaluatedCrossreactivityEvaluatedFp0%324 negative samples are confirmed by RT-PCR and tested, no false positive result is observed.Fn5%2 false negative results are observed in 40 positive samples confirmed by RT-PCRPrecisionEvaluatedAccuracy99.5%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95%Clinical Specificity100%Type of antigenNucleoprotein1827COVID-19 Antigen Rapid Test Cassette (Swab)833Zhengzhou Fortune Bioscience Co., LtdChinawww.fortunetest.comYesCommercialisedNoNoCassetteLateral flowManualNear POC / POCAntigenNasal swabNasopharyngeal swabWe are a professional supplier of in vitro diagnostic products in Henan Province, China. We have experienced in vitro diagnostic personnel and professional team to meet the different needs of customers. For the COVID-19 rapid test product we have series of antibody, antigen and nucleic acid test, and all have obtained CE certification. With a purification workshop of 6000 square meters and a daily output of 300000 people, it can provide customers with one-stop service of COVID-19 Rapid Test.2021-05-10 13:04:001504Immuno-AntigenNoImmunochromatographyQualitativeSandwichExtraction kit20LOD0.01AUCalibrationEvaluatedCrossreactivityEvaluatedFpNoneFn3.64%PrecisionEvaluatedAccuracy98.1%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.36%Clinical Specificity100%1890COVID-19 Antigen Rapid Test Cassette (Saliva/Nasopharyngeal Swab)128Hangzhou Biotest Biotech Co., LtdChinaen.biotests.com.cnYesCommercialisedNoNoCassetteLateral flowNear POC / POCAntigenNasopharyngeal swabSalivaA rapid test for the qualitative detection of COVID-19 antigen in Saliva and Nasopharyngeal Swab2021-05-10 13:18:201568Immuno-AntigenNoImmunoassayQualitative10LOD0AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0%No false positive result is observed in 324 negative samples confirmed by RT-PCRFn7.3%19 false negative results are observed in 260 positive samples confirmed by RT-PCRPrecisionEvaluatedAccuracy96.7%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.7%Clinical Specificity100%Type of antigenNucleoprotein1991COVID-19 Antigen Rapid Test Cassette (Oral Fluid)912Biozek MedicalNetherlandswww.biozek.comYesCommercialisedNoNoLateral flowManualAntigenSalivaSputumPlease contact for more information: Robyn White Robyn.white@medusa19.com Data Summary With Additional Information Below: LOD: 100 TCID50/mL COVID-19 Variants: This test has been tested on the UK/South Africa and Kent Strain - all variants are detectable using this device. Sensitivity: 91.67%（95%CI*:85.90%~95.62%） Specificity: 99.72%（95%CI*:98.44%~＞99.99%） Accuracy: 97.39%（95%CI*:94.94%~98.87%）2021-05-10 13:04:001667Immuno-AntigenNoImmunoassayQuantitative15This test has been tested on the UK/South Africa and Kent StrainLOD100AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0.28%(1/354)Fn8.33%(12/144)PrecisionNot evaluatedAccuracy97.39%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity91.67%Clinical Specificity99.72%Type of antigenNucleoprotein1868COVID-19 Antigen Rapid Test Cassette (Nasopharyngeal Swab)128Hangzhou Biotest Biotech Co., LtdChinaen.biotests.com.cnYesCommercialisedNoNoCassetteNear POC / POCAntigenNasopharyngeal swab2021-05-10 13:18:201545Immuno-AntigenYesImmunoassayQualitative10LOD0AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0.83%3/363Fn5%2/40PrecisionEvaluatedAccuracy98.8%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95%Clinical Specificity99.2%Type of antigenNucleoprotein1876COVID-19 Antigen Rapid Test Cassette (Nasal Swab)128Hangzhou Biotest Biotech Co., LtdChinaen.biotests.com.cnYesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swabA rapid test for the qualitative detection of COVID-19 antigen in Nasal Swab.2021-05-10 13:18:201920COVID-19 Antigen Rapid Test Cassette (Colloidal Gold)877Jiangsu Diagnostics Biotechnology Co.,Ltd.Chinadiagnostics-bio.comYesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabThroat swabURL of instruction manual： https://maiimg.com/pdf/?e=agJOCeRyb8CMIm2021-05-10 13:04:001596Immuno-AntigenNoImmunoassayQualitativeCaptureSample preparation15LOD2338AUCalibrationEvaluatedCrossreactivityEvaluatedFp10AUThere were 10 false positive casesFn0%There was no false negativePrecisionEvaluatedAccuracy98.39%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.58%Clinical Specificity100%Type of antigenNucleoprotein1837COVID-19 Antigen Rapid Test Cassette (Colloidal Gold Method)840Wuhan NanoDiagnosis for Health Biotechnology Co., LtdChinandh-biotech.comYesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabSalivaLOD is 5x10ˆ2.55TCID50/ml Our rapid test reliably detects the known SARS-CoV-2 mutations VOC-202012/01 (or B.1.1.7, N501Y.V1, or UK variant) and N501Y.V2 (or B.1.351 or South African variant).2021-05-10 13:18:201515Immuno-AntigenNoImmunoassayQualitativeColorimetryValidity test kit10LOD3581.5AUCalibrationNot evaluatedCrossreactivityEvaluatedFp1.9%2 false positives in 105 testsFn0.6%2 false negatives in 331 testsPrecisionEvaluatedAccuracy99.08%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity98.1%Clinical Specificity99.4%Type of antigenNucleoprotein1610COVID-19 Antigen Rapid Test Cassette413Hangzhou Clongene Biotech Co., LtdChinaen.clongene.com/YesCommercialisedNoNoCassetteLateral flowNear POC / POCAntigenNasopharyngeal swab2021-05-10 13:18:201290Immuno-AntigenYesNoImmunoassayQualitativeN.A.15LOD2338TCID50/mlFp0%0 of 64Fn2.71%6 of 221Clinical Sensitivity91.4%Clinical Specificity100%Type of antigennucleocapside protein1467Covid-19 Antigen Rapid Test Cassette682Swedicine ABSwedenwww.swedicine.comYesCommercialisedNoNoCassetteLateral flowNear POC / POCAntigenNasal swab2021-05-10 13:04:001218Immuno-AntigenYesNoImmunoassayQualitative15LOD5.07AUCalibrationevaluatedCrossreactivityevaluatedPrecisionevaluatedAccuracy98%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity96.4%Type of antigennucleoprotein1451COVID-19 Antigen Rapid Test (Vstrip)676AnTaimmu BioMedTaiwan ROCwww.antaimmu.comYesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swab2021-05-10 13:04:001203Immuno-AntigenYesNoImmunoassayQualitativeColorimetry10LOD1.571035AUCalibrationevaluatedCrossreactivityevaluatedFp92.31%Positive predictive value: % (95%CI: 62.97%- 98.83%) Fn96.49%Negative predictive value: 96.49% (95%CI: 88.40%-99.00%) PrecisionevaluatedAccuracy95.71%CI95%:: 87.98%-99.11%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity85.71%CI95%: 57.19%- 98.22%Type of antigennucleoprotein1947COVID-19 Antigen Rapid Test (Oral Fluid)126Hangzhou AllTest Biotech Co., LtdChinawww.alltests.com.cn/YesCommercialisedNoNoCassetteLateral flowNear POC / POCAntigenSalivaThe COVID-19 Antigen Rapid Test (Oral Fluid) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in oral fluid specimens from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2 nucleocapsid protein antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.2021-05-10 13:18:201623Immuno-AntigenImmunochromatographyQualitative15LOD100AUCalibrationEvaluatedCrossreactivityEvaluatedFp0.007AUFn0.0099AUPrecisionEvaluatedAccuracy97%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90.1%Clinical Specificity99.3%Type of antigenNucleoprotein1949COVID-19 Antigen Rapid Test (Oral Fluid)890Acro Biotech IncUnited Stateswww.acrobiotech.comYesCommercialisedNoNoCassetteLateral flowNear POC / POCAntigenSalivaThe COVID-19 Antigen Rapid Test (Oral Fluid) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in oral fluid specimens from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2 nucleocapsid protein antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.2021-05-10 13:04:001625Immuno-AntigenImmunochromatographyQualitative15LOD100AUCalibrationEvaluatedCrossreactivityEvaluatedFp0.007AUFn0.097AUPrecisionEvaluatedAccuracy96.8%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90.3%Clinical Specificity99.3%Type of antigenNucleoprotein1205COVID-19 Antigen Rapid Test (Latex)44Joinstar Biomedical Technology Co., LtdChinawww.joinstar.cnYesCommercialisedNoNoLateral flowNear POC / POCAntigenOtherSaliva2021-05-10 13:04:00990Immuno-AntigenYesNoImmunoassayQualitative15Fp0%Compared to PCR (n=60) no FP in each of saliva, and sputum.sputum, samplesFn13.33%Compared to PCR (n=60) 5 false negatives in saliva and 3 in sputum1480COVID-19 Antigen Rapid Test (For Reader)659CITEST DIAGNOSTICS INCCanadawww.citestdiagnostics.com/YesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swab2021-05-10 13:04:001229Immuno-AntigenYesYesImmunoassayQualitative15LOD0AUCalibrationevaluatedCrossreactivityevaluatedFp0.08%Fn3.6%PrecisionevaluatedAccuracy98%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity96.4%Type of antigennucleoprotein1702COVID-19 Antigen Rapid Test (For Reader)890Acro Biotech IncUnited Stateswww.acrobiotech.comYesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swab2021-05-10 13:18:201382Immuno-AntigenYesYesImmunoassayQualitative15LOD0AUCalibrationevaluatedCrossreactivityevaluatedFp2.3AUFn1AUPrecisionevaluatedAccuracy98.6%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity97.7%Type of antigennucleoprotein1446COVID-19 Antigen Rapid Test (Colloidal Gold Method)533Hangzhou Singclean Medical Products Co., LtdChinawww.singclean.net/YesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swabSaliva2021-05-10 13:04:001196Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD4AUCalibrationevaluatedCrossreactivityevaluatedFp1.44%98.56Fn0.97%99.03PrecisionevaluatedAccuracy98.84%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity98.56%Type of antigennucleoprotein1257COVID-19 Antigen Rapid Test126Hangzhou AllTest Biotech Co., LtdChinawww.alltests.com.cn/YesCommercialisedNoNoCassetteNear POC / POCAntigenNasopharyngeal swab2021-05-10 13:04:001033Immuno-AntigenYesImmunoassayQualitative151792COVID-19 Antigen Rapid Test503DIAsource ImmunoAssaysBelgiumwww.diasource-diagnostics.com/YesCommercialisedNoNoCardNear POC / POCAntigenNasal swabThis test is recommended by the belgian autohorities (FAMHP)2021-05-10 13:18:201198COVID-19 Antigen Rapid Test624Zhejiang Anji Saianfu Biotech Co., LtdChinawww.seinofy.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabOtherSaliva http://www.reopentest.com/ifu2021-05-10 13:04:00984Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD7200AU/mLAccuracy91%Clinical Sensitivity90%Clinical Specificity98%1387COVID-19 Antigen Rapid Test659CITEST DIAGNOSTICS INCCanadawww.citestdiagnostics.com/YesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swab2021-05-10 13:04:001153Immuno-AntigenYesNoImmunoassayQualitative15LOD0AUCalibrationNot evaluatedFp0.08%Fn3.6%Accuracy98%Clinical Sensitivity96.4%1596COVID-19 Antigen Rapid Test705Chinawww.lhbiotech.com.cn/YesCommercialisedNoNoNear POC / POCAntigen2021-05-10 13:04:001277Immuno-AntigenYesImmunoassayQualitative1797COVID-19 Antigen Rapid Test808PRIMA LabSwitzerlandprimahometest.com/en/YesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swabOther2021-05-10 13:04:001476Immuno-AntigenYesNoImmunochromatographyQualitative15The test can be used both with nasopharyngeal and nasal swab. Functionality confirmed with the most known SARS-CoV-2 Variants including English, Brazilian and South African.LOD100IU/mlFp0Fn0Accuracy98%Clinical Sensitivity96.4%1688COVID-19 Antigen Rapid Test890Acro Biotech IncUnited Stateswww.acrobiotech.comYesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swabOther2021-05-10 13:18:201367Immuno-AntigenYesNoImmunoassayQualitative15LOD0Calibrationnot evaluatedCrossreactivityevaluatedFp1AUFn2.3AUPrecisionevaluatedAccuracy98.6%(Antigen)ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity97.7%(Antigen)1997COVID-19 Antigen Rapid Test917Beijing North Institute of Biotechnology CO., LtdChinaYesCommercialisedNoNoCassetteLateral flowNear POC / POCAntigenNasal swabThroat swabnone2021-05-10 13:04:001674Immuno-AntigenImmunoassayQualitative20LOD100AUCalibrationEvaluatedCrossreactivityEvaluatedFp5.3%Fn1%PrecisionEvaluatedAccuracy97.4%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.7%Clinical Specificity99%Type of antigenNucleoprotein2036COVID-19 Antigen Rapid Test937BioMaxima SAPolandwww.biomaxima.comYesCommercialisedNoNoCassetteManualNear POC / POCAntigenNasopharyngeal swabCat. No. 1-364-K020, the COVID-19 Antigen Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 antigens in nasopharyngeal swab specimens from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests.2021-05-10 13:04:001714Immuno-AntigenNoImmunochromatographyQualitativeCapture15LOD100AUCalibrationNot evaluatedCrossreactivityEvaluatedFp1AUFn3AUPrecisionEvaluatedAccuracy98%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96%Clinical Specificity99%Type of antigenNucleoprotein1280COVID-19 Antigen ELISA561AMS UK (NI) LtdUnited Kingdomwww.amslabs.co.ukYesCommercialisedNoNoAutomatedManualAntigen2021-05-10 13:04:001055Immuno-AntigenNoYesELISASandwich1894COVID-19 Antigen Detection Test461Meril Diagnostics Pvt LtdIndiawww.merillife.com/medical-devices/diagnosticsYesCommercialisedNoNoLateral flowAutomatedManualAntigenNasopharyngeal swabCOVID-19 Antigen Detection Test is a rapid immunochromatographic assay kit for the qualitative detection of SARS-CoV-2 antigen in nasopharyngeal swab from human. For professional use.2021-05-10 13:18:201571Immuno-AntigenNoImmunochromatographyQualitativeExtraction kit20LOD250AUCalibrationEvaluatedCrossreactivityEvaluatedFp0%Fn0%PrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.6%Clinical Specificity100%Type of antigenOther1187COVID-19 Antigen Detection Kit (Immunofluorescence Assay)619Zhuhai Lituo Biotechnology Co., LtdChinawww.lituo.com.cnYesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swab http://www.lituo.com.cn/en/showpro.php?id=3272021-05-10 13:04:00971Immuno-AntigenYesYesImmunoassayQualitativeFluorescence15Type of antigennucleoprotein1957COVID-19 Antigen Detection Kit (Colloidal Gold)619Zhuhai Lituo Biotechnology Co., LtdChinawww.lituo.com.cnYesCommercialisedNoNoLateral flowManualNear POC / POCAntigenNasal swabNasopharyngeal swabOropharyngeal swabSalivaWe've been marketed in Protugal, Hungary, Poland, Slovenia, Slovakia, Czech, etc.2021-05-10 13:18:201633Immuno-AntigenYesNoImmunochromatographyQualitativeSandwich, DoubleColloidal goldValidity test kit10The microbial interference and endogenous interference study are also evaluated. LOD428AUCalibrationEvaluatedCrossreactivityEvaluatedFp0.53%with 190 sample, there is 1 false positiveFn3%with 233 sample, there is 7 false negativePrecisionEvaluatedAccuracy98.04%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.86%Clinical Specificity99.47%Type of antigenNucleoprotein1501COVID-19 Antigen Detection Kit690New Gene (Hangzhou) Bioengineering Co., LtdChinawww.new-gene.net/YesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swab2021-05-10 13:04:001251Immuno-AntigenYesNoChromatography30LOD0.05AUCalibrationnot evaluatedCrossreactivityevaluatedFp2%Fn0.9%PrecisionevaluatedAccuracy98.3%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity98%Type of antigennucleocapside1258COVID-19 and Influenza A+B Antigen Combo Rapid Test with Reader126Hangzhou AllTest Biotech Co., LtdChinawww.alltests.com.cn/YesCommercialisedNoNoNear POC / POCAntigen2021-05-10 13:04:001034Immuno-AntigenYesImmunoassay1471COVID-19 and Influenza A+B Antigen Combo Rapid Test Cassette659CITEST DIAGNOSTICS INCCanadawww.citestdiagnostics.com/YesCommercialisedNoNoNear POC / POCAntigenNasal swab no info in company website2021-05-10 13:04:001220Immuno-AntigenYesNoImmunoassayQualitative15Rapid diagnostic test lateral flow LOD0AUCalibrationNot evaluatedCrossreactivityevaluatedFp0.08%(0.9% Influenza A); (0.9% Influenza B)Fn3.6%(5.0% Influenza A); (7.1% Influenza B)PrecisionevaluatedAccuracy98%(98.4 Influenza A); (98.1 Influenza B)ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity96.4%(95.0 Influenza A); (92.9 Influenza B)1391COVID-19 and Influenza A+B Antigen Combo Rapid Test (Nasopharyngeal Swab)657Ulti Med Products GmbHGermanywww.ultimed.orgYesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swab2021-05-10 13:04:001157Immuno-AntigenYesNoImmunoassayQualitative15LOD100AUFp0.82%Fn3.61%Accuracy98%Clinical Sensitivity96.4%Clinical Specificity99.2%1256COVID-19 and Influenza A+B Antigen Combo Rapid Test126Hangzhou AllTest Biotech Co., LtdChinawww.alltests.com.cn/YesCommercialisedYesNoNear POC / POCAntigen2021-05-10 19:40:141032Immuno-AntigenYesImmunoassay1360COVID-19 Ag Test Kit655Guangdong Wesail Biotech Co., LtdChinaen.wesailbio.comYesCommercialisedYesNoLateral flowNear POC / POCAntigenNasal swab2021-05-10 13:04:001132Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD552AUFp4/500Fn5/500Accuracy98.4%Clinical Sensitivity90%Clinical Specificity98%Type of antigennucleoprotein1689Covid-19 Ag Test 758TurklabTurkeywww.turklab.com.tr/YesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swabOther2021-05-10 13:18:201368Immuno-AntigenYesNoImmunoassayQualitative20LOD30AU133COVID-19 Ag Respi-Strip73Coris BioConceptBelgiumwww.corisbio.com/YesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swab2021-05-10 13:04:0092Immuno-AntigenYesNoImmunoassayQualitativeColorimetry30LOD5000TCID50/mlLOD0.25ng/mLCalibrationNot ReportedCrossreactivityCross-reactivity: no cross-reactivity for bacteria and virus tested including seasonal Coronaviruses (HKU1, 229E, OC43, NL63), positive for SARS-CoVAccuracy97.9%Clinical Sensitivity91.2%Clinical Specificity99.4%1216COVID-19 Ag Rapid Test Kit (Immuno-Chromatography)569Guangdong Longsee Biomedical Co., LtdChinawww.longseemed.comYesCommercialisedNoNoNear POC / POCAntigenSaliva2021-05-10 13:04:001001Immuno-AntigenYesImmunochromatographyQualitativeColorimetryRapid diagnostic test Colloidal Gold 2049COVID-19 Ag Rapid Test Cassette944MedicalSystem Biotechnology Co. Ltd.Chinahttps://en.nbmedicalsystem.com/en/NoCommercialisedNoNoCassetteLatexNear POC / POCAntigenNasopharyngeal swabOropharyngeal swabSalivaThroat swabN.A.2021-05-10 13:04:001727Immuno-AntigenNoImmunochromatographyQualitativeOther15LOD150AUCalibrationEvaluatedCrossreactivityEvaluatedFp1.33%Fn7.33%PrecisionEvaluatedAccuracy90%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.67%Clinical Specificity98.67%Type of antigenNucleoprotein1614COVID-19 Ag Rapid Test718Celltrion DiaTrustSouth Koreawww.celltrion.comNoCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swab2021-05-10 13:04:001294Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15Rapid diagnostic test colloidal gold Fp100%(82/82) (95% CI: 95.5%-100.0%)Fn97%(161/166) (95% CI: 93.1%-98.7%)Clinical Sensitivity94.3%(82/87) (95% CI: 87.2%-97.5%)Clinical Specificity100%(161/161) (95% CI: 97.7%-100.0%)Type of antigennucleocapside protein1877128Hangzhou Biotest Biotech Co., LtdChinaen.biotests.com.cnYesCommercialisedNoNoCassetteLateral flowNear POC / POCAntigenNasopharyngeal swab2021-05-10 13:18:201557Immuno-AntigenNoImmunoassayQualitative10LOD0AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0.83%3 false positive results are observed in 363 negative samples confirmed by RT-PCRFn5%2 false negative results are observed in 40 positive samples confirmed by RT-PCRPrecisionEvaluatedAccuracy98.8%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95%Clinical Specificity99.2%Type of antigenNucleoprotein1891128Hangzhou Biotest Biotech Co., LtdChinaen.biotests.com.cnYesCommercialisedNoNoCassetteLateral flowNear POC / POCAntigenNasopharyngeal swab2021-05-10 13:18:201569Immuno-AntigenNoImmunoassayQualitative10LOD0AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0%No false positive result is observed in 324 negative samples confirmed by RT-PCRFn%2 false negative results are observed in 40 positive samples confirmed by RT-PCRPrecisionEvaluatedAccuracy99.5%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95%Clinical Specificity99%(＞99.9)Type of antigenNucleoprotein1892128Hangzhou Biotest Biotech Co., LtdChinaen.biotests.com.cnYesCommercialisedNoNoCassetteLateral flowNear POC / POCAntigenNasopharyngeal swab2021-05-10 13:18:201570Immuno-AntigenNoImmunoassayQualitative10LOD0AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0%No false positive result is observed in 324 negative samples confirmed by RT-PCRFn5%2 false negative results are observed in 40 positive samples confirmed by RT-PCRPrecisionEvaluatedAccuracy99.5%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95%Clinical Specificity99.9%(＞99.9)1736COVID-19 (SARS-CoV-2) Antigen Test Kit(Colloidal Gold)24Anhui Deep Blue Medical Technology Co., LtdChinawww.dbluemedical.com/YesCommercialisedYesNoNear POC / POCAntigenNasal swabOther2021-05-10 19:40:141415Immuno-AntigenYesNoImmunoassayQualitativeColorimetry20rapid diagnostic test cassette colloidal gold LOD320Calibrationnot evaluatedCrossreactivityevaluatedFp2.27%5 of 220Fn0.9%2 of 220PrecisionevaluatedAccuracy98ReproducibilityevaluatedRobustnessnot evaluatedClinical Sensitivity95.7Type of antigennucleoprotein1815COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold) - Nasal Swab24Anhui Deep Blue Medical Technology Co., LtdChinawww.dbluemedical.com/YesCommercialisedYesNoLateral flowNear POC / POCAntigenAnterior nasal swabNasal swabPlease check attached UK national systematic evaluation report with the detailed data from UK government validation, performed by University of Oxford. Public Health England Porton Down. 132 brands were tested and only 4 suppliers have passed all of the Phase 3B validation, including ANHUI DEEPBLUE MEDICAL. The link of this report: https://www.medrxiv.org/content/10.1101/2021.01.13.21249563v1.full-text Please check attached UK national systematic evaluation report with the detailed data from UK government validation, performed by University of Oxford. Public Health England Porton Down. 132 brands were tested and only 4 suppliers have passed all of the Phase 3B validation, including ANHUI DEEPBLUE MEDICAL. The link of this report: https://www.medrxiv.org/content/10.1101/2021.01.13.21249563v1.full-text And we have attached the MHRA registration certificate. Also the registration in Germany, registration in Italy, registration in Portugal and so on.2021-05-12 12:27:461493Immuno-AntigenYesNoImmunochromatographyQualitativeColorimetry20LOD320AUCalibrationEvaluatedCrossreactivityEvaluatedFp0.2%Fn3.6%PrecisionEvaluatedAccuracy99.03%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.4%Clinical Specificity99.8%Type of antigenNucleoprotein1589COVID-19 (Sars-CoV-2) Antigen Test Kit (Colloidal Gold)24Anhui Deep Blue Medical Technology Co., LtdChinawww.dbluemedical.com/YesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swabSaliva website not accessible (considered suspicious for the EC) 2021-05-10 13:18:201269Immuno-AntigenYesNoImmunoassayQualitativeColorimetry20Rapid diagnostic test cassette LOD320AUCalibrationevaluatedCrossreactivityevaluatedFp0Fn3.6PrecisionevaluatedAccuracy99.03%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity96.4%Type of antigennucleoprotein1830COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold)834BN SantéFrancewww.callmedicall.com/YesIn developmentNoNoManualAntigenNasal swabSalivaNo additional information2021-05-10 13:04:001506Immuno-AntigenImmunoassayColloidal gold20LOD320AUCalibrationEvaluatedCrossreactivityEvaluatedFp3Fn1PrecisionEvaluatedAccuracy99.22%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.1%Clinical Specificity99.8%Type of antigenNucleoprotein1372455Assure Tech. (Hangzhou) Co., LtdChinawww.diareagent.com/YesCommercialisedNoNoNear POC / POCAntigenOther immunochromatography?2021-05-10 13:04:001146Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15Rapid diagnostic test colloidal gold LOD0AUAccuracy87.8%(COVID-19:87.8%; M. pneumoniae:96.6%)Clinical Sensitivity75.8%(COVID-19:75.8%, M. pneumoniae:91.4%)1373455Assure Tech. (Hangzhou) Co., LtdChinawww.diareagent.com/YesCommercialisedNoNoNear POC / POCAntigenOther this kit needs to be checked, in the name states nucleic acid but it is submitted as immuno-antigen2021-05-10 13:04:001137Immuno-AntigenNoNoImmunoassayQualitative120LOD500AUType of antigennucleoprotein1371455Assure Tech. (Hangzhou) Co., LtdChinawww.diareagent.com/YesCommercialisedNoNoNear POC / POCAntigenOther immunochromatography?2021-05-10 13:04:001144Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15Rapid diagnostic test colloidal gold FpNot availableFnNot availableAccuracy98.5%(COVID-19:98.5%, Influenza A:88.4%, Influenza B:88.9%)Clinical Sensitivity97.3%(COVID-19:97.3%, Influenza A:83.3%, Influenza B:82.4%)1354851Nantong Diagnos Biotechnology Co., LtdChinawww.diagnosbio.comYesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swabNasopharyngeal swabThroat swab2021-05-10 13:18:201128Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15Accuracy: 97.60% Influenza. Clinical sensitivity 96.67% InfluenzaLOD0.05%Accuracy96%Clinical Sensitivity92.59%Type of antigennucleoprotein1618COVID - 19 Antigen Test Kit721Artron Laboratories IncCanadawww.artronlab.comYesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swabNasopharyngeal swab2021-05-10 13:04:001298Immuno-AntigenYesNoImmunoassayQualitative15Rapid diagnostic test cassette CrossreactivityEvaluatedFpEvaluatedFnEvaluatedPrecisionEvaluatedAccuracy98.16%RobustnessEvaluatedClinical Sensitivity91.27%CI95%: 84.92% - 95.56%Clinical Specificity100%CI95%: 99.22% - 100%Type of antigennucleoproteinType of antigenNucleoprotein1913COVDIAG SALIVA681TODA PHARMAFrancehttps://www.todapharma.com/YesNoNoCassetteLateral flowNear POC / POCAntigenSalivaSputumPlease kindly note that the above mentioned performance rates were assessed on saliva specimens.2021-05-10 13:04:001590Immuno-AntigenNoImmunochromatographyQualitativeColorimetry10LOD125AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0.42%On 236 negative samples confirmed by RT-PCR, 235 were also negative with our test : 1 false positiveFn7.1%On 169 positive samples confirmed by RT-PCR,157 were also positive with our test: 12 false negativesPrecisionEvaluatedAccuracy96%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92%Clinical Specificity99%Type of antigenNucleoprotein1313CovBELD647EMBIO Diagnostics LTDCypruswww.embiodiagnostics.euYesCommercialisedNoNoNear POC / POCAntigenNasal swabSaliva2021-05-10 13:04:001083Immuno-AntigenYesYesImmunoassayQualitative3LOD4000U/mlCalibrationEvaluatedCrossreactivityNot EvaluatedFp2.2%3 on 136Fn7.27%8 of 110PrecisionEvaluatedAccuracy95.52%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.73%Type of antigennucleoprotein1834COV-QUANTO837AAZ-LMBFrancewww.covid19aaz.comYesCommercialisedNoNoMicroplateSemi-automatedAntigenPlasmaSerumNA2021-05-10 13:04:001513Immuno-AntigenYesELISAQuantitativeSandwich, Double210LOD2.97AUCalibrationNot evaluatedCrossreactivityEvaluatedFp1.6%Fn7%PrecisionEvaluatedAccuracy85%CI: range: 85-115 (Antigen)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93%Clinical Specificity98.4%1196CoV-Check DIRECT Covid-19 Antigen Test623Spark Diagnostics LLCIndiawww.sparkdiagnostics.comYesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swab2021-05-10 13:04:00981Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD380AUFp0.9%Fn8.6%Accuracy95.7%Clinical Sensitivity93.1%1343Coronavirus Ag Rapid Test Cassette (Swab)760Zhezhiang Orient Gene Biotech Co., LtdChinawww.orientgene.com/YesCommercialisedYesYesCassetteLateral flowManualNear POC / POCAntigenNasal swabNasopharyngeal swab2021-05-10 13:18:201124Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD115AUCalibrationNot evaluatedCrossreactivityEvaluatedFp2.5%2/120Fn0.27%2/745PrecisionEvaluatedAccuracy99.42%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.32%Clinical Specificity99.6%Type of antigennucleoprotein1831Coronavirus Ag Rapid Test Cassette (Swab)836Van Oostveen Medical B.V.Netherlandswww.romed.nl/enYesCommercialisedNoNoCassetteManualNear POC / POCAntigenNasal swabNasopharyngeal swab2021-05-10 13:04:001509Immuno-AntigenNoImmunochromatographyQualitativeColorimetryN.A.15LOD115AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0.34%3 false positives / 874 true negative (sum of nasopharyngeal and nasal swab samples)Fn2.19%5 false negatives / 228 true positive (sum of nasopharyngeal and nasal swab samples)PrecisionEvaluatedAccuracy99.42%99.42 (antigen-nasopharyngeal), 98.73 (antigen-nasal)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.32%98.32 (antigen-nasopharyngeal), 97.25 (antigen-nasal)Clinical Specificity99.6%99.60 (antigen-nasopharyngeal), 100 (antigen-nasal)Type of antigenNucleoprotein2031Coronavirus Ag Rapid Test Cassette (Swab)934Bio-Rad Laboratories / Zhejiang Orient Gene BiotechChinawww.bio-rad.comYesCommercialisedNoNoCassetteLateral flowManualNear POC / POCAntigenNasal swabNasopharyngeal swabProduct reference: 12015553 Packaging : 20 tests / box Storage : 2-30°C Total shelf life: 24 months2021-05-10 13:04:001709Immuno-AntigenNoImmunoassayQualitativeMembrane-based15LOD115AUCalibrationEvaluatedCrossreactivityEvaluatedFp0.4%Nasopharyngeal Swab: 3/743 , Nasal Swab: 0/128Fn1.71%Nasopharyngeal Swab: 2/117 , Nasal Swab: 3/106PrecisionEvaluatedAccuracy99%Nasopharyngeal Swab: 99,42% / Nasal Swab: 98,73%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98%Nasopharyngeal Swab: 98,32% / Nasal Swab: 97,25%Clinical Specificity99%Nasopharyngeal Swab: 99,6% / Nasal Swab: 100%Type of antigenNucleoprotein1767Coronavirus Ag Rapid Test Cassette554Healgen ScientificUnited Stateswww.healgen.comYesCommercialisedYesYesCassetteNear POC / POCAntigenNasopharyngeal swab2021-05-10 13:18:201446Immuno-AntigenYesNoImmunochromatographyQualitative15Clinical Sensitivity80.6%C.I. 95, range: 72.7-86.6Clinical Specificity99.7%C.I. 95, range: 98.9-99.976Coronavirus (SARS-Cov-2) N protein Detection Kit (Fluorescence immunochromatography)414Beijing Savant Biotechnology Co., LtdChinawww.huaketai.com/YesCommercialisedNoNoCassetteAutomatedManualAntigenThroat swab2021-05-10 13:04:00569Immuno-AntigenYesYesImmunochromatographyQualitativeFluorescence15LOD50ng/mLCrossreactivityEvaluated1935Coronavirus (SARS-CoV 2) Antigen - Swab Specimen885Tody Laboratories Int.Romaniawww.todylaboratories.com/YesCommercialisedNoNoCassetteManualAntigenNasal swabNasopharyngeal swab99.9% Accuracy: 96.2% False positives (nasal swab specimen): From studies performed by manufacturer, the false positive rate is <0.1% (specificity = >99.9%) False negatives (nasal swab specimen): From studies performed by manufacturer, the false negative rate is 7.1% (sensitivity = 92.9%)]]>2021-05-10 13:04:001611Immuno-AntigenNoImmunochromatographyQualitativeMembrane-basedN.A.15LOD100AUCalibrationEvaluatedCrossreactivityEvaluatedFp1%From studies performed by manufacturer, the false positive rate is 1.0% (specificity = 99.0%)Fn3.6%From studies performed by manufacturer, the false negative rate is 3.6% (sensitivity = 96.4%)PrecisionEvaluatedAccuracy98.2%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.4%Clinical Specificity99%Type of antigenNucleocapsid (N) protein1934Coronavirus (SARS-CoV 2) Antigen - Oral Fluid885Tody Laboratories Int.Romaniawww.todylaboratories.com/YesCommercialisedNoNoCassetteManualAntigenDeep (cough) sputumSalivaSputumMinimum detection limit = 100 pg/ml2021-05-10 13:04:001610Immuno-AntigenNoImmunochromatographyQualitativeMembrane-based15LOD100AUCalibrationEvaluatedCrossreactivityEvaluatedFpFrom studies performed by manufacturer, the false positive rate is 0.7% (specificity = 99.3%)FnFrom studies performed by manufacturer, the false negative rate is 9.9% (sensitivity = 90.1%)PrecisionEvaluatedAccuracy97%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90.1%Clinical Specificity99.3%Type of antigenNucleoprotein1662CORONA-Ag529DyonMed SAGreecedyonmedical.com/en/home/YesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swabOtherSaliva2021-05-10 13:04:001341Immuno-AntigenYesNoImmunoassayQualitative15LOD0AUCalibrationevaluatedCrossreactivityevaluatedFp0%Compared to PCR (n=60) no FP in each of saliva, and sputum.sputum, samplesFn8.3%Compared to PCR (n=60) 5 false negatives in saliva and 3 in sputumPrecisionevaluatedAccuracy97%AntigenReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity95%AntigenType of antigennucleoprotein1929Corona Virus (COVID-19) Antigen Rapid Test (Colloidal Gold883Hoyotek Biomedical Co.,LtdChinahoyotek.cn/index.htmlYesCommercialisedNoNoCardNear POC / POCAntigenNasopharyngeal swabOropharyngeal swabSalivaThe product is based on the principle of sandwich and colloidal gold immunochromatography, the nitrocellulose membrane Test Zone is pre-coated with mouse anti-Corona Virus (COVID-19) monoclonal antibody, the Control Zone is pre-coated with goat anti-mouse polyclonal antibody, the gold conjugation pad is pre-coated with colloidal gold labeled mouse anti-Corona Virus (COVID-19) monoclonal antibody. When testing positive samples, COVID-19 Antigen the sample will be combined with colloidal gold (Au) labeled mouse anti-Corona Virus (COVID-19) monoclonal antibody and form into immune complexes (Au-mouse anti-Corona Virus (COVID-19) monoclonal antibody-[COVID-19- (Antigen)]), the complexes will move forward inside the nitrocellulose membrane by chromatography effect. When reaching Test Zone, the complexes will be combined with mouse anti-Corona Virus (COVID-19) monoclonal antibody, and form into “(Au-mouse anti-Corona Virus (COVID-19) monoclonal antibody-[COVID-19- (Antigen)])-[ mouse anti-Corona Virus (COVID-19) monoclonal antibody]”, thus agglutination color appears; The residual colloidal gold labeled mouse anti-Corona Virus (COVID-19) monoclonal antibody will be combined with goat anti-mouse polyclonal antibody at the Control Zone, and produce color under agglutination. When testing negative samples, there’s no COVID-19 Antigen in the samples, no immune complexes will be formed and color only appears in the Control line.2021-05-10 13:04:001605Immuno-AntigenNoImmunochromatographyQualitativeSandwichColloidal goldOther15LOD10AUCalibrationEvaluatedCrossreactivityEvaluatedFp1%[1%(Nasopharyngeal swab/Antigen);2.5%(Oropharyngea swab/Antigen);2.7%(Saliva/Antigen)]Fn4%[4%(Nasopharyngeal swab/Antigen);7%(Oropharyngea swab/Antigen);9%(Saliva/Antigen)]PrecisionEvaluatedAccuracy98.4%[98.4%(Nasopharyngeal swab/Antigen);94.8%(Oropharyngea swab/Antigen);96.6%(Saliva/Antigen)]ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96%[96%(Nasopharyngeal swab);93%(Oropharyngea);91%(Saliva)]Clinical Specificity99%[99%(Nasopharyngeal swab/Antigen);97.5%(Oropharyngea swab/Antigen);97.3%(Saliva/Antigen)]Type of antigenOther1810CORMAY RAPID SARS-CoV-2 ANTIGEN TEST KIT579CORMAYPolandcormay.pl/index.php?lang=_enYesCommercialisedNoNoCassetteManualAntigenNasopharyngeal swabOropharyngeal swabFully functional kit contains: cassettes, swabs, extraction buffers, extraction tubes, nozzles with filters and clear IFU.2021-05-10 13:04:001489Immuno-AntigenYesNoImmunochromatographyQualitativeCapture15LOD1.25AUCalibrationEvaluatedCrossreactivityEvaluatedFp-Fn-PrecisionEvaluatedAccuracy96%ReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity95%Clinical Specificity98%1919Coretests COVID-19 Ag Test420Core Technology Co., LtdChinawww.coretests.comYesCommercialisedYesYesCassetteNear POC / POCAntigenNasopharyngeal swabCOVID-19 Ag Test is the chromatographic immunoassay test used for qualitative detection of the COVID-19 antigen in human nasopharyngeal swab specimens. This test kit uses COVID-19 monoclonal antibody and goat anti-mouse IgG polyclonal antibodies that are respectively immobilized on a nitrocellulose membrane. It uses colloidal gold to label sufficient COVID-19 monoclonal antibody. Using nano-colloidal gold technology and applying highly specific antibody-antigen reaction and immunochromatographic analysis technology principle. When testing, the novel coronavirus antigen in the sample combined with the colloidal gold-labeled COVID-19 monoclonal antibody to form a complex, which was then combined with the COVID-19 monoclonal antibody coated in the T line during chromatography, at this time there is one red line in the T area .When the samples do not contain novel coronavirus antigen, colloidal gold-labeled COVID-19 monoclonal antibody cannot combined with COVID-19 monoclonal antibody in the T line region, so there is no red colored line in the T area .Regardless of the presence of novel coronavirus antigen in the sample, a red line will form in the quality control area (C). The red line appears in the quality control area (C) serves as: 1.verification that sufficient volume is added. 2.that proper flow is obtained 3. and as a control for the reagents.2021-05-10 20:12:511595Immuno-AntigenYesNoImmunoassayQualitativeSandwich15LOD22.5AUCalibrationEvaluatedCrossreactivityEvaluatedFp0.4%Fn1.9%PrecisionEvaluatedAccuracy99.2%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.1%Clinical Specificity99.6%Type of antigenNucleoprotein1781CORA-CHECK-19-comfort777fameditec GmbHGermanywww.fameditec.deYesCommercialisedNoNoCassetteNear POC / POCAntigenSaliva2021-05-10 13:04:001460Immuno-AntigenYesNoImmunochromatographyQualitativeColorimetry15LOD1.25U/mlCalibrationEvaluatedCrossreactivityEvaluatedFp169AUFn236AUAccuracy96.79%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.9%1744CORA CHECK-19777fameditec GmbHGermanywww.fameditec.deYesCommercialisedNoNoCassetteNear POC / POCAntigenNasal swab2021-05-10 13:04:001422Immuno-AntigenYesNoImmunochromatographyQualitativeColorimetry15LOD1.25U/mlCalibrationEvaluatedFp209AUFn450AUPrecisionEvaluatedAccuracy98.79%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.17%267CLIP-COVID19 (smartphone-read out high sensivity antigen detection test)163Luminostics, IncUnited Statesluminostics.com/NoIn developmentNoNoNear POC / POCAntigen2021-05-10 13:04:00216Immuno-AntigenYesImmunoassay1218CLINITEST Rapid Covid-19 Antigen Test444Siemens HealthineersGermanywww.siemens-healthineers.comYesCommercialisedYesYesCassetteNear POC / POCAntigenNasal swabNasopharyngeal swab2021-05-10 13:04:001002Immuno-AntigenYesNoImmunochromatographyQualitative15Fp0.23%2 out of 865Fn0%0Accuracy98.74%Clinical Sensitivity97.25%Nasal SwabClinical Sensitivity98.32%Nasopharyngeal swabClinical Specificity100%Nasal SwabType of antigenS1, S1-RBD, S2, N proteins1691CHIL COVID-19 Antigen Rapid Test (Nasopharyngeal / Oropharyngeal Swab-Casette)589CHIL Medical Supplies LtdTurkeywww.chil.com.tr/YesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swab2021-05-10 13:04:001370Immuno-AntigenYesNoImmunoassayQualitativeSandwich20LOD30%CalibrationevaluatedCrossreactivityevaluatedFp0.99%( 4 False Positives out of 405)Fn0.43%(2 False Negatives out of 466)PrecisionevaluatedAccuracy99.54%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity99.01%Type of antigennucleoprotein1173CerTest SARS-CoV-2 Card test737CerTest BiotecSpainwww.certest.esYesCommercialisedYesYesCassetteNear POC / POCAntigenNasopharyngeal swab2021-05-10 13:18:20957Immuno-AntigenYesNoImmunoassayQualitativeMagnetic Electrochemical10LOD1000TCID50/mlLOD1ng/mLCrossreactivity0AUClinical Sensitivity92.9%Clinical Specificity99.6%1249CerTest SARS-CoV-2737CerTest BiotecSpainwww.certest.esYesCommercialisedNoNoCardAutomatedManualAntigenNasopharyngeal swab2021-05-10 13:18:201027Immuno-AntigenImmunoassayQualitative10Clinical Sensitivity92.9%Clinical Specificity99.6%Type of antigennucleoprotein1199CAT610Oncosem Onkolojik Sistemler San. ve Tic. A.S.Turkeywww.oncosem.comYesCommercialisedYesNoLateral flowNear POC / POCAntigenNasal swab https://oncosem.com/cat/2021-05-10 19:40:13985Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD0.01AUFp6.25%out of 32 confirmed positive people 2 of them were diagnosed as negative 30 of them succesfulFn1.96%out of 204 confirmed negative people 4 of them were diagnesed as positive 200 of them succesfulAccuracy97.46%Clinical Sensitivity93.75%Clinical Specificity98.04%1987Biozek covid-19 Antigen Rapidtest BCOV-802910Inzek International tradingNetherlandswww.inzek.nl/YesCommercialisedNoNoCassetteLateral flowManualAntigenSalivaCheck IFU for more information. Clinical studies available. Biozek Sales organisation Mach-E BV the Netherlands2021-05-10 13:04:001663Immuno-AntigenNoImmunochromatographyQualitative10LOD100AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0.28%(1 / 354)Fn8.33%(12 / 144)PrecisionEvaluatedAccuracy97%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity91%Clinical Specificity99%Type of antigennucleocapsid protein 1988Biozek covid-19 Antigen Rapidtest BCOV-502910Inzek International tradingNetherlandswww.inzek.nl/YesCommercialisedNoNoCassetteLateral flowManualAntigenNasal swabNasopharyngeal swabFor more information Check IFU. Sales organisation Mach-E BV The Netherlands2021-05-10 13:04:001664Immuno-AntigenNoImmunochromatographyQualitative10LOD100AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0.34(2 / 589)Fn5%(5 / 100)PrecisionEvaluatedAccuracy98.98%ReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity95%Clinical Specificity99.66%Type of antigennucleocapsid protein 2013biotical SARS-CoV-2 Ag Card925Biotical Health S.L.U.Spainhttps://biotical.es/es/YesCommercialisedNoNoLateral flowManualNear POC / POCAntigenNasopharyngeal swabLOD: 1000 TCID50/ml LOD: 1 ng/mL2021-05-10 13:04:001691Immuno-AntigenNoImmunochromatographyQualitative10LOD1000AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0%Fn3%PrecisionEvaluatedAccuracy99%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96%Clinical Specificity99%Type of antigenNucleoprotein1494BIOSYNEX COVID-19 Ag+ BSS651BIOSYNEX S.A.Francewww.biosynex.comYesCommercialisedNoNoNear POC / POCAntigenOther2021-05-10 13:18:201244Immuno-AntigenYesNoImmunoassayQualitative10Rapid diagnostic test lateral flow LOD750AUCalibrationnot evaluatedCrossreactivityevaluatedFp0%Clinical data: 0 false positive result out of 583 negative samples confirmed by RT-PCRFn2.53%Clinical data: 2 false negative results out of 79 positive samples confirmed by RT-PCRPrecisionevaluatedAccuracy99.7%(95%CI: 98.9-100%)ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity97.5%(95%CI: 91.1-99.7%)Type of antigennucleoprotein1223BIOSYNEX COVID-19 Ag BSS651BIOSYNEX S.A.Francewww.biosynex.comYesCommercialisedYesYesCassetteNear POC / POCAntigenOther2021-05-10 13:18:201007Immuno-AntigenYesNoImmunochromatographyQualitativeColorimetry15Type of antigennucleocapsid protein 1599Biomerica COVID-19 Antigen Rapid Test (nasopharyngeal swab)708Biomerica, Inc.United Statesbiomerica.com/index.aspYesCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swab data available upon request 2021-05-10 13:04:001280Immuno-AntigenYesNoImmunoassayQualitative15Rapid diagnostic test lateral flow LOD0.0001AUCalibrationevaluatedCrossreactivityevaluatedFp1AUFn8AUPrecisionevaluatedAccuracy98%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity94.7%Type of antigennucleoprotein689Bioeasy 2019-Novel Coronavirus (2019-nCoV) Ag GICA Rapid Test393Shenzhen Bioeasy Biotechnology Co., LtdChinaen.bioeasy.com.tr/YesCommercialisedNoNoCassetteNear POC / POCAntigenWhole blood2021-05-10 13:04:00541Immuno-AntigenYesNoImmunoassayQualitativeColorimetry10365Bioeasy 2019-nCoV Ag Fluorescence Rapid Test Kit (Time-Resolved Fluorescence)393Shenzhen Bioeasy Biotechnology Co., LtdChinaen.bioeasy.com.tr/YesCommercialisedNoNoCassetteNear POC / POCAntigenDeep (cough) sputumNasal swabSaliva2021-05-10 13:04:00681Immuno-AntigenYesYesImmunoassayQualitativeFluorescenceSample preparation101963BIOCREDIT COVID-19 Ag Test Nasal220RapiGEN IncSouth Korearapigen-inc.comYesCommercialisedNoNoCassetteLateral flowManualNear POC / POCAntigenNasal swabAs optional content, external controls swabs can be provided as a means on additional quality control to demonstrate a positive or negative reaction.2021-05-10 13:18:201639Immuno-AntigenNoImmunochromatographyQualitativeMembrane-based10LOD267AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0.95%2/211 (RT PCR)Fn6.94%5/72 (RT PCR)PrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93%Clinical Specificity99%Type of antigenNucleoprotein1606BIOCREDIT COVID-19 Ag - SARS-CoV 2 Antigen test220RapiGEN IncSouth Korearapigen-inc.comYesCommercialisedYesYesNear POC / POCAntigenNasopharyngeal swab2021-05-10 20:07:301287Immuno-AntigenYesNoImmunoassayQualitative10Clinical Sensitivity90.2%Clinical Specificity100%1962BIOCREDIT COVID-19 Ag220RapiGEN IncSouth Korearapigen-inc.comYesCommercialisedNoNoCassetteLateral flowManualNear POC / POCAntigenNasopharyngeal swabAs optional content, external controls swabs can be provided as a means on additional quality control to demonstrate a positive or negative reaction.2021-05-10 13:18:201638Immuno-AntigenNoImmunochromatographyQualitativeMembrane-based10LOD562AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0.95%1st study-Korea:0/100 (RT PCR); 2nd study-Italy: 2/211 (RT PCR)Fn6.94%1st study-Korea:7/92 (RT PCR); 2nd study-Italy: 5/72 (RT PCR)PrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93%1st study-Korea: 90,2 (Antigen); 2nd study-Italy: 93,05(Antigen)Clinical Specificity100%1st study-Korea: 100 (Antigen); 2nd study-Italy: 100 (Antigen)Type of antigenNucleoprotein335BIOCREDIT COVID-19 Ag480BioVendorCzechiawww.biovendor.com/YesCommercialisedNoNoCassetteNear POC / POCAntigenNasopharyngeal swab2021-05-10 13:04:00665Immuno-AntigenYesNoImmunoassayQualitativeColorimetry8Clinical Sensitivity90.2%Clinical Specificity100%1687biocomma®COVID-19 Antigen Test Kit757Biocomma limitedChinawww.biocomma.comYesCommercialisedNoNoNear POC / POCAntigenNasal swab2021-05-10 13:04:001366Immuno-AntigenYesYesChromatographyQualitative15LOD312.5AUCalibrationEvaluatedCrossreactivityEvaluatedFp0.55%Fn17.9%PrecisionEvaluatedAccuracy97.13%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity82.14%Type of antigennucleoprotein2015Atellica IM SARS-CoV-2 Antigen (CoV2Ag)444Siemens HealthineersGermanywww.siemens-healthineers.comYesCommercialisedNoNoOtherLab-basedAntigenNasopharyngeal swab2021-05-10 13:04:001693Immuno-AntigenNoImmunoassayQualitativeSandwichChemiluminescence26LOD18.2TCID50/mlCalibrationEvaluatedCrossreactivityEvaluatedPrecisionEvaluatedReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity97.55%(CI: 94.37–99.20%)Clinical Specificity100%(CI:99.03%–100%)1761Asan Easy Test Flu/COVID-19 Ag Combo741Asan Pharmaceutical CO., LTDSouth Koreawww.asanpharm.comYesCommercialisedNoNoCassetteManualAntigenNasal swab2021-05-10 13:04:001440Immuno-AntigenYesNoImmunochromatographyQualitativeColorimetry15LOD1230U/mlCalibrationNot evaluatedCrossreactivityEvaluatedReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity94.7%Clinical Specificity97.4%1654Asan Easy Test COVID-19 Ag741Asan Pharmaceutical CO., LTDSouth Koreawww.asanpharm.comYesCommercialisedYesNoCassetteLateral flowNear POC / POCAntigenNasal swab2021-05-10 19:40:141733Immuno-AntigenYesImmunoassay1926ARISTA COVID-19 Antigen Rapid Test879ARISTA Biotech Pte. LtdSingaporewww.aristabio.comYesCommercialisedNoNoLateral flowStripNear POC / POCAntigenAnterior nasal swabDeep (cough) sputumMid-turbinates swabNasal swabNasopharyngeal swabOropharyngeal swabSputumARISTA COVID-19 Antigen Rapid Test can detect the B. 1. 1. 7 SARS-CoV-2 variants.2021-05-10 13:04:001602Immuno-AntigenNoImmunochromatographyQualitativeMembrane-basedOther15LOD100AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0.81AUFn9.56AUPrecisionEvaluatedAccuracy96.4%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90.44%Clinical Specificity99.71%Type of antigenNucleoprotein1853Aria COVID-19 Ag Rapid Test79CTK Biotech, IncUnited Stateswww.ctkbiotech.com/YesCommercialisedNoNoCassetteLateral flowManualNear POC / POCAntigenNasal swabNasopharyngeal swabStudy has shown that the CTK Aria COVID-19 Ag Rapid Test can detect both the Sars-Cov-2 UK variant and South Africa variant. The test is registered Australia, Brazil, EU and 20 other additional countries.2021-05-10 13:18:201533Immuno-AntigenNoImmunochromatographyQualitativeColorimetry15LOD280AUCalibrationEvaluatedCrossreactivityEvaluatedFp0%Fn7.7%PrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity92.3%Clinical Specificity100%Type of antigenNucleoprotein1594Antigen Rapid Test COVID-19 Coretests420Core Technology Co., LtdChinawww.coretests.comYesCommercialisedNoNoNear POC / POCAntigenNasopharyngeal swab2021-05-10 13:04:001274Immuno-AntigenYesNoImmunoassayQualitative151608ANTIGEN RAPID TEST CASSETTE SARS-COV-2 (SWAB)713A. Menarini DiagnosticsItalywww.menarinidiagnostics.comYesCommercialisedNoNoCassetteNear POC / POCAntigenNasopharyngeal swab2021-05-10 13:04:001288Immuno-AntigenYesNoImmunoassayQualitative15Accuracy98.74%95%CI: 96.80%-99.66%Clinical Sensitivity96.72%95%CI: 88.65%-99.60%Clinical Specificity99.22%95%CI: 97.21%-99.91%Type of antigennucleocapside protein1592Antigen Rapid Test Ag SARS-CoV-2703Lifotronic Technology Co, LtdChinaen.lifotronic.com/YesCommercialisedNoNoNear POC / POCAntigen2021-05-10 13:04:001272Immuno-AntigenYesImmunoassayQualitative10Clinical Sensitivity91%Clinical Specificity98%1843AndLucky SARS-CoV-2 Antigen SPUTUM Rapid Test Kit (non-invasive)624Zhejiang Anji Saianfu Biotech Co., LtdChinawww.seinofy.comYesCommercialisedNoNoManualAntigenOropharyngeal swabSputumThroat secretionThroat swabBfArM Listed, PEI Evaluated2021-05-10 13:18:201520Immuno-AntigenNoImmunochromatographyQualitative10LOD6AUCalibrationEvaluatedCrossreactivityEvaluatedFp6.5%93,5Fn0.6%99,40PrecisionEvaluatedAccuracy97%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93%Clinical Specificity99%Type of antigenNucleoprotein1842AndLucky SARS-CoV-2 Antigen Anterior Nasal Rapid Test (minimal invasive)624Zhejiang Anji Saianfu Biotech Co., LtdChinawww.seinofy.comYesCommercialisedNoNoNear POC / POCAntigenNasal swabNasopharyngeal swabBfArm Listed, PEI-Evaluated2021-05-10 13:18:201519Immuno-AntigenNoImmunochromatographyQualitative10LOD6AUCalibrationEvaluatedCrossreactivityEvaluatedFp2.5%97,5Fn1%99PrecisionEvaluatedAccuracy98%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97%Clinical Specificity99%2008AndLucky SARS CoV-2 Antigen Rapid Test, Anterior Nasal Check (minimal-invasiv)624Zhejiang Anji Saianfu Biotech Co., LtdChinawww.seinofy.comNoCommercialisedNoNoLateral flowAutomatedNear POC / POCAntigenAnterior nasal swabNasal swabThe detection limit of the coronavirus antigen rapid test is 5.75x10^2TCID50/m2021-05-10 13:18:201686Immuno-AntigenNoImmunoassayQualitative15LOD5.75AUCalibrationEvaluatedCrossreactivityEvaluatedFp2AUFn4AUPrecisionEvaluatedAccuracy98.47%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.52%Clinical Specificity99.13%Type of antigenNucleoprotein1296AndLucky COVID-19 Antigen Rapid Test624Zhejiang Anji Saianfu Biotech Co., LtdChinawww.seinofy.comYesCommercialisedYesNoCassetteNear POC / POCAntigenNasal swabSaliva2021-05-10 19:40:141102Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD5.75AUFp95.8AUFn99AUAccuracy97.9%AntigenClinical Sensitivity95.8%AntigenType of antigennucleoprotein1304AMP Rapid Test SARS-CoV-2 Ag531AMEDA Labordiagnostik GmbHAustriawww.amp-med.com/YesCommercialisedYesYesCassetteNear POC / POCAntigenNasal swab2021-05-10 13:04:001076Immuno-AntigenYesImmunochromatographyQualitative15CrossreactivityEvaluatedPrecisionEvaluatedAccuracy98.8%ReproducibilityEvaluatedRobustnessEvaluatedRobustnessEvaluatedClinical Sensitivity97.3%Type of antigenNucleoproteinType of antigenNucleoprotein829Amela Covid-19 Antigen test478Amedica SANetherlandswww.amedicagroup.com/YesCommercialisedNoNoAutomatedManualAntigen2021-05-10 13:04:00680Immuno-AntigenImmunoassay1647AllCheck COVID19 Ag738CALTH Inc.South Koreawww.thecalth.comYesCommercialisedNoNoCartridgeNear POC / POCAntigenNasopharyngeal swab2021-05-10 13:04:001328Immuno-AntigenYesNoImmunoassayQualitative10LOD250TCID50/mlPositive control40AUNegative control60AUAnalytical Sensitivity97.5%Analitical Specificity100%Clinical Sensitivity97.12%Clinical Specificity93.98%Throughputsingle cartridges1449AFIAS COVID-19/Flu Ag Combo22Boditech Med IncSouth Koreawww.boditech.co.kr/eng/YesCommercialisedNoNoAutomatedManualAntigenNasal swab2021-05-10 13:04:001199Immuno-AntigenYesImmunoassayQualitativeFluorescence20LOD56AUCalibrationEvaluatedCrossreactivityEvaluatedPrecisionEvaluatedAccuracy99.3%ReproducibilityEvaluatedRobustnessNot EvaluatedClinical Sensitivity96.8%Type of antigennucleoprotein1248AFIAS COVID-19, Viral Antigen (automated)22Boditech Med IncSouth Koreawww.boditech.co.kr/eng/YesCommercialisedNoNoAutomatedManualAntigenNasopharyngeal swab2021-05-10 13:04:001026Immuno-AntigenYesImmunoassayQualitativeFluorescence15Clinical Sensitivity87.5%Clinical Specificity96.5%105AFIAS COVID-19, Viral Antigen22Boditech Med IncSouth Koreawww.boditech.co.kr/eng/YesCommercialisedNoNoCartridgeAutomatedAntigen2021-05-10 13:04:0026Immuno-AntigenImmunoassaySemiquantitativeFluorescence1989AFIAS COVID-19 Ag22Boditech Med IncSouth Koreawww.boditech.co.kr/eng/YesCommercialisedNoNoCartridgeNear POC / POCAntigenNasopharyngeal swabCountries that have completed practical validation studies https://lci.rivm.nl/antigeensneltesten2021-05-10 13:18:201665Immuno-AntigenYesImmunoassayQualitativeMembrane-basedOther12LOD35.15AUCalibrationEvaluatedCrossreactivityEvaluatedFpRequire clinical data comparisonFnRequire clinical data comparisonPrecisionEvaluatedAccuracy95.5%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity91.7%Clinical Specificity98.7%Type of antigenNucleoprotein663Adx SARS Cp V-2 Virus Antigen Rapid Point of Care Test404Aptamer Group LtdUnited Kingdomwww.aptamergroup.comNoIn developmentNoNoNear POC / POCAntigen2021-05-10 13:04:00556Immuno-AntigenYesImmunoassay2016ADVIA Centaur XP/XPT SARS-CoV-2 Antigen (CoV2Ag)444Siemens HealthineersGermanywww.siemens-healthineers.comYesCommercialisedNoNoOtherLab-basedAntigenNasopharyngeal swabphysical support: Magnetic particles2021-05-10 13:04:001694Immuno-AntigenNoImmunoassayQualitativeSandwichChemiluminescence28LOD20.8TCID50/mlCalibrationEvaluatedCrossreactivityEvaluatedPrecisionEvaluatedReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity97.46%(CI:94.18–99.17%)Clinical Specificity99.62%(CI:97.92–99.99%)Type of antigenNucleoprotein1243ActivXpress+ COVID-19 Antigen Complete Testing Kit88Edinburgh Genetics LimitedUnited Kingdomeggenetics.com/YesCommercialisedNoNoCassetteNear POC / POCAntigenNasopharyngeal swabOropharyngeal swab2021-05-10 13:04:001024Immuno-AntigenYesNoImmunochromatographyQualitative15LOD35ng/mLClinical Sensitivity94.7%Clinical Specificity100%1981Absoludy COVID-19 Ag Rapid909Absology Co., Ltd.South Koreawww.absology.co.krYesCommercialisedNoNoCardLateral flowManualNear POC / POCAntigenNasopharyngeal swabOropharyngeal swabAbsoludy COVID-19 Ag Rapid is based on immunochromatography for the qualitative determination of SARS-CoV-2 virus specific antigens in human Nasopharyngeal and Oropharyngeal swab specimen. The monoclonal antibodies against SARS-CoV-2 virus are immobilized onto a membrane as capture antibodies in the Test region (T). When the nasopharynx swab specimens resuspended in extraction buffer solution are added to the sample well, the specimen starts to react with the gold-conjugate that SARS-CoV-2 virus specific antibodies were bound on colloidal gold. The mixture moves along the membrane by capillary action and reacts with fixed SARS-CoV-2 virus antibodies in the Test region (T). When SARS-CoV-2 virus is present in a sample, different intensity of red band appears on Test region of the membrane depending on the amount of SARS-CoV-2 virus present in the sample. The colorless of band in the Test region (T) indicates a negative result.2021-05-10 13:04:001657Immuno-AntigenYesNoImmunochromatographyQualitativeCapture15LOD125AUCalibrationEvaluatedCrossreactivityEvaluatedFp0%Fn0%PrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%Clinical Specificity100%Type of antigenNucleoprotein1982Absoludy COVID-19 Ag909Absology Co., Ltd.South Koreawww.absology.co.krYesCommercialisedNoNoCartridgeLateral flowNear POC / POCSemi-automatedAntigenNasopharyngeal swabOropharyngeal swabAbsoludy COVID-19 Ag for use in conjunction with ABSOL instrument, is an in vitro diagnostic medical device based on lateral flow fluorescent immunoassay (FIA.) Reagent buffer in pretreatment tubes contains the ingredients that help to block and inhibit interference/cross reactions with extra substances, and to stabilize and catalyze target antigen-antibody reactions for improved performance. After patient specimen is mixed with pretreatment reagent, the mixture is loaded onto the inlet hole of the Absoludy COVID-19 Ag. The mixtures migrate via capillary action along the cartridge, (Nucleocapsid protein (NP)) from the patient specimen first bind to the (Fluorescent conjugated Anti-COVID-19 antibody) located on the detection region of the Absoludy COVID-19 Ag. Then, upon migrating towards the test region, these complexes, [(SARS-CoV-2 NP Antigen)-(Anti-COVID-19 antibody)], secondly bind to the immobilized (AntiCOVID-19 antibody) on the test regions. The amount of (Anti-COVID-19 antibody) binding to the (SARS-CoV-2 antigens) on the test regions indicate the concentrations of (SARS-CoV-2 NP Antigen) present in the patient specimen. The cartridge with specimen mixture is then scanned/read by the ABSOL instrument, allowing the cartridge to complete the incubation and reaction. The reaction takes around 5 minutes from loading of specimen to the display of results on the ABSOL instrument. Intensities of the fluorescence is converted into electric signals which correlate to the intensities of fluorescence generated at the respective test regions and hence to the concentrations of respective (SARS-CoV-2 NP Antigen) from the patient specimen. ABSOL instrument computes respective (SARS-CoV-2 NP Antigen) concentrations, and ultimately displays the results of the Absoludy COVID-19 Ag qualitatively as ‘Negative’ or ‘Positive’ along with cut-off index (COI) values based on pre-programed analytical concentrations.2021-05-10 13:04:001658Immuno-AntigenYesImmunoassaySemiquantitativeFluorescence5MicrofluidicLOD1.25AUCalibrationEvaluatedCrossreactivityEvaluatedFp1.08%(1/92)Fn2%(1/50)PrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98%Clinical Specificity99%Type of antigenNucleoprotein18092019-nCoV/IAV/IBV Antigen Test Kit (colloidal gold method)779Guangdong Hecin Scientific, Inc.Chinawww.hecin-scientific.cn/YesCommercialisedNoNoCassetteNear POC / POCAntigen2021-05-10 13:04:001487Immuno-AntigenYesImmunoassayQualitativeColorimetry15LOD1AUCalibrationEvaluatedCrossreactivityEvaluatedFp2AUFn2AUPrecisionEvaluatedAccuracy98.51%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.23%Clinical Specificity99.07%Type of antigennucleoprotein17472019-nCoV Antigen Test Kit (colloidal gold method)779Guangdong Hecin Scientific, Inc.Chinawww.hecin-scientific.cn/YesCommercialisedYesNoCardNear POC / POCAntigenNasopharyngeal swab2021-05-10 19:40:141425Immuno-AntigenYesNoImmunoassayQualitativeColorimetry15LOD175TCID50/mlCrossreactivityEvaluatedFp2AUFn2AUPrecisionEvaluatedAccuracy98.51%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.23%Type of antigenNucleoprotein16742019-nCoV Antigen Test Kit750Chinawww.MDfastcheck.comYesCommercialisedNoNoCassetteLab-basedAntigenNasal swab2021-05-10 13:04:001353Immuno-AntigenYesYesImmunoassayQualitativeColorimetry15LOD0.05AUCalibrationEvaluatedCrossreactivityEvaluatedPrecisionEvaluatedAccuracy99.26%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.83%Type of antigenNucleoprotein17902019-nCoV Antigen Rapid Test Kit (Colloidal Gold Immunochromatography)319Beijing Lepu Medical Technology Co., LtdChinaen.lepumedical.com/YesCommercialisedNoNoCardOtherAntigenNasal swabOther2021-05-10 13:04:001469Immuno-AntigenYesNoImmunochromatographyQualitativeColorimetry15LOD200IU/mlCalibrationNot evaluatedCrossreactivityEvaluatedFp0.38%Fn4.94%PrecisionEvaluatedPrecisionEvaluatedAccuracy97.44%ReproducibilityEvaluatedRobustnessNot EvaluatedClinical Sensitivity95.06%Type of antigenNucleoprotein12832019-nCoV Antigen Rapid Test Kit (colloidal gold assay)38Beijing Diagreat Biotechnologies Co., LtdChinawww.diagreat.com/YesCommercialisedNoNoNear POC / POCAntigenNasal swab2021-05-10 13:04:001093Immuno-AntigenYesImmunoassayQualitativeColorimetry15Type of antigenN protein12732019-nCoV Antigen Rapid Test (Colloidal Gold)262Sure Bio-Tech (USA) Co., LtdUnited Stateswww.surebiotech.com/YesCommercialisedNoNoNear POC / POCAntigenNasal swabThroat swab2021-05-10 13:04:001047Immuno-AntigenYesImmunoassayQualitativeColorimetry15Clinical Sensitivity92.5%Clinical Specificity99.16%12032019-nCoV Antigen Device561AMS UK (NI) LtdUnited Kingdomwww.amslabs.co.ukYesCommercialisedNoNoNear POC / POCAntigenNasal swabSaliva2021-05-10 13:04:00989Immuno-AntigenYesNoImmunochromatographyQualitative15Rapid diagnostic test Lateral flow Fp0.9%Fn9.1%Accuracy97.5%Clinical Sensitivity90.9%12022019-nCoV Antigen Device575Prestige DiagnosticsUnited Kingdomwww.prestigediagnostics.co.ukYesCommercialisedNoNoLateral flowNear POC / POCAntigenNasal swabSaliva2021-05-10 13:04:00988Immuno-AntigenYesNoImmunoassayQualitative15Fp0.9%Fn9.1%Accuracy97.5%Clinical Sensitivity90.9%17042019-nCoV Antigen Control (IFA)379SHENZHEN YHLO BIOTECH CO., LtdChinawww.szyhlo.comYesCommercialisedNoNoAutomatedManualAntigen2021-05-10 13:04:001384Immuno-AntigenYesImmunoassayOther15LOD0AUCalibrationnot evaluatedCrossreactivitynot evaluatedPrecisionevaluatedReproducibilityevaluatedRobustnessevaluated17032019-nCoV Antigen Control (CLIA)379SHENZHEN YHLO BIOTECH CO., LtdChinawww.szyhlo.comYesCommercialisedNoNoAutomatedManualAntigen2021-05-10 13:04:001383Immuno-AntigenYesImmunoassayChemiluminescenceLOD0AUCalibrationNot evaluatedCrossreactivityNot EvaluatedPrecisionEvaluatedAccuracy100%AntigenReproducibilityEvaluatedRobustnessEvaluated17052019-nCoV Antigen Control (CGIA)379SHENZHEN YHLO BIOTECH CO., LtdChinawww.szyhlo.comYesCommercialisedNoNoAutomatedManualAntigenOther2021-05-10 13:04:001385Immuno-AntibodyYesOtherQualitativeColorimetryCalibrant / control sample15LOD0AUCalibrationnot evaluatedCrossreactivitynot evaluatedPrecisionevaluatedReproducibilityevaluatedRobustnessevaluated19942019-nCoV Ag Test (Latex Chromatography Assay)142Innovita Biological TechnologyChinawww.innovita.com.cn/YesCommercialisedNoNoOtherNear POC / POCAntigenNasopharyngeal swab2021-05-10 13:04:001670Immuno-AntigenNoImmunoassayQualitativeValidity test kit15Latex chromatography assayLOD0AUCalibrationEvaluatedCrossreactivityEvaluatedFp0%Fn0%PrecisionEvaluatedAccuracy98.7%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.7%Clinical Specificity100%Type of antigenNucleoprotein17482019-nCoV Ag Rapid Test Kit - REF: CY-F006-AG25780Huachenyang (Shenzhen) Technology Co., Ltd.Chinawww.chenyanglobal.comYesCommercialisedNoNoCassetteOtherAntigenNasal swabNasopharyngeal swabSaliva2021-05-10 13:04:001426Immuno-AntigenYesNoImmunochromatographyQualitative15LOD50U/mlCrossreactivityEvaluatedFp6.6%4 false positives out of 61 testsFn0.22%1 false negatives out of 449 testsPrecisionEvaluatedAccuracy99.02%ReproducibilityEvaluatedRobustnessNot EvaluatedClinical Sensitivity96.67%Type of antigenNucleoprotein1323569Guangdong Longsee Biomedical Co., LtdChinawww.longseemed.comNoCommercialisedNoNoCassetteNear POC / POCAntigenSaliva2021-05-10 13:04:001090Immuno-AntigenYesNoImmunochromatographyOtherColorimetry15LOD0.1AUFp0AUFn1AUAccuracy99%Clinical Sensitivity99%1342569Guangdong Longsee Biomedical Co., LtdChinawww.longseemed.comNoCommercialisedNoNoCassetteNear POC / POCAntigenSaliva2021-05-10 13:04:001110Immuno-AntigenYesNoImmunochromatographyOther15LOD0.1AUFp0AUFn1AUAccuracy95%Clinical Sensitivity99%Type of antigennucleoprotein18732019- nCoV Antigen Rapid Test860Ustar Biotechnologies (Hangzhou) LtdChinaen.bioustar.comYesCommercialisedNoNoCassetteNear POC / POCAntigenOropharyngeal swabSalivaThe 2019-nCoV Antigen Rapid Test is intended for qualitative in-vitro diagnosis of the nucleoprotein antigen of novel coronavirus (2019-nCoV) in the human saliva, oropharyngeal and nasopharyngeal swab samples.2021-05-10 13:04:0018742019- nCoV and Flu A/B Antigen Combo Rapid Test Kit (Colloid Gold Immunoassay)860Ustar Biotechnologies (Hangzhou) LtdChinaen.bioustar.comYesCommercialisedNoNoCassetteNear POC / POCAntigenSalivaThe 2019- nCoV and Flu A/B Antigen Combo Rapid Test is used for in vitro qualitative detection of the nucleoprotein antigen of influenza A, influenza B and Novel Coronavirus (2019- nCoV) in samples from human oropharyngeal swabs, nasopharyngeal swabs and saliva.2021-05-10 13:04:001555Immuno-AntigenNoImmunochromatographyQualitativeColorimetry20LOD960AUCalibrationNot evaluatedCrossreactivityEvaluatedFpNAFnNAPrecisionEvaluatedAccuracy97.94%(96.12%-99.05%）ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity95.65%(91.25%-98.23%)Clinical Specificity99.27%(97.40%-99.91%)Type of antigenNucleoprotein424COVID-19 VIRCLIA IgM+IgA MONOTEST78Vircell S.L.Spainwww.vircell.com/YesCommercialisedNoNoAutomatedManualAntibodyIgMIgAPlasmaSerum2021-05-10 13:04:00344Immuno-AntibodyYesImmunoassayQualitativeChemiluminescence423COVID-19 ELISA IgM+IgA78Vircell S.L.Spainwww.vircell.com/YesCommercialisedNoNoAutomatedManualAntibodyIgMIgAPlasmaSerum2021-05-10 13:04:00353Immuno-AntibodyELISAQualitativeFluorescenceManual or automated Fluorescence 1213Wondof SARS-CoV-2 IgM Antibody Test (Lateral Flow Method)124Guangzhou Wondfo Biotech Co., LtdChinaen.wondfo.com.cn/YesCommercialisedNoNoNear POC / POCAntibodyIgM2021-05-10 13:04:00997Immuno-AntibodyYesImmunoassayQualitative1306Wondof SARS-CoV-2 IgM Antibody Test124Guangzhou Wondfo Biotech Co., LtdChinaen.wondfo.com.cn/YesCommercialisedNoNoNear POC / POCAntibodyIgMPlasmaSerumWhole blood2021-05-10 13:04:001078Immuno-AntibodyYesNoImmunoassayQualitativeColorimetryRapid diagnostic test lateral flow colloidal gold 834Wantai SARS-CoV-2 IgM ELISA49Beijing Wantai Biological Pharmacy Enterprise Co., LtdChinawww.ystwt.cn/YesCommercialisedNoNoAutomatedManualAntibodyIgMSerum2021-05-10 13:04:001165VIROTECH SARS-CoV-2 IgM ELISA614VIROTECH Diagnostics GmbHGermanywww.virotechdiagnostics.comYesCommercialisedNoNoAutomatedManualAntibodyIgMPlasmaSerum https://medsan.shop/media/2a/67/fb/1603871653/MEDsan_SARS_CoV_2_Antigen_Rapid_Test_Flyer.pdf http://www.virotechdiagnostics.com/uploads/tx_multishop/images/cmsfiles/5f05d0d67d93d.pdf2021-05-10 13:04:00950Immuno-AntibodyYesELISAQualitativeOthermanual or automated other Clinical Sensitivity100% IgMClinical Specificity98% IgM98%)]]>957VIDAS SARS-COV-2 IgM56bioMérieux SAFrancewww.biomerieux.com/YesCommercialisedNoNoAutomatedManualAntibodyIgM2021-05-10 13:04:00771Immuno-AntibodyYesImmunoassayQualitative301150SmartEIA COVID-19 RBD IgM591TestLine Clinical Diagnostics s.r.o.Czechiawww.testlinecd.com/YesCommercialisedNoNoAutomatedManualAntibodyIgM2021-05-10 13:04:00936Immuno-AntibodyNoImmunoassayQualitativeFluorescence90Clinical Sensitivity97.5%1105SmartEIA COVID-19 NP IgM591TestLine Clinical Diagnostics s.r.o.Czechiawww.testlinecd.com/YesCommercialisedNoNoMicroplateAutomatedManualAntibodyIgMPlasmaSerum https://www.testlinecd.com/smarteia-covid-19-np-igm?d=2312021-05-10 13:04:00896Immuno-AntibodyYesImmunoassaySemiquantitativeFluorescence90Clinical Sensitivity95.65%Type of antigenSARS-CoV-2 antigen1072Severe Acute Respiratory Syndrome Coronavirus 2 IgM (CLIA)576Shenzhen Mindray Bio-Medical Electronics Co., LtdChinawww.mindray.com/en/index.htmlYesCommercialisedNoNoAutomatedManualAntibodyIgMPlasmaSerum2021-05-10 13:04:00849Immuno-AntibodyImmunoassayChemiluminescenceCalibrationEvaluatedCrossreactivityEvaluatedPrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluated1410SCoV-2 Detect IgM ELISA139InBios InternationalUnited Statesinbios.com/YesCommercialisedNoNoMicroplateLab-basedAntibodyIgMSerum https://inbios.com/scov-2-detect-igm-elisa-kit/2021-05-10 13:04:001173Immuno-AntibodyYesELISAQualitativeMagnetic Electrochemical150Crossreactivity0% IgMfor tested agentsClinical Sensitivity92.5% IgMClinical Specificity98.95% IgM1464SARS-CoV-2-IgM-EIA-BEST680Vector-BestRussiawww.vector-best.ru/en/YesCommercialisedNoNoAntibodyIgMPlasmaSerum2021-05-10 13:04:001215Immuno-AntibodyYesImmunoassayQualitative90LOD1IU/mlCalibrationNot evaluatedCrossreactivityevaluatedPrecisionnot evaluatedAccuracy100% IgMReproducibilityevaluatedRobustnessnot evaluatedClinical Sensitivity100% IgM597SARS-CoV-2 IgM ELISA Kit358Pishtaz Teb DiagnosticsIranwww.pishtazteb.com/enYesCommercialisedNoNoAutomatedManualAntibodyIgMPlasmaSerum2021-05-10 13:04:00504Immuno-AntibodyNoYesELISAQualitativeFluorescence75 CrossreactivityEvaluatedClinical Sensitivity79.4% IgMClinical Specificity97.3% IgM659SARS-CoV-2 IgM ELISA Kit360Ideal Tashkhis Atieh Co.Iranwww.idealdiag.com/en/YesCommercialisedNoNoAutomatedManualAntibodyIgMPlasmaSerum2021-05-10 13:04:00552Immuno-AntibodyYesELISAQualitativeFluorescence75Clinical Sensitivity97.3% IgMClinical Specificity79.4% IgMType of antigennucleocapsid391SARS-CoV-2 IgM Ab Rapid Test262Sure Bio-Tech (USA) Co., LtdUnited Stateswww.surebiotech.com/YesCommercialisedNoNoCardNear POC / POCAntibodyIgM2021-05-10 13:04:00328Immuno-AntibodyYesImmunoassayQualitativeType of antigennucleocapsid protein988SARS-CoV-2 IgM (CLIA)168Maccura Biotechnology Co., LtdChinawww.maccura.com/enYesCommercialisedNoNoCassetteNear POC / POCAntibodyIgMPlasmaSerum2021-05-10 13:04:00876Immuno-AntibodyYesYesImmunoassayQualitativeChemiluminescence20Clinical Sensitivity86.99%Clinical Specificity100%1710SARS-CoV-2 IgM (CLIA)761MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.Chinawww.medcaptain.comYesCommercialisedNoNoCassetteAutomatedManualAntibodyIgMPlasmaSerum2021-05-10 13:04:001390Immuno-AntibodyYesCLIAQualitativeChemiluminescence25LOD0AUCalibrationevaluatedCrossreactivityevaluatedFp1.2% IgMFn6.2% IgMPrecisionevaluatedAccuracy97.4% IgMReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity93.8% IgM2043SARS-CoV-2 IgM (Chemiluminescent Immunoassay)942Suzhou Hybiome Biomedical Engineering Co., Ltd.Chinahttps://www.hybiome.com/YesCommercialisedNoNoOtherAutomatedLab-basedAntibodyIgMPlasmaSerumS-RBD, physical support=Magnetic microparticles2021-05-10 13:04:001721Immuno-AntibodyYesCLIAQualitativeChemiluminescence60LOD0AUCalibrationEvaluatedCrossreactivityEvaluatedFp1.3% IgMFn3% IgMPrecisionEvaluatedAccuracy98.3% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97% IgMClinical Specificity98.7% IgMType of antigenOther1054SARS-CoV-2 IgM526DIALAB GmbHAustriawww.dialab.at/en/home/YesCommercialisedNoNoMicroplateLab-basedAntibodyIgMPlasmaSerum2021-05-10 13:04:00833Immuno-AntibodyYesImmunoassayQualitativeMagnetic Electrochemical70CrossreactivityEvaluatedClinical Sensitivity96.49%(165/171)Clinical Specificity98.15%(742/756)915SARS-CoV IgM ELISA512Ansh LabsUnited Stateswww.anshlabs.com/YesCommercialisedNoNoN.A.Lab-basedAntibodyIgMPlasmaSerum2021-05-10 13:04:00741Immuno-AntibodyNoYesELISAQualitativeFluorescence120CrossreactivityEvaluatedClinical Sensitivity100%Clinical Specificity98.5%447ReSARS CoV-2 IgM ELISA Kit281Zalgen Labs, LLCUnited Stateswww.zalgen.com/NoIn developmentNoNoLab-basedAntibodyIgM2021-05-10 13:04:00360Immuno-AntibodyELISAType of antigennucleocapsid protein476OZO Silver - OZO SARS-CoV-2 IgM Method226OZO LifeUnited Kingdomwww.ozo.life/YesCommercialisedNoNoAutomatedManualAntibodyIgM OZO INDIA SARS-COV-2 IGM/IGG RAPID TEST Kit and OZO Diamond - OZO SARS-CoV-2 IgM + IgG Method are the only two kits available in the company's website2021-05-10 13:04:00398Immuno-AntibodyImmunoassay430Novel Coronavirus IgM antibody test kit (colloidal gold method)273Wuhan Easydiagnosis Biomedicine Co., LtdChinawww.mdeasydiagnosis.com/YesCommercialisedNoNoNear POC / POCAntibodyIgMWhole blood   2021-05-10 13:04:00359Immuno-AntibodyYesImmunoassayQualitativeType of antigennucleoprotein197Novel Coronavirus 2019-nCoV IgM Antibody Detection Kit (Colloidal Gold Method)116Guangzhou Darui Biotechnology Co.,LtdChinawww.daruibiotech.com/NoCommercialisedNoNoNear POC / POCAntibodyIgM2021-05-10 13:04:00153Immuno-AntibodyYesImmunoassayColloidal goldRapid diagnostic test 589NovaLisa COVID-19 (SARS-CoV-2) IgM368NovaTec Immundiagnostica GmbHGermanywww.novatec-id.com/YesCommercialisedNoNoAutomatedManualAntibodyIgMPlasmaSerum2021-05-10 13:04:00498Immuno-AntibodyYesImmunoassayQualitativeFluorescence1133NAISSA SARS-COV-2 IgM585Neomedica d.o.o.Senegalwww.neomedica.rsYesCommercialisedNoNoCartridgeAutomatedAntibodyIgMPlasmaSerum https://neomedica.rs/products/immunodiagnostics/monotest-immunoanalyzer-naissa/naissa-new/2021-05-10 13:04:00915Immuno-AntibodyYesImmunoassayQualitativeSandwich, Double150CalibrationEvaluatedCrossreactivityEvaluatedFp1AUFn0AUPrecisionEvaluatedAccuracy98%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity92.6%1108Microblot-Array COVID-19 IgM591TestLine Clinical Diagnostics s.r.o.Czechiawww.testlinecd.com/YesCommercialisedNoNoDotblotMicroblotAutomatedManualAntibodyIgMPlasmaSerum https://www.trivitron.com/uploads/brochure/15967069992Covid_Kavach_Anti-SARS_CoV-2_Human_IgG_ELISA_eBrochure.pdf https://www.testlinecd.com/microblot-array-covid-19-igm?d=2312021-05-10 13:04:00886Immuno-AntibodyNoYesImmunoassayQuantitativeFluorescence75Clinical Sensitivity97.72%375MAGLUMI 2019-nCoV IgM (CLIA)255Snibe Co., LtdChinawww.snibe.com/YesCommercialisedNoNoAutomatedManualAntibodyIgMPlasmaSerum2021-05-10 13:04:00319Immuno-AntibodyYesImmunoassayQuantitative301033Maccura SARS-CoV-2 IgM168Maccura Biotechnology Co., LtdChinawww.maccura.com/enYesCommercialisedNoNoCardNear POC / POCAntibodyIgMPlasmaSerum2021-05-10 13:04:00789Immuno-AntibodyYesYesImmunoassayQualitativeChemiluminescence20Clinical Sensitivity86.99%Clinical Specificity100%67Kewei COVID-19 IgM antibody ELISA Test Kit43Beijing Kewei Clinical Diagnostic Reagent IncChinaen.keweidiagnostic.com/YesCommercialisedNoNoN.A.AutomatedManualAntibodyIgMPlasmaSerum2021-05-10 13:04:00365Immuno-AntibodyNoYesELISAQualitativeCapture60Accuracy96% IgMClinical Sensitivity90.83% IgMClinical Specificity99.6% IgM1080iFlash-SARS-CoV-2 IgM379SHENZHEN YHLO BIOTECH CO., LtdChinawww.szyhlo.comYesCommercialisedNoNoAutomatedManualAntibodyIgMPlasmaSerum https://pdf.medicalexpo.com/pdf/shenzhen-yhlo-biotech-co-ltd/clia-iflash-3000/107786-227346.html2021-05-10 13:04:00863Immuno-AntibodyYesImmunoassayQualitativeChemiluminescence30LOD10U/mlCalibrationEvaluatedCrossreactivityEvaluatedPrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity80.8%7 daysClinical Sensitivity92.3%8-14 days1124Human anti-SARS-CoV-2 IgM ELISA367MP BiomedicalsUnited Stateswww.mpbio.com/YesCommercialisedNoNoMicrotiter plateAutomatedManualAntibodyIgMOther biological fluidsPlasmaTissue homogenates https://www.mpbio.com/us/human-anti-sars-cov-2-igm-elisa-kit2021-05-10 13:04:00906Immuno-AntibodyYesELISAQuantitative566GenSure COVID-19 IgM Rapid Test (REF: P2001)340GenSure Biotech IncChinawww.gensbio.com/YesCommercialisedNoNoCassetteNear POC / POCAntibodyIgMWhole blood2021-05-10 13:04:00452Immuno-AntibodyYesNoImmunoassayQualitative15Clinical Sensitivity95%Clinical Specificity95%1672Foresight SARS-CoV-2 IgM EIA Test Kit683ACON Laboratories, IncUnited Stateswww.aconlabs.comYesCommercialisedNoNoAutomatedManualAntibodyIgMPlasmaSerum2021-05-10 13:04:001351Immuno-AntibodyYesImmunoassayQualitativeOther30Manual or automated other LOD1AUCalibrationevaluatedCrossreactivityevaluatedPrecisionevaluatedAccuracy97.72%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity90.14%1425Foresight SARS-CoV-2 IgM565Acon Biotech (Hangzhou) Co., LtdChinawww.aconbio.com/YesCommercialisedNoNoMicroplateLab-basedAntibodyIgMPlasmaSerum https://www.aconlabs.com.cn/en/ACON/687.html2021-05-10 13:04:001184Immuno-AntibodyYesImmunoassayQualitativeMagnetic Electrochemical75Accuracy96.1%Clinical Sensitivity88.6%Clinical Specificity97.8%982ENZY-WELL SARS-CoV-2 IgM543DIESSE Diagnostica Senese SPAItalywww.diesse.it/YesCommercialisedNoNoAutomatedManualAntibodyIgMPlasmaSerum2021-05-10 13:04:00788Immuno-AntibodyYesImmunoassayQualitativeFluorescence135CrossreactivityEvaluatedClinical Sensitivity87.7%Clinical Specificity97%1138EIA COVID-19 RBD IgM591TestLine Clinical Diagnostics s.r.o.Czechiawww.testlinecd.com/YesCommercialisedNoNoAutomatedManualAntibodyIgMPlasmaSerumPending patent issues 2021-05-10 13:04:00927Immuno-AntibodyYesImmunoassayQualitativeFluorescenceSample preparation90Clinical Sensitivity97.5%1102EIA COVID-19 NP IgM591TestLine Clinical Diagnostics s.r.o.Czechiawww.testlinecd.com/YesCommercialisedNoNoAutomatedManualAntibodyIgMPlasmaSerum https://www.testlinecd.com/eia-covid-19-np-igm2021-05-10 13:04:00893Immuno-AntibodyYesImmunoassaySemiquantitativeFluorescence90Clinical Sensitivity95.65%158EDI Novel Coronavirus COVID-19 IgM ELISA Kit94Epitope Diagnostics, IncUnited Stateswww.epitopediagnostics.com/YesCommercialisedNoNoAutomatedManualAntibodyIgMPlasmaSerum2021-05-10 13:04:00122Immuno-AntibodyNoYesELISAQuantitativeFluorescence120Clinical Sensitivity100% IgMClinical Specificity100% IgM1416Diazyme DZ-LITE SARS-CoV-2 IgM CLIA kit390Diazyme LaboratoriesUnited Stateswww.diazyme.com/NoCommercialisedNoNoLab-basedAntibodyIgMPlasmaSerum PROPOSED BY BARBARA https://www.diazyme.com/images/covid19/5-EUA200922_Diazyme.DZLite.IgM.PackageInsert_08172020.pdf2021-05-10 13:04:001177Immuno-AntibodyYesCLIAQualitativeChemiluminescenceCrossreactivity0%for tested agentsClinical Sensitivity94.4%Clinical Specificity98.3%149COVID-19 lgM, EIA-614789DRG International, IncUnited Stateswww.drg-international.com/YesCommercialisedNoNoNear POC / POCAntibodyIgMPlasmaSerum2021-05-10 13:04:00113Immuno-AntibodyNoYesImmunoassayQuantitativeFluorescence120LOD5U/mlClinical Sensitivity100% IgGClinical Sensitivity45% IgMClinical Specificity100% IgGClinical Specificity97.7% IgM1328COVID-19 IgM ELISA410Monocent, IncUnited Stateswww.monocent.comYesCommercialisedNoNoAutomatedManualAntibodyIgMPlasmaSerum2021-05-10 13:04:001097Immuno-AntibodyYesELISAQualitative85Accuracy99.44% IgMClinical Sensitivity96% IgMType of antigennucleoprotein478COVID-19 IgM Antibody Rapid Test Kit303Hecin Scientific, IncChinawww.hecin-scientific.cn/YesCommercialisedNoNoNear POC / POCAntibodyIgM2021-05-10 13:04:00400Immuno-AntibodyYesImmunoassay842COVID-19 (SARS-CoV-2) IgM ELISA489Demeditec Diagnostics GmbHGermanywww.demeditec.com/YesCommercialisedNoNoAutomatedManualAntibodyIgMPlasmaSerum2021-05-10 13:04:00691Immuno-AntibodyNoYesELISAQualitativeFluorescenceCrossreactivityEvaluatedClinical Sensitivity57.14% IgMClinical Specificity100% IgM538BioProbes Srl COV19M.CE - ELISA COVID 19 IgM341DIA.PRO Diagnostic Bioprobes SrlItalywww.diapro.it/YesCommercialisedNoNoAutomatedManualAntibodyIgMPlasmaSerum2021-05-10 13:04:00454Immuno-AntibodyYesELISAQualitativeFluorescence454BIOCELL COVID-19 IgM ELISA test292Zhengzhou Humanwell Biocell Biotechnology Co., LtdChinawww.cnbiocell.com/YesCommercialisedNoNoAutomatedManualAntibodyIgMPlasmaSerum2021-05-10 13:04:00380Immuno-AntibodyYesELISAQualitativeFluorescenceType of antigennucleocapsid antigen1500Bio-Shield 2019-nCov IgM688Prognosis BiotechGreecewww.prognosis-biotech.com/YesCommercialisedNoNoAutomatedManualAntibodyIgMPlasmaSerumWhole blood2021-05-10 13:04:001250Immuno-AntibodyYesImmunoassayQualitativeOther90LOD1AUCalibrationevaluatedCrossreactivityevaluatedFp1%Fn6%PrecisionevaluatedAccuracy99.06%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity92.31%773Atlas COVID-19 IgM Elisa Kit314Atlas MedicalUnited Kingdomatlas-medical.com/YesCommercialisedNoNoAutomatedManualAntibodyIgMSerum2021-05-10 13:04:00627Immuno-AntibodyYesELISAQualitative70Manual or automated 1627Anti-SARS-CoV-2 IgM ELISA723MediagnostGermanymediagnost.deNoCommercialisedNoNoStripLab-basedAntibodyIgMPlasmaSerum2021-05-10 13:04:001307Immuno-AntibodyELISAAccuracy85%Clinical Sensitivity66.7%CI range: 66.7-75%Clinical Specificity98%Type of antigenRBD1093AESKULISA SARS-CoV-2 NP IgM586Aesku.DiagnosticsGermanywww.aesku.comYesCommercialisedNoNoAutomatedManualAntibodyIgMPlasmaSerumhttps://www.aesku.com/index.php/diagnostics/aeskulisa-elisa-test-kits/infectious-serology-elisa/item/3992021-05-10 13:04:00873Immuno-AntibodyYesImmunoassayQuantitativeMagnetic Electrochemical1193Accudiag SCoV-2 IgM ELISA Kit582Diagnostic Automation/Cortez Diagnostics, IncUnited Stateswww.rapidtest.comYesCommercialisedNoNoAutomatedManualAntibodyIgMSerum2021-05-10 13:04:00975Immuno-AntibodyNoELISAQualitative150Manual or automated Accuracy98.95% IgMClinical Sensitivity92.5% IgM10852019-nCoV IgM Control379SHENZHEN YHLO BIOTECH CO., LtdChinawww.szyhlo.comYesCommercialisedNoNoOtherAntibodyIgM2021-05-10 13:04:00868Immuno-AntibodyImmunoassayCalibrant / control sample8452019-nCOV IgM Antibody kit (ELISA)86Dynamiker Biotechnology (Tianjin) Co., LtdChinaen.dynamiker.com/YesCommercialisedNoNoAutomatedManualAntibodyIgM2021-05-10 13:04:00694Immuno-AntibodyELISANot found3572019-nCoV IgM Antibody Diagnostic Kit (Colloidal gold)245Shanghai Chemtron Biotech Co. LtdChinawww.chemtronbio.com/YesCommercialisedNoNoNear POC / POCAntibodyIgM2021-05-10 13:04:00308Immuno-AntibodyYesImmunoassay622019-nCoV IgM Antibody Determination Kit38Beijing Diagreat Biotechnologies Co., LtdChinawww.diagreat.com/YesCommercialisedNoNoNear POC / POCAntibodyIgMWhole blood2021-05-10 13:04:0044Immuno-AntibodyYesYesImmunoassayQualitativeFluorescence15CrossreactivityReported874SARSPLEX: Anti-SARS-CoV-2 IgM / IgG / IgA ELISA (measure individual Ig easily)482TeztedFinlandwww.tezted.com/YesCommercialisedNoNoAutomatedManualAntibodyIgGIgMIgA2021-05-10 13:04:00713Immuno-AntibodyELISAManual or automated Not found Not found 793pGOLD COVID-19 IgG/IgM/IgA Microarray Test188Nirmidas Biotech, IncUnited Stateswww.nirmidas.com/NoCommercialisedNoNoLab-basedAntibodyIgGIgMIgA Information provided by the manufacturer2021-05-10 13:04:00636OtherOther LOD1.6ng/mL815COVISCREEN test for detection of IgM/IgG/IgA antibodies564Zephyr Biomedicals-Tulip GroupIndiawww.tulipgroup.com/Zephyr_New/comp_profile.htmYesCommercialisedNoNoCassetteAutomatedManualAntibodyIgGIgMIgAWhole blood2021-05-10 13:04:00826Immuno-AntibodyNoImmunoassayQualitative202005ACCEL ELISA COVID-19 kit922Plexense, Inc.South Koreawww.plexense.comYesCommercialisedNoNoMicroplateManualSemi-automatedAntibodyIgGIgMIgAPlasmaCalculate positive and negative results by dividing each sample’s or control’s reaction value at OD 650 nm by the cutoff value determined during the assay procedure. The cut-off value is determined by + 3 SD from the average OD of triplicated negative controls.2021-05-10 13:04:001683Immuno-AntibodyYesELISAQualitativeEnzyme-linkedN.A.45LOD4.3AUCalibrationNot evaluatedCrossreactivityEvaluatedFp2AUFn1AUPrecisionEvaluatedAccuracy98.5%(IgG,IgM,IgA)ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity98%(IgG,IgM,IgA)Clinical Specificity99%(IgG,IgM,IgA)Type of antigenNucleoprotein10263gamma COVID-19 IgA / IgM / IgG608TregenaItalywww.3gamma.it/YesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMIgAWhole blood14 days from symptom onset to blood collectionMade in Taiwan http://www.3gamma.it/1/upload/brochure_3_gamma.pdf]]>2021-05-10 13:04:00938Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry20Clinical Sensitivity99%Clinical Specificity95.2%633Willi Fox Covid-19 IgM/ IgG rapid test549Willi Fox GmbHSwitzerlandwillifox.com/YesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:00796Immuno-AntibodyYesNoImmunoassayQualitativeNot found15Clinical Sensitivity98%Clinical Specificity99%428VivaDiag COVID-19 IgM/IgG Rapid Test175VivaChek Biotech (Hangzhou) Co., LtdChinawww.vivachek.com/YesCommercialisedNoNoLateral flowNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:00231Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15Type of antigennucleoprotein103ViroTrack Sero COVID-19 IgA+IgM/IgG Ab60BluSense Diagnostics ApSDenmarkblusense-diagnostics.com/YesCommercialisedNoNoCardNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:04:0073Immuno-AntibodyYesYesImmunoassaySemiquantitativeOther13Patented IMA technology CalibrationEvaluatedCrossreactivityEvaluatedFp1.15%1 false positive in a cohort of 87 negative samplesFn17.14%6 false negatives in a cohort of 35 positive samplesPrecisionEvaluatedAccuracy93.4 (IgA+IgM); 93.4 (IgG); 94.3 (IgA+IgM/IgG)Accuracy93.4% IgGReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity80 (IgA+IgM); 77.1 (IgG); 82.9 (IgA+IgM/IgG)Clinical Sensitivity77.11723Toyo SARS-CoV-2 IgM/IgG Ab Test758TurklabTurkeywww.turklab.com.tr/YesCommercialisedNoNoLateral flowNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:18:201403Immuno-AntibodyYesNoImmunoassayQualitative15LOD0AUCalibrationnot evaluatedCrossreactivityevaluatedPrecisionnot evaluatedAccuracy96.17% IgGAccuracy93.33% IgMReproducibilityevaluatedRobustnessnot evaluatedClinical Sensitivity92.88% IgGClinical Sensitivity87.54% IgMType of antigennucleoprotein1959Toda Coronadiag +681TODA PHARMAFrancehttps://www.todapharma.com/YesCommercialisedNoNoCassetteLateral flowNear POC / POCAntibodyIgGIgMPeripheral bloodPlasmaSerumVenous whole bloodWhole bloodWhole blood with anti-coagulantsPlease kindly note that the above mentioned performance rates are valid for IgG and IgM. Please kindly note that the performance rates are based on specimen which have been assessed between Day 14 and Day 19 after onset of symptoms.2021-05-10 13:04:001635Immuno-AntibodyNoImmunochromatographyQualitativeSandwich, Double15LOD0AUCalibrationEvaluatedCrossreactivityEvaluatedFp0%Fn0%PrecisionEvaluatedAccuracy100% IgGAccuracy100% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100% IgGClinical Sensitivity100% IgMClinical Specificity100% IgGClinical Specificity100% IgMType of antigenNucleoprotein77Tigsun COVID-19 Combo IgM/IgG Rapid Test (Lateral Flow Method)47Beijing Tigsun Diagnostics Co. LtdChinawww.tigsun.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:0054Immuno-AntibodyYesNoImmunoassayQualitative1073Test Rapid IgG/IgM 2019-nCoV577DDS DIAGNOSTICRomaniawww.ddsdiagnostic.comYesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood https://ddsdiagnostic.com/test-rapid-coronavirus-romania/2021-05-10 13:04:00850Immuno-AntibodyYesNoImmunochromatographyQualitativeSample preparation10LOD0AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0AU0Fn0AUPrecisionEvaluatedAccuracy98.82% IgGAccuracy98.88% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100% IgGClinical Sensitivity100% IgMClinical Specificity98% IgGClinical Specificity97.96% IgM524Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Ab Test322Biocan Diagnostics IncCanadawww.rapidtest.ca/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:00426Immuno-AntibodyYesNoImmunoassayQualitative15Rapid diagnostic test Lateral Flow 1336TBG SARS-CoV-2 IgG/IgM Rapid Test Kit406TBG Biotechnology Corp.Australiawww.tbgbio.com/enYesCommercialisedNoNoCardNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:04:00559Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15749SureScreen COVID19 IgM/IgG Rapid Test Cassette288SureScreen DiagnosticsUnited Kingdomwww.surescreen.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:00817Immuno-AntibodyYesNoImmunoassayQualitativeNot found10CrossreactivityEvaluatedAccuracy97.8% IgMAccuracy99.6% IgGClinical Sensitivity91%Clinical Specificity99%346STANDARD Q COVID-19 IgM/IgG Duo Test224SD BIOSENSOR IncSouth Koreahttp://sdbiosensor.com/xe/YesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:00288Immuno-AntibodyYesNoImmunoassayQualitative10LOD20µg/ml(IgM, IgG)CalibrationNot EvaluatedCrossreactivityEvaluatedPrecisionNot EvaluatedAccuracyNot EvaluatedRobustnessNot EvaluatedClinical Sensitivity99.1%Clinical Specificity95.09%838Smart COVID-19 IgM/IgG RDT488Cell ID Pte LtdSingaporewww.cid.com.sg/YesCommercialisedNoNoAutomatedManualAntibodyIgGIgM2021-05-10 13:04:00688Immuno-AntibodyImmunoassayNot found1039Sienna COVID-19 IgG/IgM Rapid Test Cassette567Salofa OyFinlandwww.salofa.com/YesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgM2021-05-10 13:04:00832Immuno-AntibodyYesImmunoassay388SGTi-flex COVID-19 IgM/IgG (RDT)261Sugentech, IncSouth Koreasugentech.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:00326Immuno-AntibodyYesImmunoassayQualitativeColorimetry1918Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV-2) IgM/IgG Antibody Assay Kit by Colloidal Gold Method168Maccura Biotechnology Co., LtdChinawww.maccura.com/enYesCommercialisedNoNoCardCassetteLateral flowManualNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood/2021-05-10 13:18:201594Immuno-AntibodyNoImmunochromatographyQualitativeColorimetry10LOD0AUCalibrationNot evaluatedCrossreactivityEvaluatedFpNoneFnNonePrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.39%Clinical Specificity97.01%Type of antigenOther1038SeroFlash SARS-CoV-2 IgM/IgG Antibody Detection Kit570Epigentek Group IncUnited Stateswww.epigentek.comNoCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMWhole blood I could not find CE-IVD proof2021-05-10 13:04:00962Immuno-AntibodyYesNoImmunoassayQualitativeColloidal goldCrossreactivityReportedAccuracy92.19%Clinical Sensitivity97.8%Clinical Specificity100%1044SeroFlash SARS-CoV-2 IgG/IgM ELISA Fast Kit570Epigentek Group IncUnited Stateswww.epigentek.comYesCommercialisedNoNoLab-basedAntibodyIgGIgMPlasmaSerum2021-05-10 13:04:00837Immuno-AntibodyNoYesELISAQualitativeFluorescenceSample preparation45LOD0.002µg/mlCrossreactivityEvaluatedPrecisionInter-assay 8%; Intra assay: 12%.992Screen Test Covid-19 - 2019-NCoV IgG/IgM Rapid Test Cassette701SCREEN ITALIA S.r.l.Italywww.screenitalia.itYesCommercialisedNoNoLateral flowNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:18:20772Immuno-AntibodyYesNoImmunoassayQualitative10CrossreactivityEvaluatedPrecision99%Accuracy98.6% IgGAccuracy92.9% IgMClinical Sensitivity100% IgGClinical Sensitivity85% IgMClinical Specificity98% IgGClinical Specificity96% IgM1015SARTS-CoV2 IgM/IgG antibody test605Chinawww.beixi.com/YesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMWhole blood https://www.medicalexpo.es/prod/shanghai-b-c-biological-technology-co-ltd/product-129056-952556.html2021-05-10 13:04:00931Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15Clinical Sensitivity96.6%Clinical Specificity93.8%265SARS-CoV-2(COVID19)IgM/IgG Antibody Fast Detection Kit166LOMINA AGSwitzerlandwww.lomina.ch/YesCommercialisedNoNoCardAutomatedManualAntibodyIgGIgMWhole blood2021-05-10 13:04:00220Immuno-AntibodyNoImmunoassayQualitativeColorimetry51620111GenScriptNetherlandswww.genscript.comNoCommercialisedNoNoLab-basedAntibodyIgGIgMPlasmaSerum2021-05-10 13:04:001300Immuno-AntibodyELISAFp0%Fn0%Type of antigenspike protein485SARS-CoV-2 Rapid TesIgM/IgG318Pharmact (Berlin)Germanypharmact-health.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:00716Immuno-AntibodyYesNoImmunoassayQualitative20Precision99% IgMPrecision99.2% IgGClinical Sensitivity98.1% IgMClinical Sensitivity99.5% IgGClinical Specificity99.5% IgMClinical Specificity99.7% IgG500SARS-CoV-2 rapid combined IgM/IgG antibody test kit317Jiangsu Medomics Medical TechnologiesChinawww.cn-hos.com/YesCommercialisedNoNoLateral flowNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:00419Immuno-AntibodyYesNoImmunoassayQualitative15Clinical Sensitivity88.66%Clinical Specificity90.63%1461SARS-CoV-2 IgM/IgG Rapid Test Kit (Colloidal Gold)677Triplex International Biosciences Co., LtdChinawww.tibchina.com/index_en.aspxYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMSerumWhole blood2021-05-10 13:04:001206Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15LOD-1AUCalibrationevaluatedCrossreactivityevaluatedFp0AUFn0AUPrecisionevaluatedAccuracy88.88% IgGAccuracy93.88% IgMReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity75.3% IgGClinical Sensitivity87.65% IgMType of antigennucleoprotein1889SARS-CoV-2 IgM/IgG Duo Test Kit (Colloidal Gold)863Wuhan HealthCare Biotechnology Co., Ltd.Chinawww.health-carebiotech.comYesCommercialisedNoNoAntibodyIgGIgMPlasmaSerumfor more infor, please contact cs@healthcare-bio.com2021-05-10 13:04:001567Immuno-AntibodyNoImmunoassayQualitativeColorimetryOther10LODAU0.00001CalibrationEvaluatedCrossreactivityEvaluatedFp3.16%5 OF 158Fn12.71%15 of 118PrecisionEvaluatedAccuracy92%(IgM/IgG)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity91%(IgM/IgG)Clinical Specificity95%(IgM/IgG)Type of antigenNucleoprotein1161SARS-CoV-2 IgM/IgG Duo Test (Colloidal Gold)609Shenzhen Dymind Biotechnology Co., LtdChinawww.dymind.comYesCommercialisedNoNoManualAntibodyIgGIgMSerumWhole blood2021-05-10 13:04:00942Immuno-AntibodyNoImmunoassayQualitativeColorimetry15Fp5AUFn10AU673SARS-CoV-2 IgM/IgG Combo Rapid Test Kit392Guanxhow Fenghua Bioengineering, Co. LTDChinawww.bio-fenghua.com/YesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:00540Immuno-AntibodyYesNoImmunoassayQualitativeType of antigenSARS-CoV-2 N-, S1- and S2-Proteine87SARS-CoV-2 IgM/IgG antibody test kit (Colloidal Gold Method)53BIOHIT HealthCare (Hefei) Co., LtdChinawww.biohit.cnYesCommercialisedNoNoStripNear POC / POCAntibodyIgGIgM2021-05-10 13:04:0061Immuno-AntibodyYesNoImmunoassayQualitativeColloidal gold15Clinical Sensitivity97.5%2059SARS-CoV-2 IgM/IgG Antibody Test Kit (colloidal gold method)949Hangzhou Bioer Technology Co., Ltd.Chinahttp://www.bioer.com.cn/en/YesCommercialisedNoNoCassetteManualAntibodyIgGIgMPlasmaSerumhttp://www.bioer.com.cn/en/ LoD: 250U/mL2021-05-17 10:15:211739Immuno-AntibodyNoImmunochromatographyQualitativeSandwichColloidal goldValidity test kit15LOD250CalibrationEvaluatedCrossreactivityEvaluatedFp0.3%Fn4.9%PrecisionEvaluatedAccuracy98.3%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity95.1%Clinical Specificity99.6%Type of antigenOther1637SARS-CoV-2 IgM/IgG ANTIBODY TEST KIT733Hefei Biohit HealthcareChinawww.biohit.cn/Antibody/index.aspxYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:04:001317Immuno-AntibodyYesNoImmunoassayColloidal gold15Clinical Sensitivity96.7%Clinical Specificity95%1204SARS-CoV-2 IgM/IgG Antibody Test (Colloidal Gold)44Joinstar Biomedical Technology Co., LtdChinawww.joinstar.cnYesCommercialisedNoNoLateral flowNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:04:0051Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry10LOD0AUFp0%No false positives in 112 samples vs PCR Fn8.93%10 False negatives in 112 samples vs PCRAccuracy91.07%IgG+IgMClinical Sensitivity89%90 samples which were PCR positive1340SARS-COV-2 IGM/IGG ANTIBODY RAPID TEST286Qingdao Hightop Biotech Co., LtdChinawww.hightopbio.com/YesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:04:001116Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15Accuracy93% IgGAccuracy82% IgMClinical Sensitivity93% IgGClinical Sensitivity82% IgM1770SARS-CoV-2 IgM/IgG Antibody Assay Kit (Immunochromatography)792Wuhan Life Origin Biotech Joint Stock Co., Ltd.Chinawww.szybio.comYesCommercialisedNoNoCassetteLateral flowNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:04:001449Immuno-AntibodyYesYesImmunochromatographyQualitative15LOD0U/mlCalibrationEvaluatedCrossreactivityEvaluatedFp1%(1/100),95%CI(0.03%-5.45%)Fn12%(24/200),95%CI(7.84%-17.33%)Accuracy91.67%(275/300),95%CI(87.94%-94.53%)(IgM , IgG)ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity88%(176/200）, 95%CI（82.77%-91.80%）(IgM , IgG)871SARS-CoV-2 IgM/IgG Antibody (Colloidal Gold)239Shanghai Kehua Bio-engineering Co., LtdChinawww.skhb.com/YesCommercialisedNoNoAutomatedManualAntibodyIgGIgMWhole blood http://www.deltachemie.it/news.php?id=36 "Diagnotic kit for" was removed from the name of the kit2021-05-10 13:04:00848Immuno-AntibodyNoImmunoassayQualitativeColorimetry151690SARS-CoV-2 IgM/IgG Ab Test758TurklabTurkeywww.turklab.com.tr/YesCommercialisedNoNoLateral flowNear POC / POCAntibodyIgGIgM2021-05-10 13:18:201369Immuno-AntibodyYesNoImmunoassayQualitative15LOD15AU390SARS-CoV-2 IgM/IgG Ab Rapid Test262Sure Bio-Tech (USA) Co., LtdUnited Stateswww.surebiotech.com/YesCommercialisedNoNoCardNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:00327Immuno-AntibodyYesNoImmunoassayQualitative15Type of antigennucleocapsid protein1576SARS-CoV-2 IgM/IgG (GICA) Test698GenaBio Diagnostics Inc.United Stateswww.genabio.comYesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:18:201255Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry10Rapid diagnostic test cassette colloidal gold LOD1CalibrationevaluatedCrossreactivityevaluatedFp0Fn1.65%PrecisionevaluatedAccuracy100% IgGAccuracy100% IgMReproducibilityevaluatedRobustnessnot evaluatedClinical Sensitivity100% IgMClinical Sensitivity100% IgGClinical Specificity99.2%combinedType of antigennucleoprotein637SARS-CoV-2 IgM and IgG Antibody Assay Kit384Zybio IncChinawww.zybio.com/enYesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMPlasmaSerum2021-05-10 13:04:00797Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry10285477United Stateswww.mokobious.com/YesCommercialisedNoNoCassetteAutomatedManualAntibodyIgGIgMPlasmaSerum2021-05-10 13:04:00660Immuno-AntibodyYesImmunoassayQualitativeFluorescence60Clinical Sensitivity89.52%Clinical Specificity99.36%1661SARS-Cov-2 IgG/M Antibody Assay kit by Colloidal Gold Method743Sichuan Xincheng Biological Co., LTDChinawww.xinchengbio.com/en/YesCommercialisedNoNoCardNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:04:001340Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15LOD500AUCalibrationevaluatedCrossreactivityevaluatedFp0.71%Fn4.37%PrecisionevaluatedAccuracy92.3% IgMAccuracy97.3% IgGReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity85.6% IgMClinical Sensitivity95.6% IgG828SARS-CoV-2 IgG/IgM Rapid Test (CE-IVD)565Acon Biotech (Hangzhou) Co., LtdChinawww.aconbio.com/YesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:001548Immuno-AntibodyImmunoassay985SARS-CoV-2 IgG/IgM Rapid Test Device719Zhuhai Encode Medical Engineering Co., LtdChinawww.encode.com.cn/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgM2021-05-10 13:18:20790Immuno-AntibodyYesImmunoassayType of antigennucleocapsid438SARS-CoV-2 IgG/IgM Rapid Qualitative Test Kit756Xiamen Biotime Biotechnology Co., Ltd.Chinawww.biotime.cn/En_YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:18:20704Immuno-AntibodyYesImmunoassayQualitativeColorimetry192SARS-CoV-2 IgG/IgM Kit (manual)117Goldsite Diagnostics IncChinaen.goldsite.com.cn/YesCommercialisedNoNoStripAutomatedManualAntibodyIgGIgMWhole blood2021-05-10 13:04:00154Immuno-AntibodyYesNoImmunoassayQualitativeFluorescence12919SARS-CoV-2 IgG/IgM CLIA Microparticle detection kit513Autobio Diagnostics Co., LtdChinawww.autobio.com.cn/en/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgM2021-05-10 13:04:00744Immuno-AntibodyYesYesImmunoassayQualitativeChemiluminescenceRapid diagnostic test Not found Chemiluminescence 697SARS-CoV-2 IgG/igM Antibody Detection Kit425Beroni GroupAustraliawww.beronigroup.comYesCommercialisedNoNoLab-basedAntibodyIgGIgM2021-05-10 13:04:00581Immuno-AntibodyImmunoassay616SARS-Cov-2 IgG/IgM Antibody Assay Kit by Immunofluorescence Chromatography Method743Sichuan Xincheng Biological Co., LTDChinawww.xinchengbio.com/en/YesCommercialisedNoNoCardNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:00479Immuno-AntibodyYesYesChromatographyQualitativeFluorescence8Accuracy93.3%Type of antigenN-protein, S2-ECD, S1-RBD; N-protein, S2-ECD, S1-RBD; N-protein, S2-ECD, S1-RBD1712SARS-CoV-2 IgG/IgM (GICA)761MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.Chinawww.medcaptain.comYesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMPlasmaWhole blood2021-05-10 13:04:001392Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15LOD0AUCalibrationnot evaluatedCrossreactivityevaluatedFp3.7%Fn0%PrecisionevaluatedAccuracy96.3%(IgG, IgM)ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity100%(IgG, IgM)1227SARS-CoV-2 IgG and IgM Antibody Combined Test Kit (Fluorescence Immunoassay)563Shenzhen Microprofit Biotech Co., LtdChinawww.microprofit-bio.com/YesCommercialisedNoNoLab-basedAntibodyIgGIgM2021-05-10 13:04:001012Immuno-AntibodyImmunoassay808563Shenzhen Microprofit Biotech Co., LtdChinawww.microprofit-bio.com/YesCommercialisedNoNoAutomatedManualAntibodyIgGIgMWhole blood2021-05-10 13:04:00824Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry10254SARS-CoV-2 Antibody IgM/IgG Testing Kit159Kurabo Industries LtdJapanwww.kurabo.co.jp/english/NoIn developmentNoNoStripNear POC / POCAntibodyIgGIgM2021-05-10 13:04:00210Immuno-AntibodyYesImmunoassay151017SARS-CoV-2 Antibody (IgM/IgG)147InTec Products, IncChinawww.intecasi.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgM2021-05-10 13:04:00812Immuno-AntibodyYesImmunoassay946SARS-CoV- IgM IgG Test Kit (Colloidal Gold)469Shenzhen GeneBioHealth Co., LtdChinawww.genebiohealth.com/en/YesCommercialisedNoNoCassetteAutomatedManualAntibodyIgGIgMWhole blood2021-05-10 13:04:00860Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry10777SARS CoV-2 IgG/IgM Ab Rapid Test466Biogenix Inc Pvt LtdIndiawww.biogenixinc.com/NoCommercialisedNoNoNear POC / POCAntibodyIgGIgM2021-05-10 13:04:00645Immuno-AntibodyYesImmunoassayRapid diagnostic test Not found Not found 1047Salocor COVID-19 IgG/IgM Rapid Test Cassette567Salofa OyFinlandwww.salofa.com/YesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:04:00840Immuno-AntibodyYesImmunoassayQualitative15CrossreactivityevaluatedClinical Sensitivity93.7% IgGClinical Sensitivity94.9% IgM109Rona 19 Screen Coronavirus (SARS-CoV-2) IgG/IgM Rapid Test61Bright Line ResearchUnited Stateswww.brightlineresearch.com/NoIn developmentNoNoNear POC / POCAntibodyIgGIgM2021-05-10 13:04:0076Immuno-AntibodyYesImmunoassayRapid diagnostic test 1583RapidFor SARS-CoV-2 IgG/IgM Test Kit678Vitrosens Biotechnology Co., LtdTurkeywww.vitrosens.comYesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:18:201263Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15LOD100%CalibrationevaluatedCrossreactivityevaluatedFp2AUFn1AUPrecisionevaluatedAccuracy99%Accuracy95.4% IgMAccuracy97.3% IgGReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity98.2%Clinical Sensitivity92.3% IgMClinical Sensitivity96.6% IgGClinical Specificity98.3% IgMClinical Specificity98.08% IgG1024RAPID TEST SARS-CoV-2 IgM/IgG GOLD540Technogenetics SRLItalywww.technogenetics.itYesCommercialisedNoNoCardNear POC / POCAntibodyIgGIgMWhole blood https://www.testlinecd.com/file/1580/COVID-19_AN_NEW%20(002).pdf?version=202008131535 https://www.technogenetics.it/en/products-1/covid-192021-05-10 13:04:00783Immuno-AntibodyYesNoImmunoassayQualitative15Type of antigenCombination of selected parts of the specific antigens of SARS-CoV-2 (NCP, RBD, Spike S2, E, ACE2, PLPro protein) and antigens for exclusion cross-reactivity with other endemic coronaviruses (MERS-CoV, SARS-CoV, HCoV 229E Np, HCoV NL63 Np).1043Rapid test for IgM/IgG Antibody to SARS-CoV-2553Jiangsu Dabo Pharmaceutical Co., LtdChinawww.dabloodpharmaceutical.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgM Data provided by the Manufacturer2021-05-10 13:04:00804Immuno-AntibodyYesNoImmunoassayQualitative15CrossreactivityEvaluatedAccuracy98%RobustnessEvaluated229Rapid SARS-CoV-2 Antibody (IgM/IgG)147InTec Products, IncChinawww.intecasi.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgM2021-05-10 13:04:00190Immuno-AntibodyYesImmunoassay110Rapid Response COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma)62BTNX IncCanadawww.btnx.com/NoCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:04:0077Immuno-AntibodyYesImmunoassayRapid diagnostic test 2033Rapid Response COVID-19 IgG/IgM Rapid Test Device62BTNX IncCanadawww.btnx.com/YesCommercialisedNoNoCassetteLateral flowNear POC / POCAntibodyIgGIgMPlasmaSerumWhole bloodThe Rapid Response COVID-19 IgG/IgM Rapid Test Device has been CE marked since April of 2020. Since then various independent evaluations have been completed at various EU member state organizations. The "COVID-19 In Vitro Diagnostic Medical Devices" mentions that the product is not CE marked. The name of the product has been slightly changed since the first CE marking which could be the cause of this being missed. Could you please check and update the list during the next meeting of JRC? Thank you, Khasim Technical Operations Manager khasim@btnnx.com2021-05-10 13:18:201711Immuno-AntibodyNoImmunochromatographyQualitativeSandwich15LOD210CalibrationEvaluatedCrossreactivityEvaluatedFp2% IgMFp3% IgGFn5% IgMFn1% IgGPrecisionEvaluatedAccuracy97.7% IgMAccuracy98.7% IgGReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.7% IgMClinical Sensitivity98.8% IgGClinical Specificity99.1% IgMClinical Specificity98.7% IgGType of antigenOther466Rapid Immunoassay Test Cassette288SureScreen DiagnosticsUnited Kingdomwww.surescreen.com/YesCommercialisedNoNoLateral flowNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:00375Immuno-AntibodyYesNoImmunoassayQualitative10FpEvaluatedFnEvaluatedAccuracy99.6% IgGAccuracy97.8% IgMClinical Sensitivity100% IgGClinical Sensitivity91.8% IgMClinical Specificity99.5% IgGClinical Specificity97.2% IgM1063Rapid COVID-19 IgM/IgG Combo Test Kit (Antibody)77Megna Health IncUnited Stateswww.megnahealth.comYesCommercialisedNoNoLateral flowNear POC / POCAntibodyIgGIgMACD plasmaSerumThe Megna Rapid COVID-19 IgM/IgG Combo Test Kit has been exhaustively tested - by Megna Health and by independent testing conducted by National Institute of Health and National Cancer Society - as required by FDA prior to issuing an Emergency Use Authorization letter on July 17, 2020.; https://www.megnahealth.com/wp-content/uploads/2020/07/MegnaHealth-Test-Kit_-IFU.pdf2021-05-10 13:04:0097Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15CalibrationEvaluatedCrossreactivityEvaluatedPrecisionEvaluatedRobustnessEvaluatedClinical Sensitivity100%Clinical Sensitivity83.3% IgMClinical Sensitivity100% IgGClinical Specificity95%Clinical Specificity97.5% IgMClinical Specificity97.5% IgM439Rapid 2019-nCoV IgG/IgM Combo Test Card277Xiamen Boson Biotech Co. LtdChinabosonbio.com/YesCommercialisedNoNoCardNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:00351Immuno-AntibodyYesNoImmunoassayQualitative15 1126Rapid 2019-nCoV IgG/IgM Combo Test367MP BiomedicalsUnited Stateswww.mpbio.com/YesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood with anti-coagulants https://www.mpbio.com/eu/2019-ncov-igg-igm-combo-test2021-05-10 13:04:00909Immuno-AntibodyYesNoImmunoassayQualitative10Crossreactivitynone for tested diseases; (HBsAb, TP antibody, HCV antibody, HIV antibody,Influenza Avirus antibody, Influenza Bvirus antibody, Respiratory syncytial virus antibody,Mycoplasmapneumoniae antibody, Chlamydia pneumonia antibody, Respiratory adenovirus antibPrecision100%Accuracy95.87%Clinical Sensitivity94.74%Clinical Sensitivity70.59% IgMClinical Sensitivity90.4% IgGClinical Specificity97.06%Clinical Specificity99.67% IgMClinical Specificity97.39% IgG1631727Tianjin New Bay Bioresearch CChinanot foundNoCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:04:001311Immuno-AntibodyYesNoImmunoassayQualitativeColloidal gold15CrossreactivityInfluenza A, Influenza B, Adenovirus, HBsAg, Syphilis, H.Pylori, HIV I, HIV II, HCV, TBFp10.6%Fn2.3%268QuickProfile 2019-nCoV IgG/IgM Combo Test Card167LumiQuick Diagnostics IncUnited Stateslumiquick.co/YesCommercialisedNoNoCardNear POC / POCAntibodyIgGIgM2021-05-10 13:04:00223Immuno-AntibodyYesImmunoassayQualitative15Type of antigenSpike and Nucleocapsid318PRIMA COVID-19 IgG/IgM Rapid Test (For Professional Use)808PRIMA LabSwitzerlandprimahometest.com/en/YesCommercialisedNoNoLateral flowNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:18:20266Immuno-AntibodyYesNoImmunoassayQualitative10Type of antigenNucleocapsid (N) antigen 307PCL COVID19 IgG/IgM Rapid Gold202PCL IncSouth Koreawww.pclchip.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgM2021-05-10 13:04:00259Immuno-AntibodyYesImmunoassay1003Pantest de Coronavirus IgM/IgG 2019-n-CoV599Pantest SAPolandwww.pantest.pt/YesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:00917Immuno-AntibodyYesNoImmunoassayQualitative20Precision98.6% IgGPrecision92.9% IgMClinical Sensitivity100% IgGClinical Sensitivity85% IgMClinical Specificity98% IgGClinical Specificity96% IgM474OZO Diamond - OZO SARS-CoV-2 IgM + IgG Method226OZO LifeUnited Kingdomwww.ozo.life/YesCommercialisedNoNoAutomatedManualAntibodyIgGIgMWhole blood2021-05-10 13:04:00289Immuno-AntibodyNoImmunoassayQualitativeNot found15Accuracy99.3%Type of antigenRecombinant SARS-CoV-2 antigens902OnSite COVID-19 IgG/IgM Rapid Test79CTK Biotech, IncUnited Stateswww.ctkbiotech.com/YesCommercialisedNoNoCassetteAutomatedManualAntibodyIgGIgMWhole blood2021-05-10 13:04:00857Immuno-AntibodyYesNoImmunoassayQualitativeNot found15Clinical Sensitivity98.2%Clinical Specificity97.8%535OnSite COVID-19 IgG/IgM79CTK Biotech, IncUnited Stateswww.ctkbiotech.com/NoCommercialisedNoNoCardNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:00459Immuno-AntibodyYesYesImmunoassayQualitative10Clinical Sensitivity96.9%Clinical Specificity99.4%190One Step Test for Novel Coronavirus(2019-nCoV) IgM/IgG antibody (Colloidal Gold)112Getein Biotech, IncChinaen.bio-gp.com.cn/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:00578Immuno-AntibodyYesImmunoassayQualitativeColloidal gold15Rapid diagnostic test cassette Colloidal Gold 1007One check 2019-nCoV IgG/IgM536Delta Chemie Biotechnology SASItalywww.deltachemie.it/?ln=enYesCommercialisedNoNoCardNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:00779Immuno-AntibodyYesNoImmunoassayQualitative20Rapid diagnostic test card CrossreactivityReportedAccuracy92.9%Clinical Sensitivity99.9%Clinical Specificity98%444Novel coronavirus(SARS-CoV-2) IgG/IgM Antibody Combined Test Kits285Yuno Diagnostics Co., LtdChinawww.yuno-diagnostics.com/YesCommercialisedNoNoCardLateral flowNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:04:00371Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15Clinical Sensitivity100%Clinical Specificity100%Type of antigennucleoprotein666Novel Coronavirus IgM/IgG Combo Rapid Test-Cassette551Beijing Decombio BiotechnologyChinawww.decombio-usa.com/NoCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:00801Immuno-AntibodyYesNoImmunoassayQualitativeNot found15Rapid diagnostic test cassette Not found 1686Novel Coronavirus COVID-19 IgM/IgG Test Kit757Biocomma limitedChinawww.biocomma.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:001365Immuno-AntibodyYesYesImmunoassayQualitativeColloidal gold15LOD312.5AUCalibrationevaluatedCrossreactivityevaluatedFp1.35%Fn0%PrecisionevaluatedAccuracy99.26% IgGAccuracy99.26% IgMReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity100% IgGClinical Sensitivity100% IgMType of antigennucleoprotein614Novel Coronavirus (SARS-CoV-2) Antibody (IgM / IgG) Test (Colloidal Gold)378Shanghai Outdo Biotech Co., LtdChinawww.superchip.com.cn/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgM2021-05-10 13:04:00523Immuno-AntibodyYesImmunoassayColloidal gold1640Novel Coronavirus (2019-nCoV) IgM/IgG Test Kit (Quantum Dots Immunofluorescence)735ISIAChinawww.isiabio.com/en/NoCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:001320Immuno-AntibodyYesYesImmunoassayQualitativeImmunofluorescence101639Novel Coronavirus (2019-nCoV) IgM/IgG Test Kit (Colloidal Gold Immunochromatography)735ISIAChinawww.isiabio.com/en/NoCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:001319Immuno-AntibodyYesYesImmunoassayQualitativeColloidal gold10452Novel Coronavirus (2019-nCoV) IgM/IgG Antibodies Detection Kit282Zhejiang Gene Science Co., LtdChinawww.digicell.cn/YesCommercialisedNoNoCardNear POC / POCAntibodyIgGIgMWhole blood   2021-05-10 13:04:00366Immuno-AntibodyYesNoImmunoassayQualitative786Novel Coronavirus (2019-nCoV) IgG/IgM Test Kit (Colloidal Gold)472Genrui Biotech IncChinawww.genrui-bio.com/YesCommercialisedNoNoLab-basedAntibodyIgGIgM2021-05-10 13:04:00653Immuno-AntibodyImmunoassay www.genrui-bio.com/products-detail.php?ProId=571345Novel Corona- virus IgM/IgG Combo Rapid Test653Shenzhen Highcreation Technology Co., LtdChinawww.hkrgr.com/YesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMPeripheral bloodPlasmaSerumWhole blood2021-05-10 13:04:001126Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15LOD0.1AUFp1%Fn1%Accuracy98.1% IgGAccuracy96.7% IgMClinical Sensitivity93% IgGClinical Sensitivity91.6% IgMType of antigennucleoprotein236Novel Corona Virus (SARS-CoV-2) IgM/IgG Rapid Test Kit145Jiangsu Bioperfectus Technologies Co. LtdChinawww.bioperfectus.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:04:00194Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry101393NOVACHECK Diagnostic kit (collodial gold) for IgG/IgM Antibody to SARS-CoV-2661NovatechTurkeywww.novadiag.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood https://www.novadiag.com/files/novadiag-katalog-english.pdf2021-05-10 13:04:001159Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15LOD0AUCalibrationNot evaluatedFp7.92%16 fake POSITIVE NUMBER OF PATIENTS / 202 TOTAL NUMBER OF PATIENTS) * 100: 7.92%Fn2.1%8 fake NEGATIVE NUMBER OF PATIENTS / 380 TOTAL NUMBER OF PATIENTS) *100: %2.10Accuracy95.88%95 CI:%93.44-%97.2Clinical Sensitivity92.08%95 CI:%87.52-%95.07Clinical Specificity97.89%Type of antigennucleoprotein865NG-Test IgG-IgM COVID-19572NG BiotechFrancengbiotech.com/YesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:00841Immuno-AntibodyYesNoImmunoassayQualitative151078nCOV IgG/IgM Rapid Test582Diagnostic Automation/Cortez Diagnostics, IncUnited Stateswww.rapidtest.comYesCommercialisedNoNoLateral flowNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:04:00858Immuno-AntibodyYesNoImmunoassayQualitative15CalibrationEvaluatedCrossreactivityEvaluatedPrecisionEvaluatedReproducibilityEvaluatedClinical Sensitivity91.9%1023nCoV IgG/IgM combo test245Shanghai Chemtron Biotech Co. LtdChinawww.chemtronbio.com/YesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMWhole blood https://www.technogenetics.it/en/news-events/the-covid-epidemic-in-italy-technogenetics-at-the-forefront2021-05-10 13:04:00937Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry10938Nano-Check COVID-9 IgG/IgM Antibody Test583Nano-Ditech CorporationUnited Stateswww.nanoditech.com/YesCommercialisedNoNoAutomatedManualAntibodyIgGIgMWhole blood2021-05-10 13:04:00859Immuno-AntibodyNoImmunoassayQualitativeChemiluminescence10CrossreactivityEvaluated289NADAL COVID-19 IgG/IgM Test (243003N-25 and 243001N-10)182Nal von minden GmbHGermanywww.nal-vonminden.com/YesCommercialisedNoNoLateral flowNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:00239Immuno-AntibodyYesNoImmunoassayQualitative10CalibrationNot EvaluatedCrossreactivityReported as possiblePrecisionNot EvaluatedRobustnessNot EvaluatedClinical Sensitivity94.1%Clinical Specificity98.2%584MP Rapid 2019-nCoV IgG/IgM367MP BiomedicalsUnited Stateswww.mpbio.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgM2021-05-10 13:04:00494Immuno-AntibodyYesImmunoassay1068MEDsan COVID-19 IgM/IgG Rapid Test Hybrid617MEDsan GmbHGermanywww.medsan.eu/en/YesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood https://www.medsan.eu/en/detection/2021-05-10 13:04:00995Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry101051MEDsan COVID-19 IgM/IgG Rapid Test621MPC International S.A.Germanywww.medsan.eu/en/YesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:04:00973Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry10CrossreactivityEvaluatedType of antigenNucleoprotein796MediKit Covid-19 Antibody Test (IgM/IgG Lateral flow Immunoassay)463MedikitIndiawww.medikitglobal.com/YesCommercialisedNoNoLateral flowNear POC / POCAntibodyIgGIgMWhole blood the kit's name is slighlty different 2021-05-10 13:04:00640Immuno-AntibodyYesNoImmunoassayQualitative15Clinical Sensitivity88.66%Clinical Specificity90.63%477LYHER Novel Coronavirus(2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold)302Hangzhou Laihe Biotech Co., LtdChinawww.lyherbio.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgM2021-05-10 13:04:00399Immuno-AntibodyYesImmunoassayColloidal gold258Leadgene SARS/SARS-CoV-2 IgG/IgM Rapid Test Kit157Leadgene Biomedical, IncTaiwan ROCwww.leadgenebio.com/NoIn developmentNoNoNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:00214Immuno-AntibodyYesNoImmunoassayQualitative151168Lab-On-Time 2019-nCoV IgG/IgM Rapid Test611BMT DiagnosticsIsraelwww.bmtdiagnostics.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerum2021-05-10 13:04:00945Immuno-AntibodyYesNoImmunoassayQualitative10Rapid diagnostic test Lateral Flow Accuracy94.9%Clinical Sensitivity94.4%71Kewei COVID-19 IgG/IgM antibody Rapid Test Kit (Colloidal Gold)43Beijing Kewei Clinical Diagnostic Reagent IncChinaen.keweidiagnostic.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:04:001240Immuno-AntibodyYesNoImmunoassayQualitativeColloidal gold10Accuracy96%Clinical Sensitivity93.3%Clinical Specificity98.2%1615INNOGEN-B™ COVID-19 IgM/IgG Rapid test717B-bio Co., Ltd.South Koreawww.b-bio.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:04:001295Immuno-AntibodyYesNoImmunoassayQualitativeN.A.15LOD1Calibrationnot evaluatedCrossreactivityevaluatedFpnot foundPrecisionevaluatedAccuracy97.9%ReproducibilityevaluatedRobustnessnot evaluatedClinical Sensitivity95.5%837Ichroma COVID-19 Ab, IgM/IgG22Boditech Med IncSouth Koreawww.boditech.co.kr/eng/YesCommercialisedNoNoCartridgeManualAntibodyIgGIgMWhole blood2021-05-10 13:04:00687Immuno-AntibodyYesYesImmunoassayQualitativeFluorescence10219Humasis COVID-19 IgG/IgM Test140HumasisSouth Koreawww.humasis.com/en/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgM2021-05-10 13:04:00180Immuno-AntibodyYesImmunoassay248Human Anti-SARS-CoV-2 (Covid-19) IgG/IgM Rapid Test153KRISHGEN BioSystemsUnited Stateswww.krishgen.com/YesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:00200Immuno-AntibodyYesNoImmunoassayQualitative15463Hightop SARS-CoV-2 IgM/IgG Antibody Rapid Test286Qingdao Hightop Biotech Co., LtdChinawww.hightopbio.com/YesCommercialisedNoNoLateral flowNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:00373Immuno-AntibodyYesNoImmunoassayQualitative10CrossreactivityReported as not possibleFpEvaluatedFnEvaluatedPrecisionNot EvaluatedAccuracy92.8% IgMAccuracy96% IgGReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity82% IgMClinical Sensitivity93% IgGClinical Specificity96% IgMClinical Specificity97% IgG1082GLINE-2019-nCoV IgM/IgG379SHENZHEN YHLO BIOTECH CO., LtdChinawww.szyhlo.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole bloodhttps://pdf.medicalexpo.com/pdf/shenzhen-yhlo-biotech-co-ltd/reagent-sars-cov-2-poct/107786-227353.html2021-05-10 13:04:001589Immuno-AntibodyNoImmunoassayQualitativeColorimetry15Clinical Sensitivity88.55% IgMClinical Sensitivity94.58% IgGClinical Sensitivity96.39%565GenSure COVID-19 IgG/IgM Rapid Test (REF: P2002)340GenSure Biotech IncChinawww.gensbio.com/YesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:00450Immuno-AntibodyYesNoImmunoassayQualitative15707Genonto RapidTest10 COVID-19 IgG/IgM Antibody Rapid Test Kit43Beijing Kewei Clinical Diagnostic Reagent IncChinaen.keweidiagnostic.com/NoCommercialisedNoNoNear POC / POCAntibodyIgGIgM Additional info: https://www.asiatechdaily.com/genbody-coronavirus-test-kit/ Not found in the company website2021-05-10 13:04:00589Immuno-AntibodyYesImmunoassayRapid diagnostic test Not found Not found 917GenomeCov9 IgM/IgG Rapid Test Kit504Applied Biological Materials IncCanadawww.abmgood.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:00743Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15Rapid diagnostic test Lateral flow Colloidal Gold PrecisionClinical Sensitivity91%Clinical Specificity99%850Genelogic COVID-19 IgM/IgG Antibody Test Kit484Genelogic Research LimitedHong Kong S.A.Rwww.genelogic.com.hk/YesCommercialisedNoNoFingertipAutomatedManualAntibodyIgGIgMWhole blood2021-05-10 13:04:00671Immuno-AntibodyYesNoImmunoassayQualitative15Clinical Sensitivity94.8%Clinical Specificity91.7%Type of antigenSARS-CoV-21145600Green Cross Medical Science Corp.South Koreawww.greencrossms.com/eng/main.do?lang=ENYesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:04:00922Immuno-AntibodyYesNoImmunoassayQualitative15Accuracy98%Clinical Sensitivity95.6%170GenBody FIA COVID-19 IgM/IgG97GenBody, IncSouth KoreaNoCommercialisedNoNoAutomatedManualAntibodyIgGIgM2021-05-10 13:04:00128Immuno-AntibodyImmunoassayManual or automated 169GenBody COVID-19 IgM/IgG97GenBody, IncSouth KoreaYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:00127Immuno-AntibodyYesNoImmunoassayQualitative15Rapid diagnostic test cassette CrossreactivityReportedAccuracy96.5%Clinical Sensitivity91.7%Clinical Specificity97.5%554GA CoV-2 IgG/IgM/IgG+351GA Generic Assays GmbHGermanywww.genericassays.comYesCommercialisedNoNoAutomatedManualAntibodyIgGIgMPlasmaSerum2021-05-10 13:04:00469Immuno-AntibodyNoYesELISAQualitativeFluorescence105Manual or automated Fluorescence Clinical Sensitivity98%Clinical Specificity98% 585FREND COVID-19 IgG/IgM Duo354NanoEntekSouth Koreawww.nanoentek.comYesCommercialisedNoNoAutomatedManualAntibodyIgGIgMPlasmaSerum2021-05-10 13:04:00478Immuno-AntibodyYesImmunoassayQuantitativeFluorescence3CrossreactivityEvaluatedFpEvaluatedFnEvaluatedClinical Sensitivity93%Clinical Specificity97%1211Finecare SARS-CoV-2 IgM/IgG Test124Guangzhou Wondfo Biotech Co., LtdChinaen.wondfo.com.cn/YesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgM2021-05-10 13:04:00994Immuno-AntibodyYesImmunoassay351EDR COVID 19 Rapid Test Kit (IgM/IgG)687Sensing Self Pte., LtdSingaporewww.sensingself.meYesCommercialisedNoNoLateral flowNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:18:20218Immuno-AntibodyYesNoImmunoassayQualitativeColorimetryCrossreactivityReported as not possibleAccuracy92.8% IgMAccuracy96.5% IgGClinical Sensitivity82% IgMClinical Sensitivity93% IgGClinical Specificity96% IgMClinical Specificity97% IgG662Edinburgh Genetics COVID-19 Colloidal Gold Immunoassay Testing Kit, IgG/IgM Combined88Edinburgh Genetics LimitedUnited Kingdomeggenetics.com/YesCommercialisedNoNoFingertipNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:00555Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry10Clinical Sensitivity98.43%Clinical Specificity99.31%991DyonCovid19 - SARS-CoV-2 IgM/IgG Antibody Rapid Test Device.529DyonMed SAGreecedyonmedical.com/en/home/YesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:00770Immuno-AntibodyYesNoImmunoassayQualitative15669DPP COVID-19 IgM/IgG System408Chembio Diagnostic SystemsUnited Stateswww.chembio.comNoCommercialisedNoNoLab-basedAntibodyIgGIgMWhole blood2021-05-10 13:04:00562Immuno-AntibodyYesImmunoassayQualitativeNot found15 Not found Not found 986DIAQUICK COVID-19 IgG/IgM Cassette Rapid Test526DIALAB GmbHAustriawww.dialab.at/en/home/YesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:00767Immuno-AntibodyYesNoImmunoassayQualitative10Type of antigennucleocapsid protein1055Diaquick Covid-19 IgG/IgM526DIALAB GmbHAustriawww.dialab.at/en/home/YesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:04:00982Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry10Clinical Sensitivity87.9% IgMClinical Sensitivity97% IgGClinical Specificity100%879Diagnostic Kit for IgM / IgG Antibody to Coronavirus (SARS-CoV-2) (Lateral Flow)225Zhuhai Livzon Diagnostics IncChinawww.livzondiagnostics.com/en-us/list/39.htmlYesCommercialisedNoNoLateral flowNear POC / POCAntibodyIgGIgMPlasmaSerumVenous whole blood2021-05-10 13:04:00287Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15Accuracy95.3%Clinical Sensitivity90.6%Clinical Specificity99.2%Type of antigennucleocapsid1582Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV-2661NovatechTurkeywww.novadiag.comYesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:18:201262Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15LOD95AUCalibrationevaluatedCrossreactivityevaluatedFp97%Fn98%PrecisionevaluatedAccuracy98.6% IgGAccuracy88.4% IgMReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity96.4% IgGClinical Sensitivity71.4% IgM440Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-COV-2862Xiamen Wiz Biotech Co., LtdChinawww.wizbiotech.comYesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:18:20705Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry151609Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV- 2704Genesprint Group LimitedHong Kong S.A.Rwww.gsprint.coYesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:04:001289Immuno-AntibodyYesNoImmunoassayQualitativeColloidal gold10LOD170CalibrationevaluatedCrossreactivityevaluatedFp1.64%Fn1.52%PrecisionevaluatedAccuracy87.06% IgGAccuracy86.57% IgMReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity87.06% IgGClinical Sensitivity86.57% IgM1634DABLOOD COVID-19 IgM/IgG Rapid Antibody Test730Dablood pharmaceuticalChinawww.dabloodpharmaceutical.comYesCommercialisedNoNoStripNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:04:001314Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15rapid diagnostic test strip colloidal gold Accuracy98%2055COVlD-19 IgM/IgG Antibodies Rapid Test(Colloidal GoId Method)946Beijing Bohui Innovation Biotechnology Co., Ltd.Chinahttp://www.bohui-tech.com/YesNoNoCardDipstickLab-basedAntibodyIgGIgMPlasmaSerumWhole bloodno2021-05-17 09:22:291735Immuno-AntibodyImmunochromatographyColloidal gold15LOD00CalibrationNot evaluatedCrossreactivityNot evaluatedFp0NoneFn0NonePrecisionNot evaluatedReproducibilityNot evaluatedRobustnessNot evaluatedClinical Sensitivity100% IgGClinical Sensitivity100% IgMClinical Specificity97.1% IgGClinical Specificity97.1% IgMType of antigenOther1066COVIDual COVID-19 IgM/IgG Rapid Test573Eternal Materials Co., LtdTaiwan ROCwww.eternal-group.com/Home/EngIndexYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:04:00844Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15CalibrationNot evaluatedCrossreactivityNot evaluatedPrecisionEvaluatedAccuracy98.76%ReproducibilityNot evaluatedRobustnessNot evaluatedClinical Sensitivity93.94%Clinical Specificity99.311452COVIDTECH One Step SARS-CoV-2 IgM/IgG Antibody Rapid Test286Qingdao Hightop Biotech Co., LtdChinawww.hightopbio.com/YesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:04:001201Immuno-AntibodyYesNoImmunoassayQualitative15LOD200IU/mlCalibrationNot evaluatedCrossreactivityevaluatedFp18% IgM54/300 Fp7% IgG21/300Fn4% IgM40/1000 Fn25% IgG25/100Precisionnot evaluatedAccuracy97%Reproducibilitynot evaluatedRobustnessevaluatedClinical Sensitivity92% IgMClinical Sensitivity96% IgGType of antigennucleoprotein686COVID19 IgG/IgM Rapid Test557PharmatechUnited Stateswww.phamatech.comNoCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:00811Immuno-AntibodyYesImmunoassayQualitative10CrossreactivityEvaluatedAccuracy92.9% IgMAccuracy98.6% IgGClinical Sensitivity85% IgMClinical Sensitivity100% IgGClinical Specificity96% IgMClinical Specificity98% IgG1835COVID-PRESTO837AAZ-LMBFrancewww.covid19aaz.comYesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-17 11:01:431514Immuno-AntibodyNoImmunochromatographyQualitativeMembrane-based11LOD1AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0%Fn0%PrecisionEvaluatedAccuracy100% IgGAccuracy100% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100% IgGClinical Sensitivity100% IgMClinical Specificity100% IgGClinical Specificity100% IgMType of antigenNucleoprotein933COVID-9 IgG/IgM Rapid Test Kit (Colloidal Gold)516JOYSBIO (Tianjin) Biotechnology Co., LtdChinaen.joysbio.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgM2021-05-10 13:04:00753Immuno-AntibodyYesImmunoassayColorimetry1069COVID-19-CHECK-1 test574VEDALABChinawww.vedalab.comYesCommercialisedNoNoLateral flowNear POC / POCAntibodyIgGIgMPlasmaSerumWhole bloodVariable Cut off setting in IgG to increase the diagnostic value in different prevalence situations https://www.vedalab.com/videos/performing-covid-19-check-1-test/2021-05-10 13:04:00845Immuno-AntibodyYesNoChromatographyQualitative10LOD0AUCrossreactivityEvaluatedFp3%CI 95% range: 91.06-99.61, using samples collected prior to September 2019Fn7%CI 95% range: 85.09-94.46 versus PCR methodAccuracy94.42% (IgM+IgG) (CI 95%[90.92-96.80])ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity60.87% IgMClinical Sensitivity91.3% IgGType of antigennucleoprotein983COVID-19 Test IgM/ IgG549Willi Fox GmbHSwitzerlandwillifox.com/YesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMWhole blood LIMITATIONS1. The contents of this kit are to be used for the qualitative detection of SARS-CoV-2 viral antigen from the nasopharyngeal swab.2. A negative test result may occur if the level of an antigen in a sample is below the detection limit of the test.3. According to CDC’s guidance, the COVID-19 antigen test has the best sensitivity from day 1 to day 5 after the onset of symptoms. Antigen levelsin specimens collected beyond 5-7 days of the onset of symptoms may drop below the limit of detection of the test.4. Failure to follow the Test Procedure and interpretations of Test Results may adversely affect test performance and/or invalidate the Test Results.5. Test Results must be evaluated in conjunction with other clinical data available to the physician.6. Negative test results do not rule out other potential non-SARS-CoV-2 viral infections. Negative results should be confirmed by molecular diagnosis ifCOVID-19 disease is suspected.7. Positive test results do not rule out co-infections with other pathogens.8. Monoclonal antibodies may fail to detect or detect with less sensitivity, SARS-CoV-2 viruses that have undergone minor amino acid changes in thetarget epitope region. 2021-05-10 13:04:00869Immuno-AntibodyYesNoImmunoassayQualitativeClinical Sensitivity93.7% IgMClinical Sensitivity98.8% IgGClinical Specificity99.1% IgMClinical Specificity98.7% IgGType of antigennucleoprotein762COVID-19 RAPID IgG/IgM test kit452Accuster Technologies Pvt LtdIndiawww.accuster.com/YesCommercialisedNoNoLateral flowNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:00618Immuno-AntibodyYesNoImmunoassayQualitative15Clinical Sensitivity98%Clinical Specificity97%870COVID-19 Rapid IgG/IgM Combined Antigen Assay Pre-screening Test Kit (Model ERCSS05401)687Sensing Self Pte., LtdSingaporewww.sensingself.meYesCommercialisedNoNoFingertipAutomatedManualAntibodyIgGIgMWhole blood2021-05-10 13:18:20711Immuno-AntibodyImmunoassay10603COVID-19 IgM/IgG Rapid Test Kit364Ring Biotechnology Co., LtdChinawww.ringbio.com/YesCommercialisedNoNoLateral flowNear POC / POCAntibodyIgGIgMPlasmaSerum2021-05-10 13:04:00490Immuno-AntibodyYesNoImmunoassayQualitative10CrossreactivityEvaluatedFpEvaluatedFnEvaluatedAccuracy95.12%Clinical Sensitivity85%Clinical Specificity98.39%1998COVID-19 IgM/IgG Rapid Test Kit915Shenzhen Dakewe Bio-engineering Co., Ltd.Chinawww.dakewe.comYesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood[Reagents and Materials Provided] COVID-19 IgM/IgG Rapid Test (20 each) Foil pouched test device containing one test strip which is encased in plastic device cassette, one pipette for blood transfer, and one piece of desiccants. Buffer Vial (1 each) The buffer vial contains 10ml phosphate buffered saline (PBS) for sample dilution. Package Insert (1 each) Instructions for use.2021-05-10 13:04:001675Immuno-AntibodyImmunochromatographyQualitative15LOD0AUCalibrationNot evaluatedCrossreactivityEvaluatedFp1.92%(7/364)Fn6.12%(15/245)PrecisionEvaluatedAccuracy96.4%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity93.9%Clinical Specificity98.1%Type of antigenOther276COVID-19 IgM/IgG Rapid Test Cassette449MedicalSystem Biotechnology Co., LtdChinaen.nbmedicalsystem.com/en/YesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:00647Immuno-AntibodyYesNoImmunoassayQualitative101027COVID-19 IgM/IgG Rapid Test (Colloidal Gold)612Well BiotechChinawww.wellbioscience.comYesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMWhole bloodhttp://www.wellbioscience.com/products/index/1u5858IP85x4R171.html2021-05-10 13:04:00946Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry10Accuracy98.5%Clinical Sensitivity97.1%Clinical Specificity100%1630COVID-19 IgM/IgG Rapid Test726WHPMUnited Stateswww.whpm.comYesCommercialisedNoNoCassetteFingertipNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:04:001310Immuno-AntibodyYesImmunoassayQualitative15Accuracy99.2%Clinical Sensitivity97.5%Clinical Specificity100%624COVID-19 IgM/IgG Lateral Flow Assay372Tianjin Era Biology Technology Co., LtdChinawww.era-bio.com/YesCommercialisedNoNoLateral flowNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:00514Immuno-AntibodyYesNoImmunoassayQualitative10132COVID-19 IgM/IgG Ab Test420Core Technology Co., LtdChinawww.coretests.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:00575Immuno-AntibodyYesNoImmunoassayQualitativeNot found15Rapid diagnostic test cassette Not found 90COVID-19 IgM-IgG Dual Antibody Rapid Test55BioMedomics, IncUnited Stateswww.biomedomics.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:0064Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry10Rapid diagnostic test Lateral flow Colloidal Gold CrossreactivityReported as not possibleClinical Sensitivity88.66%Clinical Specificity90.63%1001Covid-19 IgG/IgM test kit (Colloidal Gold Method)533Hangzhou Singclean Medical Products Co., LtdChinawww.singclean.net/YesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:04:00775Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15857COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma)131Hangzhou Testsea Biotechnology Co., LtdChinawww.testsealabs.com/YesCommercialisedNoNoAutomatedManualAntibodyIgGIgMWhole blood2021-05-10 13:04:00831Immuno-AntibodyYesNoImmunoassayQualitativeColloidal gold5Accuracy94%Clinical Sensitivity88%1475COVID-19 IgG/IgM Test Cassette659CITEST DIAGNOSTICS INCCanadawww.citestdiagnostics.com/YesCommercialisedNoNoCassetteLateral flowNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:04:001224Immuno-AntibodyYesYesImmunoassayQualitative15LOD0CalibrationevaluatedCrossreactivityevaluatedFp3.3%Fn3.1%PrecisionevaluatedAccuracy96.9%(IgG/IgM)ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity96.7%(IgG/IgM)651COVID-19 IgG/IgM Rapid Test Kit399Shenzhen Reagent Technology Co., LtdChinawww.reagen.cn/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgM2021-05-10 13:04:00548Immuno-AntibodyYesImmunoassay1382COVID-19 IgG/IgM Rapid Test Dipstick126Hangzhou AllTest Biotech Co., LtdChinawww.alltests.com.cn/YesCommercialisedNoNoDipstickNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood similar to 674 but name a bit different (on website same as 674: 2019-nCoV IgG/IgM Rapid Test Dipstick)2021-05-10 13:04:001148Immuno-AntibodyYesNoImmunoassayQualitative10LOD0AUFp2% IgGFp3% IgMFn0.1% IgGFn9.1% IgMAccuracy98.4% IgGAccuracy95.9% IgMClinical Sensitivity99.9% IgG99.9]]>Clinical Sensitivity90.9% IgM1694COVID-19 IgG/IgM Rapid Test Dipstick890Acro Biotech IncUnited Stateswww.acrobiotech.comYesCommercialisedNoNoDipstickNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:18:201373Immuno-AntibodyYesNoImmunoassayQualitative10LOD0AUCalibrationnot evaluatedCrossreactivityevaluatedFp2AU(IgG)Fp3AU(IgM)Fn0.1AU(IgG)Fn9.1AU(IgM)PrecisionevaluatedAccuracy98.4% IgGAccuracy95.9% IgMReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity99.9% IgGClinical Sensitivity90.9% IgM664COVID-19 IgG/IgM Rapid Test Device455Assure Tech. (Hangzhou) Co., LtdChinawww.diareagent.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:00799Immuno-AntibodyYesNoImmunoassayQualitativeNot found15Rapid diagnostic test cassette Not found 1912COVID-19 IgG/IgM Rapid Test Device871Azure Biotech IncUnited Stateswww.azure.bioYesCommercialisedNoNoManualNear POC / POCAntibodyIgGIgMPlasmaSerumWhole bloodNot available2021-05-10 13:04:001587Immuno-AntibodyImmunoassayQualitativeColorimetry15CrossreactivityEvaluatedPrecisionEvaluatedAccuracy98.7% IgGAccuracy97.7% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.7% IgMClinical Sensitivity98.8% IgGClinical Specificity99.1% IgMClinical Specificity98.7% IgGType of antigenOther212COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)128Hangzhou Biotest Biotech Co., LtdChinaen.biotests.com.cnYesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:04:00168Immuno-AntibodyYesNoImmunoassayQualitative15563COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)524Genitech NSAN Pharmaceutical Pvt. LtdIndiawww.linkedin.com/in/genitech-nsan-pharmaceutical-pvt-ltd-3739061a0/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:04:00763Immuno-AntibodyYesNoImmunoassayQualitative10Rapid diagnostic test cassette Not found Accuracy92.9%987COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)527Shanghai International Holding Corp. GmbH(Europe) (DE)Chinawww.cliawaived.comYesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:04:00768Immuno-AntibodyYesNoImmunoassayQualitative10Clinical Sensitivity90%677COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)554Healgen ScientificUnited Stateswww.healgen.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:00806Immuno-AntibodyYesNoImmunoassayQualitative101377COVID-19 IgG/IgM Rapid Test Cassette126Hangzhou AllTest Biotech Co., LtdChinawww.alltests.com.cn/YesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood similar to 208 (name a bit different but in website : 2019-nCoV IgG/IgM Rapid Test Cassette)2021-05-10 13:04:001142Immuno-AntibodyYesNoImmunoassayQualitative10Rapid diagnostic test lateral flow LOD0CalibrationNot evaluatedFp5%Fn5.6%Accuracy94.9%Clinical Sensitivity94.4%619COVID-19 IgG/IgM Rapid Test Cassette371Syrona LimitedUnited Kingdomwww.syronawomen.com/YesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMPlasmaSerum2021-05-10 13:04:00512Immuno-AntibodyYesImmunoassayQualitative10Type of antigenS1 subunit of the spike protein (S), Nucleocapid phosphoprotein (N)1829COVID-19 IgG/IgM Rapid Test Cassette835BIOLAN HEALTH, S.L.Spainwww.biolanhealth.comYesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMPlasmaSerumWhole bloodDetection of neutralizing antibodies. IgG and IgM antibodies against RBD of spike protein.2021-05-10 13:04:001507Immuno-AntibodyYesImmunoassay1970COVID-19 IgG/IgM Rapid Test Cassette887Chinasejoy.com/YesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood with anti-coagulantsWe have evulated the relative interference substances.2021-05-10 13:04:001646Immuno-AntibodyNoImmunoassayQualitativeSandwichOther15LOD40AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0% IgGFp2% IgMFn0AUFn9% IgMPrecisionEvaluatedAccuracy100% IgGAccuracy93.33% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100% IgGClinical Sensitivity88.61% IgMClinical Specificity100% IgGClinical Specificity97.67% IgMType of antigenOther465COVID-19 IgG/IgM Rapid Test Cassette890Acro Biotech IncUnited Stateswww.acrobiotech.comYesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:18:20712Immuno-AntibodyYesNoImmunoassayQualitativeColloidal gold10FpEvaluatedFnEvaluatedAccuracy98.6% IgGAccuracy92.9% IgMRobustnessEvaluatedClinical Sensitivity100% IgGClinical Sensitivity85% IgMClinical Specificity98% IgGClinical Specificity96% IgM464COVID-19 IgG/IgM Rapid Test Cassette912Biozek MedicalNetherlandswww.biozek.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:18:20374Immuno-AntibodyYesNoImmunoassayQualitative10Rapid diagnostic test Lateral flow FpReportedFnReportedAccuracy98.6% IgGAccuracy92.9% IgMRobustnessReportedClinical Sensitivity100% IgGClinical Sensitivity85% IgMClinical Specificity98% IgGClinical Specificity96% IgM1394COVID-19 IgG/IgM Rapid Test (Strip)659CITEST DIAGNOSTICS INCCanadawww.citestdiagnostics.com/YesCommercialisedNoNoStripNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:04:001160Immuno-AntibodyYesNoImmunoassayQualitative10Rapid diagnostic test Strip LOD0CalibrationNot evaluatedFp5%Fn5.6%Accuracy94.9%Clinical Sensitivity94.4%1479COVID-19 IgG/IgM Rapid Test (For Reader)659CITEST DIAGNOSTICS INCCanadawww.citestdiagnostics.com/YesCommercialisedNoNoLateral flowNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood no info in company website2021-05-10 13:04:001228Immuno-AntibodyYesYesImmunoassayQualitative10LOD0IU/mlCalibrationnot evaluatedCrossreactivityevaluatedFp5%Fn5.6%PrecisionevaluatedAccuracy94.9%(IgG/IgM)ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity94.9%94.4(IgG/IgM)1677COVID-19 IgG/IgM Rapid Test (For Reader)890Acro Biotech IncUnited Stateswww.acrobiotech.comYesCommercialisedNoNoLateral flowNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:18:201356Immuno-AntibodyYesYesImmunoassayQualitative10LOD0AUCalibrationnot evaluatedCrossreactivityevaluatedFp5.6AUFn5AUPrecisionevaluatedAccuracy94.9% (IgG/IgM)ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity94.4%18COVID-19 IgG/IgM Rapid Test (colloidal gold-based)14AIVD Biotech IncChinawww.aivdbiotech.cn/NoIn developmentNoNoNear POC / POCAntibodyIgGIgMWhole blood http://en.keweidiagnostic.com/uploadfile/2020/0702/20200702085141757.pdf 2021-05-10 13:04:00618COVID-19 IgG/IgM Rapid Test (colloidal gold-based)381Spring Healthcare Services AGSwitzerlandwww.springhealthcare.org/YesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMPlasmaSerum2021-05-10 13:04:00526Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry10FpEvaluatedFnEvaluatedAccuracy97%Clinical Sensitivity91%Clinical Specificity99%1389COVID-19 IgG/IgM Rapid Test (cassette)659CITEST DIAGNOSTICS INCCanadawww.citestdiagnostics.com/YesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:04:001155Immuno-AntibodyYesNoImmunoassayQualitative10Rapid diagnostic test lateral flow LOD0AUCalibrationNot evaluatedFp5%Fn5.6%Accuracy94.4%Clinical Sensitivity94.4%1381COVID-19 IgG/IgM Rapid Test126Hangzhou AllTest Biotech Co., LtdChinawww.alltests.com.cn/YesCommercialisedNoNoStripNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:04:001147Immuno-AntibodyYesNoImmunoassayQualitative10Rapid diagnostic test Strip LOD0Fp5%Fn5.6%Accuracy94.9%Clinical Sensitivity94.4%1321COVID-19 IgG/IgM Rapid Test410Monocent, IncUnited Stateswww.monocent.comYesCommercialisedNoNoCassetteAutomatedManualAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:04:001087Immuno-AntibodyNoImmunoassayQualitative15Fp0AUFn0AUAccuracy100%Clinical Sensitivity100%1031COVID-19 IgG/IgM Rapid Test542Zenum TechnologiesSwitzerlandwww.zenumtechnologies.com/YesCommercialisedNoNoLateral flowNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:00785Immuno-AntibodyYesNoImmunoassayQualitative15Clinical Sensitivity85% IgMIgM: 85 ; IgG: 99.9 Clinical Sensitivity99.9% IgGClinical Specificity96% IgMClinical Specificity98% IgG646COVID-19 IgG/IgM Rapid Test760Zhezhiang Orient Gene Biotech Co., LtdChinawww.orientgene.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerum2021-05-10 13:18:20532Immuno-AntibodyYesNoImmunoassayQualitative10Clinical Sensitivity87.9% IgGClinical Sensitivity97.2% IgMClinical Specificity100% IgGClinical Specificity100% IgM1012Covid-19 IgG/IgM Rapid Test912Biozek MedicalNetherlandswww.biozek.comYesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMWhole blood this website redirects to another company (Biozek); http://biozek.com/corona-virus-covid-rapid-test/2021-05-10 13:18:20780Immuno-AntibodyYesNoImmunoassayQualitative10Accuracy92.9%818COVID-19 IgG/IgM LF485Advagen Biotech LtdBrazilwww.advagen.com.br/NoCommercialisedNoNoLateral flowLab-basedAntibodyIgGIgM2021-05-10 13:04:00674Immuno-AntibodyImmunoassay672COVID-19 IgG/IgM ECO Teste552Eco Diagnostica LtdaBrazilecodiagnostica.com.br/NoCommercialisedNoNoCassetteLab-basedAntibodyIgGIgMWhole blood2021-05-10 13:04:00803Immuno-AntibodyYesImmunoassayQualitative15Clinical Sensitivity98.85%Clinical Specificity95%220COVID-19 IgG/IgM Detection Kit (Colloidal Gold)135Hunan Lituo Biotechnology Co., LtdChinawww.lituo.com.cn/en/YesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:04:00175Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry151155COVID-19 IgG/IgM Detection Kit (Colloidal Gold)604SINGUWAY BIOTECH IncChinawww.singuway.com/english/index.phpYesCommercialisedNoNoCardNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:04:00930Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry101186COVID-19 IgG/IgM Detection Kit (Colloidal Gold)619Zhuhai Lituo Biotechnology Co., LtdChinawww.lituo.com.cnYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:04:00967Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry10Accuracy96.9%Clinical Sensitivity93.8%Type of antigennucleocapsid antigen264COVID-19 IgG/IgM Combo Rapid Test Device160Liming Bio-Products Co., LtdChinawww.limingbio.com/YesCommercialisedNoNoStripNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:00219Immuno-AntibodyYesNoImmunoassayQualitative15Clinical Sensitivity82.2% IgGClinical Sensitivity64.7% IgMClinical Specificity100% IgGClinical Specificity100% IgM995COVID-19 IgG/IgM Combined Test kit(Colloidal Gold Method)533Hangzhou Singclean Medical Products Co., LtdChinawww.singclean.net/NoCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:18:20903Immuno-AntibodyYesNoImmunoassayQualitativeColloidal gold151632COVID-19 IgG/IgM Antibody Test(Colloidal Gold)131Hangzhou Testsea Biotechnology Co., LtdChinawww.testsealabs.com/YesCommercialisedNoNoCassetteLab-basedAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:18:201312Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15661COVID-19 IgG/IgM Antibody Test Cassette550NTBio Diagnostics IncCanadantbio.ca/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:00798Immuno-AntibodyYesNoImmunoassayQualitativeNot found15Accuracy97.2% IgGAccuracy87.9% IgM634Covid-19 IgG/IgM Antibody Rapid Test Kit376Wuhan UNscience Biotechnology Co., LtdChinawww.uni-science.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerum2021-05-10 13:04:00521Immuno-AntibodyYesNoImmunoassayQualitative10Clinical Sensitivity98.81%Clinical Specificity98.02%1932COVID-19 IgG/IgM Antibody Assay Kit(Colloidal Gold Method)884Surge Medical Inc.Netherlandswww.surge-on.nl/YesCommercialisedNoNoAntibodyIgGIgMNA2021-05-10 13:04:001608Immuno-AntibodyImmunoassayColloidal gold15LOD0.01AUCalibrationEvaluatedCrossreactivityEvaluatedFp2.04%(97.96)Fn3.04%(96.96)PrecisionEvaluatedAccuracy95.87%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.96%Clinical Specificity97.96%Type of antigenNucleoprotein776COVID-19 IgG/IgM Ab Rapid Test457Biogate Laboratories LtdCanadawww.biogatelab.com/index.htmlNoCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:00629Immuno-AntibodyYesNoImmunoassayQualitative15Rapid diagnostic test lateral flow CrossreactivityReportedAccuracy93.33% IgMAccuracy96.17% IgGClinical Sensitivity87.54% IgMClinical Sensitivity92.88% IgGClinical Specificity98.43% IgMClinical Specificity99.06% IgG1635COVID-19 IgG/IgM Ab Rapid Test731Invenio MedicalUnited Stateswww.invenio-medical.com/new-release/NoCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:04:001315Immuno-AntibodyYesNoImmunoassayQualitative15Accuracy98%1298COVID-19 IgG IgM Test624Zhejiang Anji Saianfu Biotech Co., LtdChinawww.seinofy.comYesCommercialisedNoNoLateral flowNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:04:001068Immuno-AntibodyYesNoImmunoassayQualitative10 LOD100AUAccuracy91%Clinical Sensitivity96.2% IgGClinical Sensitivity97.2% IgMType of antigennucleoprotein1697COVID-19 and M.pneumoniae IgG/IgM Combo Rapid Test890Acro Biotech IncUnited Stateswww.acrobiotech.comYesCommercialisedNoNoLateral flowNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:18:201376Immuno-AntibodyYesNoImmunoassayQualitative10LOD0AUCalibrationnot evaluatedCrossreactivityevaluatedFp2AU(IgG)Fp4AU(IgM)Fn0AU(IgG)Fn15AU(IgM)PrecisionevaluatedAccuracy98.6% IgG98.6 (COVID-Accuracy92.9% IgMReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity100% IgGClinical Sensitivity85% IgM1385COVID-19 and M.pneumoniae IgG/IgM Combo126Hangzhou AllTest Biotech Co., LtdChinawww.alltests.com.cn/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:04:001151Immuno-AntibodyYesNoImmunoassayQualitative10Rapid diagnostic test lateral flow LOD0AU0CalibrationNot evaluatedFp2% IgG+ M.pneumoniae IgG: 5.4%; M.pneumoniae IgM: 5.2%Fp4% IgMFn0% IgG+ M.pneumoniae IgG: 7.8%; M.pneumoniae IgM: 8.5%Fn15% IgMRobustnessNot evaluatedClinical Sensitivity100% IgG+92.2(Mycoplasma pneumoniae IgG); 91.5(Mycoplasma pneumoniae IgM)Clinical Sensitivity85% IgMClinical Specificity98.6% IgG+ 93.7(Mycoplasma pneumoniae IgG); 93.7(Mycoplasma pneumoniae IgM)Clinical Specificity92.9% IgM577COVID-19 (SARS-CoV-2) IgM/IgG Antibody Test Kit346Labnovation Technologies IncChinawww.labnovation.com/YesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMPlasmaSerum2021-05-10 13:04:00464Immuno-AntibodyYesNoImmunoassayQualitative20510COVID-19 (SARS-CoV-2) IgG/IgM Antibody Test Kit24Anhui Deep Blue Medical Technology Co., LtdChinawww.dbluemedical.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:00404Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15Rapid diagnostic test Strip Colloidal Gold 964Covid PRESTO Test rapide COVID-19 IgG/IgM519AAZFrancewww.covid19aaz.com/en/covid-19-aaz-2/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood https://drive.google.com/open?id=1IYwO5TKn5M0TnyOFlPDuq5de7x-HRT5V https://www.youtube.com/watch?v=ggugEocCscg; This company has reconverted its production (HIV tests) into COVID kits production2021-05-10 13:04:00865Immuno-AntibodyYesImmunoassayQualitativeNot found10Rapid diagnostic test cassette Not found 620383Tauschen Int. Ltd (Tauschen Groups)Hong Kong S.A.Rwww.tauschenhk.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgM https://www.testlinecd.com/file/1580/COVID-19_AN_NEW%20(002).pdf?version=202008131535 Additional info available only upon request2021-05-10 13:04:00528Immuno-AntibodyYesImmunoassayType of antigennucleocapsid recombinant antigen (NP)1086CoV-Check - COVID-19 IgG/IgM Test623Spark Diagnostics LLCIndiawww.sparkdiagnostics.comYesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood https://sparkdiagnostics.com/cov-check/2021-05-10 13:04:001011Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15CalibrationEvaluatedCrossreactivityEvaluatedPrecisionEvaluatedAccuracy94.74%IgG,IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity70.6% IgMClinical Sensitivity90.4% IgG543CORONAVÍRUS IgG/IgM (COVID-19)334Ebram Produtos Laboratoriais LtdBrazilwww.ebram.com/NoCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:00443Immuno-AntibodyYesNoImmunoassayQualitative20CrossreactivityReported Clinical Sensitivity99%Clinical Specificity98%2050Coronavirus Disease 2019 Antibody (IgM/IgG) Combined Test Kit944MedicalSystem Biotechnology Co. Ltd.Chinahttps://en.nbmedicalsystem.com/en/YesCommercialisedNoNoLateral flowLab-basedAntibodyIgGIgMOther biological fluidsPeripheral bloodPlasmaSalivaSerumSputumStoolThroat secretionThroat swabTissue homogenatesWhole bloodWhole blood with anti-coagulantsN.A.2021-05-10 13:04:001728Immuno-AntibodyNoImmunochromatographyQualitativeOther10LOD180AUCalibrationEvaluatedCrossreactivityEvaluatedFp8.23%Fn2.1%PrecisionEvaluatedAccuracy90% IgGAccuracy90% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.9% IgGClinical Sensitivity97.9% IgMClinical Specificity91.77% IgGClinical Specificity91.77% IgMType of antigenNucleoprotein1428Coronavirus COVID-19 lgM/IgG Test Kit (colloidal)655Guangdong Wesail Biotech Co., LtdChinaen.wesailbio.comYesCommercialisedNoNoCartridgeNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood http://en.wesailbio.com/product/82.html2021-05-10 13:04:001187Immuno-AntibodyYesNoImmunoassayQualitativeColloidal gold6Accuracy97.93%Clinical Sensitivity92.86%Clinical Specificity99%1440Coronavirus COVID-19 IgM/IgG Test Kit655Guangdong Wesail Biotech Co., LtdChinaen.wesailbio.comYesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:04:001191Immuno-AntibodyYesNoImmunoassayQualitativeColloidal gold6LOD3.125CalibrationNot evaluatedCrossreactivitynot evaluatedPrecisionnot evaluatedAccuracy93%Reproducibilitynot evaluatedRobustnessnot evaluatedClinical Sensitivity93%1933Coronavirus (SARS-CoV-2) Neutralizing Antibodies885Tody Laboratories Int.Romaniawww.todylaboratories.com/YesNoNoCassetteFingertipManualOtherAntibodyIgGIgMPeripheral bloodPlasmaSerumWhole bloodAnti-Spike Protein, Colloidal Gold2021-05-10 13:04:001609Immuno-AntibodyNoImmunochromatographyQualitativeNeutralization Antibody (NAb)N.A.10LOD0.025AUCalibrationEvaluatedCrossreactivityEvaluatedFpFrom studies performed by manufacturer, the false positive rate is 0% (specificity = 100%)FnFrom studies performed by manufacturer, the false negative rate is 0% (sensitivity = 100%)PrecisionEvaluatedAccuracy97.9%ReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity95.7%Clinical Specificity100%Type of antigenOther337Coronavirus (SARS-CoV-2) IgM/IgG Test Kit (Colloidal Gold)154RayBiotechUnited Stateswww.raybiotech.com/YesCommercialisedNoNoLateral flowNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:00205Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry10Accuracy97.41%Clinical Sensitivity90.44%Clinical Specificity98.31%1936Coronavirus (SARS-CoV 2) Ab IgG / IgM - Nucleocapsid (N protein)885Tody Laboratories Int.Romaniawww.todylaboratories.com/YesCommercialisedNoNoCassetteManualAntibodyIgGIgMPeripheral bloodPlasmaSerumWhole bloodNucleocapsid (N) protein as target. IgG Limit of Detection (LoD): 1:40 (0.025) IgM Limit of Detection (LoD): 1:8 (0.125)2021-05-10 13:04:001612Immuno-AntibodyNoImmunochromatographyQualitativeMembrane-basedN.A.10LOD0.025AUCalibrationEvaluatedCrossreactivityEvaluatedFp3.7%From studies performed by manufacturer, the false positive rate is 3.7% (specificity = 96.3%)Fn3.1%From studies performed by manufacturer, the false negative rate is 3.1% (sensitivity = 96.9%)PrecisionEvaluatedAccuracy96.4%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.9%Clinical Specificity96.3%Type of antigenNucleocapsid (N protein)1337Corona Virus Disease-19(COVID-19)IgG/IgM Rapid649TBG BIOTECHNOLOGY XIAMEN IncChinawww.tbgxm.comYesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:04:001109Immuno-AntibodyYesImmunoassayQualitativeColorimetry151930Corona Virus (COVID-19) Combined (IgM/IgG/Neutralizing antibody) Rapid Test (Colloidal gold)883Hoyotek Biomedical Co.,LtdChinahoyotek.cn/index.htmlYesCommercialisedNoNoCardManualAntibodyIgGIgMWhole bloodThis kit consists of test card 1 and test card 2. Test card 1 adopts the principle of colloidal gold immunochromatographic sandwich method to detect the novel Corona Virus (COVID-19) IgM / IgG antibody. When a positive sample is added to the sample well，COVID-19 Antibodies (IgM/IgG) in the sample will be combined with colloidal gold labeled COVID-19 RBD recombinant protein and form into immune complexes。When reaching Test Zone, the complexes will be combined with mouse anti-human IgM monoclonal antibody and mouse anti-human IgG monoclonal antibody. M line and G line occur red color. When testing negative samples, there’s no COVID-19 IgM or IgG in the samples, no immune complexes will be formed and color only appears in the Control line. Test card 2 adopts the principle of colloidal gold immunochromatographic competition method to detect Neutralizing antibody. When testing negative samples, colloidal gold labeled ACE2 protein will be combined with COVID-19 RBD recombinant protein which coated on test line and the detection line develops color. When a positive sample is added to the sample well, COVID-19 Neutralizing antibody in the sample mix with colloidal gold labeled ACE2 protein, and does not bind to COVID-19 RBD recombinant protein. The intensity of T line color is) less than C line.2021-05-10 13:04:001606Immuno-AntibodyNoImmunoassayQualitativeCaptureColloidal goldOther15Neutralizing antibodyLOD0.5AUCalibrationNot evaluatedCrossreactivityEvaluatedFp3%Fn1%PrecisionEvaluatedAccuracy98%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity99%Clinical Specificity97%Type of antigenOther1074Cormay Rapid SARS-CoV-2 IgG/IgM Ab579CORMAYPolandcormay.pl/index.php?lang=_enYesCommercialisedNoNoLateral flowNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:04:00852Immuno-AntibodyYesNoChromatographyQualitative10Accuracy97.72% IgMAccuracy98.52% IgGClinical Sensitivity96.52% IgGClinical Sensitivity94.07% IgM199Combined Detection Kit for Novel Coronavirus (2019-nCoV) IgM/IgG Antibody118Guangzhou Fenghua Bioengineering , Co. LTDChinawww.bio-fenghua.com/en/index.aspNoCommercialisedNoNoNear POC / POCAntibodyIgGIgM2021-05-10 13:04:00156Immuno-AntibodyYesImmunoassay 3424Anhui Deep Blue Medical Technology Co., LtdChinawww.dbluemedical.com/NoCommercialisedNoNoStripNear POC / POCAntibodyIgGIgM2021-05-10 13:04:0028Immuno-AntibodyYesImmunoassayColloidal goldRapid diagnostic test 675Clungene COVID-19 IgM/IgG Rapid Test Cassette413Hangzhou Clongene Biotech Co., LtdChinaen.clongene.com/YesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgM Product information is being updated...2021-05-10 13:04:00568Immuno-AntibodyYesImmunoassay1098CHiL COVID-19 IgG/IgM Rapid Test cassette589CHIL Medical Supplies LtdTurkeywww.chil.com.tr/YesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgM2021-05-10 13:04:00879Immuno-AntibodyYesNoImmunoassayQualitative10CalibrationPerformed (QCRSARSCoV-2QC1 - Anti-SARS-CoV-2 Quality Control 1 NIBSC code: 20/B764 is used)Crossreactivity0% (anti-influenza A (IgG), anti-influenza B (IgG), anti-HCV (IgG and IgM), anti-HBV (IgG and IgM), anti-229E (alpha coronavirus), anti-NL63 (alpha coronavirus), anti-OC43 (beta coronavirus), anti-HKU1 (beta coronavirus) , anti-respiratory syncytial viruFp0.1% IgGFp0.8% IgMFn0.5% IgGFn8% IgMPrecision100%Accuracy99.7% IgGAccuracy98% IgMReproducibility100%Robustness99%Clinical Sensitivity100% IgGClinical Sensitivity92% IgM1303Chexel COVID-19 IgM/IgG645NB POSTECHSouth Koreawww.nbpostech.comYesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:04:001074Immuno-AntibodyYesNoImmunoassayQualitative15Clinical Sensitivity75% IgGClinical Sensitivity96.8% IgM1613ChekR™ COVID-19 IgM/IgG Rapid test717B-bio Co., Ltd.South Koreawww.b-bio.comYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:04:001293Immuno-AntibodyYesNoImmunoassayQualitative15LOD0Calibrationnot evaluatedCrossreactivityevaluatedFpnot foundFnnot foundPrecisionevaluatedAccuracy97.9%ReproducibilityevaluatedRobustnessnot evaluatedClinical Sensitivity95.5%116Cellex qSARS-CoV-2 IgGIgM Cassette Rapid Test416Cellex IncUnited Statescellex.us/YesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:00571Immuno-AntibodyYesNoImmunoassayQualitativeNot found15Rapid diagnostic test cassette Not found Clinical Sensitivity93.75%Clinical Specificity96.4%506CareStart COVID-19 IgM/IgG321Access Bio, IncUnited Stateswww.accessbio.net/NoCommercialisedNoNoNear POC / POCAntibodyIgGIgM2021-05-10 13:04:00425Immuno-AntibodyYesImmunoassayRapid diagnostic test Not found Not found 1601Biomerica COVID-19 IgG/IgM Rapid Test (1507A)708Biomerica, Inc.United Statesbiomerica.com/index.aspYesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood data available upon request (LOD=0) 2021-05-10 13:04:001282Immuno-AntibodyYesNoImmunoassayQualitative10Rapid diagnostic test lateral flow LOD0AUCalibrationevaluatedCrossreactivityevaluatedFp4AUFn0AUPrecisionevaluatedAccuracy96%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity100%Type of antigennucleoprotein1603Biomerica COVID-19 IgG/IgM Rapid Strip Test (1507B)708Biomerica, Inc.United Statesbiomerica.com/index.aspYesCommercialisedNoNoStripNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood data available upon request2021-05-10 13:04:001284Immuno-AntibodyYesNoImmunoassayQualitative10LOD0AUCalibrationevaluatedCrossreactivityevaluatedFp10AUFn2AUPrecisionevaluatedAccuracy96.6%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity96.9%Type of antigennucleoprotein1716BIOCREDIT COVID-19 IgG/IgM Combo220RapiGEN IncSouth Korearapigen-inc.comYesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgM2021-05-10 13:18:201396Immuno-AntibodyYesNoImmunoassayQualitative15LOD0AUCalibrationevaluatedCrossreactivityevaluatedFp2.67%4/150Fn0%0/52PrecisionevaluatedAccuracy98%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity100%336BIOCREDIT COVID-19 IgG+IgM Duo220RapiGEN IncSouth Korearapigen-inc.comYesCommercialisedNoNoStripNear POC / POCAntibodyIgGIgMWhole blood these are two separated strips2021-05-10 13:04:00282Immuno-AntibodyYesNoImmunoassayQualitative101032BasePoint Covid-19 IgG/IgM Rapid test Device6AbbottUnited Stateswww.abbott.com/NoCommercialisedNoNoNear POC / POCAntibodyIgGIgM2021-05-10 13:04:00825Immuno-AntibodyYesImmunoassay515Atlas COVID-19 IgG/IgM Test Cassette314Atlas MedicalUnited Kingdomatlas-medical.com/YesCommercialisedNoNoLateral flowNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:00415Immuno-AntibodyYesNoImmunoassayQualitative10937ASSURE SARS-CoV-2 IgG/IgM Rapid Test367MP BiomedicalsUnited Stateswww.mpbio.com/YesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood with anti-coagulants2021-05-10 13:04:00737Immuno-AntibodyYesNoImmunoassayQualitative15CrossreactivityEvaluatedAccuracy99.43%Clinical Sensitivity100%Clinical Specificity99.41%1729Artron COVID-19 IgM/IgG Antibody Test721Artron Laboratories IncCanadawww.artronlab.comYesCommercialisedNoNoN.A.AutomatedManualNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:18:201409Immuno-AntibodyNoImmunoassayQualitative30Manual or automated lateral flow LOD0AUCalibrationevaluatedCrossreactivityevaluatedFp1.72% IgMcombined data from 6 centersFp0.22% IgGcombined data from 6 centersFn14.83% IgMcombined data from 6 centersFn6.01% IgGcombined data from 6 centersPrecisionevaluatedAccuracy93.64% IgMcombined data from 6 centersAccuracy94.2% IgGcombined data from 6 centersReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity85.17% IgMcombined data from 6 centersClinical Sensitivity83.99% IgGcombined data from 6 centers1410Immuno-AntibodyYesNoImmunoassayQualitative15rapid diagnostic test lateral flow LOD0Calibrationnot evaluatedCrossreactivityevaluatedFp1.87%26 false positives out of a total of 1393 RT-PCR confirmed non-COVID-19 specimensFn7.7%59 false negatives out of a total of 762 RT-PCR confirmed COVID-19 specimensPrecisionevaluatedAccuracy96.06 (IgG+IgM)ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity97.49 (IgG+IgM) 14 days post infection1731Antibody kit igg igm testing767Silversite diagnostics.corpUnited StatesWww.adam.comYesCommercialisedNoNoLateral flowNear POC / POCAntibodyIgGIgMSerum2021-05-10 13:04:001411Immuno-AntibodyNoImmunoassayQualitative15LOD100AUCalibrationevaluatedCrossreactivityevaluatedFp0%Fn0%PrecisionevaluatedAccuracy100%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity99.9%Type of antigennucleoprotein11Anti-SARS-CoV-2 nucleocapsid protein human IgM/IgG rapid detection kit9Academia SinicaTaiwan ROCwww.sinica.edu.tw/enNoIn developmentNoNoNear POC / POCAntibodyIgGIgM2021-05-10 13:04:0011Immuno-AntibodyYesImmunoassayRapid diagnostic test Type of antigenNucleocapside1172Anti-COVID-19 virus IgM/IgG Test Kit (lateral flow assay)616South Koreawww.hzlifescience.comYesCommercialisedNoNoLateral flowNear POC / POCAntibodyIgGIgMOtherSerumWhole blood2021-05-10 13:04:00953Immuno-AntibodyYesImmunoassayQualitative10404Anti-COVID-19 virus IgM/IgG rapid test kit (Colloidal gold assay)326Tianjin MNCHIP Technologies Co., LtdChinaen.mnchip.com/en/YesCommercialisedNoNoCardNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:04:00433Immuno-AntibodyYesImmunoassayQualitativeColorimetry15Accuracy100%Type of antigen N and S virus proteins993AMP Rapid Test SARS-CoV-2 IgG/IgM531AMEDA Labordiagnostik GmbHAustriawww.amp-med.com/YesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:001551Immuno-AntibodyImmunoassay830Amela Covid-19 IgM IgG Combo test kit478Amedica SANetherlandswww.amedicagroup.com/YesCommercialisedNoNoAutomatedManualAntibodyIgGIgMWhole blood Name from the website is "Rapid SARS-CoV-2 Antibody (IgM/IgG) Test"2021-05-10 13:04:00830Immuno-AntibodyNoImmunoassayQualitativeColorimetryManual or automated cassette Colloidal Gold 900AlphaBiolabs IgM-IgG Combined Antibody Rapid Test581AlphaBiolabsUnited Kingdomwww.alphabiolabs.co.ukYesCommercialisedNoNoCassetteAutomatedManualAntibodyIgGIgMWhole blood2021-05-10 13:04:00856Immuno-AntibodyNoImmunoassayQualitative15Type of antigenNucleocapsid (N) antigen836AFIAS COVID-19 Ab, IgM/IgG22Boditech Med IncSouth Koreawww.boditech.co.kr/eng/YesCommercialisedNoNoFingertipAutomatedAntibodyIgGIgMWhole blood2021-05-10 13:04:00686Immuno-AntibodyYesImmunoassayQualitativeFluorescence10994Acro 2019-nCoV IgG/IgM pikatesti594AIDIANFinlandwww.aidian.eu/YesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:00902Immuno-AntibodyYesNoImmunoassayQualitative20671AccuRapid SARS-CoV-2 IgM/IgG Test Kit (Lateral Flow Immunoassay)391Eachy BiopharmaceuticalsChinawww.eachybiopharma.comNoCommercialisedNoNoLateral flowNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:00539Immuno-AntibodyYesNoImmunoassayQualitative5Rapid diagnostic test Lateral flow 1984909Absology Co., Ltd.South Koreawww.absology.co.krNoIn developmentNoNoCartridgeLateral flowNear POC / POCSemi-automatedAntibodyIgGIgMSerum2021-05-10 13:04:001660Immuno-AntibodyYesImmunoassaySemiquantitativeNeutralization Antibody (NAb)Fluorescence10LOD20AUCalibrationEvaluatedCrossreactivityEvaluatedFpEvaluation ongoingFnEvaluation ongoingPrecisionEvaluatedAccuracy95%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96%Clinical Specificity98%Type of antigenOther1151Absoludy COVID-19 IgM/IgG Rapid601Absology Co., LtdSouth Koreawww.absology.co.kr/YesCommercialisedNoNoLateral flowNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood other website http://www.absology.co.kr/2021-05-10 13:04:00923Immuno-AntibodyYesNoImmunoassayQualitativeMagnetic Electrochemical15Accuracy95%Clinical Sensitivity90.24%Clinical Specificity97.82%1302Absoludy COVID-19 IgM/IgG Combo601Absology Co., LtdSouth Koreawww.absology.co.kr/YesCommercialisedNoNoLateral flowAutomatedLab-basedNear POC / POCAntibodyIgGIgMPlasmaSerum2021-05-10 13:04:001072Immuno-AntibodyYesImmunoassayQualitative10Analitical Specificity96% IgGAnalitical Specificity97% IgGAccuracy93.48%Clinical Sensitivity91.67%Type of antigenNucleoprotein913abia SARS-CoV- IgG/IgM320AB Dianostic Systems GmbHGermanywww.ab-ds.de/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMPlasmaSerum2021-05-10 13:04:00739Immuno-AntibodyNoYesImmunoassayQualitativeFluorescence120Clinical Sensitivity100%Clinical Specificity95.31%1004535Italywww.aebrapidtest.com/YesCommercialisedNoNoCassetteLateral flowNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:04:00777Immuno-AntibodyNoImmunoassayQualitative10Accuracy99.6% IgGAccuracy97.8% IgMAccuracy98.2%IgG+IgMClinical Sensitivity94.1%IgG+IgMClinical Sensitivity100% IgGClinical Sensitivity91.8% IgMClinical Specificity99.2%IgG+IgMClinical Specificity99.5% IgGClinical Specificity99.2% IgM1645A Rapid IgM-IgG Combined Antibody Test Kit for SARS-Cov-2-(ICA)753Jiangsu Mole Bioscience CO., LTDChinaen.molechina.com/YesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 14:15:281326Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15LOD0.1AUCalibrationevaluatedCrossreactivityevaluatedFp2.1%Fn1.6%PrecisionevaluatedAccuracy98% IgGAccuracy98% IgMReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity97.96% IgGClinical Sensitivity97.98% IgM1680A Rapid IgM-IgG Combined Antibody Test Kit for SARS-Cov-2 (ICA)753Jiangsu Mole Bioscience CO., LTDChinaen.molechina.com/YesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:04:001359Immuno-AntibodyYesNoImmunoassayQualitative15LOD5AUCalibrationevaluatedCrossreactivityevaluatedFp2.1%Fn1.6%PrecisionevaluatedAccuracy98% IgGAccuracy98% IgMReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity97.96% IgGClinical Sensitivity97.98% IgM10022019nCoV IgG/IgM Rapid test Device534AkralabSpainwww.akralab.es/YesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMWhole blood http://en.keweidiagnostic.com/uploadfile/2020/0721/20200721032246798.pdf 2021-05-10 13:04:00776Immuno-AntibodyYesNoImmunoassayQualitative15Type of antigennucleocapsid protein from SARS-CoV-2 COVID-1913592019-New Coronavirus IgM/IgG Rapid Test Cassette (WB/S/P)35Beijing Beier Bioengineering Co., LtdChinawww.mediport.comYesCommercialisedNoNoCassetteManualAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:04:001130Immuno-AntibodyYesYesImmunoassayQualitativeColorimetry15Manual NAT cassette colloidal gold LOD131FpRequire clinical data comparisonFnRequire clinical data comparisonAccuracy96.77%Clinical Sensitivity94.12% IgMClinical Sensitivity95.1% IgG1022539Neo Nostics (Suzhou) Bioingeneering Co. LTDChinawww.neo-nostics.com/en/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:00782Immuno-AntibodyYesNoImmunoassayQualitative10942019-nCoV IgMIgG Antibody Test Kit POCT Immunoassay System - HP-083/4587Shijiazhuang Hipro Biotechnology Co.,LtdChinawww.hipro.usYesCommercialisedNoNoFingertipNear POC / POCAntibodyIgGIgMPlasmaSerumhttp://www.hiprochina.com/html/View_3128.html2021-05-10 13:04:00874Immuno-AntibodyYesNephelometryQuantitative610952019-nCoV IgMIgG Antibody Test Kit (Nephelometry immunoassay method) Automatic ImmunoAssay System - HP-AFS/1587Shijiazhuang Hipro Biotechnology Co.,LtdChinawww.hipro.usYesCommercialisedNoNoFingertipNear POC / POCAntibodyIgGIgMPlasmaSerumhttp://www.hiprochina.com/html/View_3128.html2021-05-10 13:04:00875Immuno-AntibodyYesNephelometryQuantitative7Type of antigennucleocapsid (N) and spike (S) proteins (including the S1 RBD antigen)18072019-nCoV IgM/IgG Antibody Test Kit (colloidal gold method)779Guangdong Hecin Scientific, Inc.Chinawww.hecin-scientific.cn/YesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgM/2021-05-10 13:04:001484Immuno-AntibodyYesImmunoassayQualitativeColloidal gold15LOD1AUCalibrationEvaluatedCrossreactivityEvaluatedFp2AUFn3AUPrecisionEvaluatedAccuracy98.02%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.17%Clinical Specificity98.63%14882019-nCoV IgM/IgG Antibody Test Kit (colloidal gold method)848Bioteke Taizhou Biotechnology Co., LtdChinawww.bioteke.cn/YesCommercialisedNoNoAutomatedManualAntibodyIgGIgMPlasmaSerum2021-05-10 13:18:201231Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15LOD176AUCalibrationevaluatedCrossreactivityevaluatedFp1 for serum specimens, 2 for plasma specimensFn5 for serum specimens, 4 for plasma specimensPrecisionevaluatedAccuracy98.35%serum specimensAccuracy98.3%plasma specimensReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity95.1%serum specimensClinical Sensitivity95.92%plasma specimensType of antigennucleoprotein5702019-nCOV IgG/LgM Rapid Test Device344Hangzhou Realy Tech Co., LtdChinawww.realytech.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:00458Immuno-AntibodyYesNoImmunoassayQualitativeRapid diagnostic test cassette 8682019-nCOV IgG/IgM Test Cassette (Whole blood/Serum/Plasma)487Prometheus Bio IncChinawww.prometheusbio.com/YesCommercialisedNoNoCassetteAutomatedManualAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:04:00683Immuno-AntibodyNoImmunoassayQualitative10Clinical Sensitivity88.9%Clinical Specificity94%4892019-ncoV IgG/IgM Test508U2USystems (India) Pvt. LtdSingaporewww.u2uhealth.com/YesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:00732Immuno-AntibodyYesNoImmunoassayQualitative107662019-nCoV IgG/IgM Rapid Testing Kit412VazymeChinawww.vazymebiotech.com/YesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMPlasmaSerum2021-05-10 13:04:00621Immuno-AntibodyYesNoImmunoassayQualitative10 RobustnessEvaluatedClinical Sensitivity91.54%Clinical Specificity97.02%Type of antigennucleoprotein10352019-nCoV IgG/IgM Rapid Test Device546Safecare Biotech (Hangzhou) Co. LtdChinaen.safecare.com.cn/YesCommercialisedNoNoLateral flowNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:00793Immuno-AntibodyYesImmunoassayQualitative15Accuracy90.2%882019-nCoV IgG/IgM Rapid Test Cassette52BIOMAXIMA S.A.Polandwww.biomaxima.com/YesCommercialisedNoNoCassetteLateral flowNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:0060Immuno-AntibodyYesNoImmunoassayQualitative10CrossreactivityReportedClinical Sensitivity100% IgGClinical Sensitivity85% IgMClinical Specificity98% IgGClinical Specificity96% IgM2082019-nCoV IgG/IgM Rapid Test Cassette126Hangzhou AllTest Biotech Co., LtdChinawww.alltests.com.cn/YesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:00165Immuno-AntibodyYesImmunoassayQualitative13902019-nCoV IgG/IgM Rapid Test Cassette659CITEST DIAGNOSTICS INCCanadawww.citestdiagnostics.com/YesCommercialisedNoNoCassetteLateral flowNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:04:001156Immuno-AntibodyYesNoImmunoassayQualitative10LOD0CalibrationNot evaluatedFp3.7%Fn3.1%Accuracy96.4%Clinical Sensitivity96.9%16962019-nCoV IgG/IgM Rapid Test Cassette890Acro Biotech IncUnited Stateswww.acrobiotech.comYesCommercialisedNoNoCassetteLateral flowNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:18:201375Immuno-AntibodyYesNoImmunoassayQualitative10LOD0AUCalibrationnot evaluatedCrossreactivityevaluatedFp2% IgGFp4% IgMFp3.7%IgG, IgMFn15% IgMFn0% IgGFn3.1%IgG, IgMPrecisionevaluatedAccuracy92.9% IgMAccuracy96.4%IgG, IgMAccuracy98.6% IgGReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity100% IgGClinical Sensitivity85% IgMClinical Sensitivity96.9%IgG, IgM5682019-nCoV IgG/IgM Rapid Test413Hangzhou Clongene Biotech Co., LtdChinaen.clongene.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:00778Immuno-AntibodyYesImmunoassayQualitative10702019-nCoV IgG/IgM Rapid Test575Prestige DiagnosticsUnited Kingdomwww.prestigediagnostics.co.ukYesCommercialisedNoNoLateral flowNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:04:00846Immuno-AntibodyYesNoImmunochromatographyQualitative10LOD0AU0CalibrationEvaluatedCrossreactivityEvaluatedPrecisionEvaluatedAccuracy95% IgGAccuracy96.7% IgMReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity91.8% IgGClinical Sensitivity95.7% IgMClinical Specificity96.4% IgGClinical Specificity97.3% IgM10482019-nCoV IgG/IgM Device561AMS UK (NI) LtdUnited Kingdomwww.amslabs.co.ukYesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:04:00819Immuno-AntibodyYesNoImmunoassayQualitative10CrossreactivityEvaluatedPrecisionEvaluatedAccuracy95% IgGAccuracy96.7% IgMClinical Sensitivity91.8% IgGClinical Sensitivity95.7% IgMClinical Specificity96.4% IgGClinical Specificity97.3% IgM9602019-nCoV IgG/IgM Antibody Rapid Test Kit38Beijing Diagreat Biotechnologies Co., LtdChinawww.diagreat.com/YesCommercialisedNoNoAutomatedManualAntibodyIgGIgMWhole blood2021-05-10 13:04:00864Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15Manual or automated cassette Colloidal Gold CrossreactivityReported4972019-nCoV IgG/IgM Antibody Detection Kit316BiolidicsSingaporewww.biolidics.com/YesCommercialisedNoNoStripNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:00418Immuno-AntibodyYesNoImmunoassayQualitativeColloidal gold10Accuracy95%Clinical Sensitivity91.54%Clinical Specificity97.02%9592019-nCoV IgG / IgM Detection Kit (Colloidal Gold-Based)790Xiamen AmonMed Biotechnology Co., LtdChinawww.amonmed.comYesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMPlasmaSerum2021-05-10 13:18:20861Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry102272019-nCoV Ab Test (Colloidal Gold) (IgM/IgG Whole Blood/Serum/Plasma Combo)142Innovita Biological TechnologyChinawww.innovita.com.cn/YesCommercialisedNoNoStripNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:00188Immuno-AntibodyYesImmunoassayQualitativeColorimetry151562019 nCoV novel coronavirus antibody detection reagent (Colloidal gold)88Edinburgh Genetics LimitedUnited Kingdomeggenetics.com/YesCommercialisedNoNoStripNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:00120Immuno-AntibodyYesNoImmunoassayQualitativeColloidal gold10Clinical Sensitivity98% IgMClinical Sensitivity99% IgG1522019 nCOV IgG/IgM Rapid Test86Dynamiker Biotechnology (Tianjin) Co., LtdChinaen.dynamiker.com/YesCommercialisedNoNoFingertipNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:00116Immuno-AntibodyYesNoImmunoassayQualitative10Accuracy92%9210 Minutes COVID-19 IgG/IgM Rapid Test54BiomemeUnited Statesshop.biomeme.comNoCommercialisedNoNoNear POC / POCAntibodyIgGIgM2021-05-10 13:04:0065Immuno-AntibodyYesImmunoassayRapid diagnostic test 94509-nCOV IgM/IgG antibody test kits (Colloidal-gold Assay)523Shandong ThinkLab Biotechnology Co., LtdChinayq.yyigou.com/foreign_trade.htmlYesCommercialisedNoNoAutomatedManualAntibodyIgGIgM2021-05-10 13:04:00762Immuno-AntibodyImmunoassayColorimetry1649(COVID-19) IgM/IgG Test Kit (Dry Fluorescence Immunoassay)739Lansion Biotechnology Co., Ltd.Chinawww.lansionbio.com/YesCommercialisedNoNoStripAutomatedLab-basedNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:04:001330Immuno-AntibodyYesYesImmunoassayQuantitativeFluorescenceFluorescence15LOD1AUCalibrationevaluatedCrossreactivityevaluatedFp5%Fn3%PrecisionevaluatedAccuracy96%(IgM, IgG)ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity97.14%(IgM, IgG)575(COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold)545JinHuan Medical Instrument Co., LtdChinawww.jinhuan123.comYesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMWhole blood2021-05-10 13:04:00791Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry151019(COVID-19) IgG/IgM Rapid Test558NatejahSaudi Arabianatejah.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGIgM2021-05-10 13:04:00814Immuno-AntibodyYesImmunoassay1355(2019-nCoV) New coronavirus Antibody Test (Colloidal Gold)851Nantong Diagnos Biotechnology Co., LtdChinawww.diagnosbio.comYesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGIgMPlasmaSerumWhole blood2021-05-10 13:18:201115Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15LOD0AUAnalytical Sensitivity87.04% IgGAccuracy93.33% IgMAccuracy92.38% IgGClinical Sensitivity88.89% IgM1629recomWell SARS-CoV-2 IgG725Mikrogen DiagnostikGermanywww.mikrogen.deYesCommercialisedNoNoMicroplateLab-basedAntibodyIgGIgA2021-05-10 13:04:001309Immuno-AntibodyImmunoassay390CrossreactivitySeasonal coronaviruses (HCoV), Influenza A virus, Influenza B virus, Respiratory syncytial virus (RSV), Adenoviruses, Mycoplasma pneumoniae, Chlamydia pneumoniae, Epstein-Barr virus (EBV), Cytomegalovirus (CMV), Autoantibodies positive, Pregnant women, RClinical Sensitivity98% IgGClinical Sensitivity73% IgAClinical Specificity98.7% IgGClinical Specificity99.3% IgA1212Wondof SARS-CoV-2 IgG Antibody Test (Lateral Flow Method)124Guangzhou Wondfo Biotech Co., LtdChinaen.wondfo.com.cn/YesCommercialisedNoNoLateral flowNear POC / POCAntibodyIgG2021-05-10 13:04:00996Immuno-AntibodyYesImmunoassayColloidal gold1164VIROTECH SARS-CoV-2 IgG ELISA614VIROTECH Diagnostics GmbHGermanywww.virotechdiagnostics.comYesCommercialisedNoNoAutomatedManualAntibodyIgGPlasmaSerum http://www.virotechdiagnostics.com/uploads/tx_multishop/images/cmsfiles/5f05d0d67d93d.pdf2021-05-10 13:04:00949Immuno-AntibodyYesELISAQualitativeOtherClinical Sensitivity100% IgGClinical Specificity98% IgG98%)]]>Type of antigennucleoprotein880VIROTECH SARS-CoV-2 IgG445EurofinsHungarywww.eurofins-technologies.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGPlasmaSerum2021-05-10 13:04:00717Immuno-AntibodyNoYesImmunoassayQualitativeFluorescence120881VIDAS SARS-COV-2 IgG56bioMérieux SAFrancewww.biomerieux.com/YesCommercialisedNoNoAutomatedManualAntibodyIgG2021-05-10 13:04:00718Immuno-AntibodyYesImmunoassayQualitative30Clinical Sensitivity99.6%Clinical Specificity100%1149SmartEIA COVID-19 RBD IgG591TestLine Clinical Diagnostics s.r.o.Czechiawww.testlinecd.com/YesCommercialisedNoNoAutomatedManualAntibodyIgGPlasmaSerum pending patent issues 2021-05-10 13:04:00935Immuno-AntibodyNoImmunoassayQualitativeFluorescence90Clinical Sensitivity99.9%1104SmartEIA COVID-19 NP IgG591TestLine Clinical Diagnostics s.r.o.Czechiawww.testlinecd.com/YesCommercialisedNoNoMicroplateAutomatedManualAntibodyIgGPlasmaSerum https://www.testlinecd.com/smarteia-covid-19-np-igg?d=2312021-05-10 13:04:00895Immuno-AntibodyYesImmunoassaySemiquantitativeFluorescence90Clinical Sensitivity95.12%2028SG Diagnostics COVID-19 Immunity Strength Rapid Test Kit (RBD Neutralizing Antibody)932SG DiagnosticsSingaporehttps://www.sgdiagnostics.comYesCommercialisedNoNoCassetteManualAntibodyIgGPlasmaSerumWhole bloodNone2021-05-10 13:04:001706Immuno-AntibodyNoImmunochromatographyQualitativeMembrane-basedOther10Neutralizing antibodyLOD0AUCalibrationEvaluatedCrossreactivityEvaluatedFp2AUFn4AUPrecisionEvaluatedAccuracy97.07%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.19%Clinical Specificity98%Type of antigenOther1071Severe Acute Respiratory Syndrome Coronavirus 2 IgG (CLIA)576Shenzhen Mindray Bio-Medical Electronics Co., LtdChinawww.mindray.com/en/index.htmlYesCommercialisedNoNoAutomatedManualAntibodyIgGPlasmaSerum2021-05-10 13:04:00847Immuno-AntibodyCLIAChemiluminescenceCalibrationEvaluatedCrossreactivityEvaluatedPrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluated1409SCoV-2 Detect IgG ELISA139InBios InternationalUnited Statesinbios.com/YesCommercialisedNoNoMicroplateLab-basedAntibodyIgGSerum https://inbios.com/scov-2-detect-igg-elisa-kit-2/2021-05-10 13:04:001172Immuno-AntibodyNoYesELISAQualitativeMagnetic Electrochemical150Crossreactivity0% IgGfor tested agentsClinical Sensitivity97.8% IgGClinical Specificity98.95% IgG1463SARS-CoV-2-IgG-EIA-BEST680Vector-BestRussiawww.vector-best.ru/en/YesCommercialisedNoNoOtherAntibodyIgGPlasmaSerum2021-05-10 13:04:001214Immuno-AntibodyYesImmunoassayQualitative90LOD0.13IU/mlCalibrationNot evaluatedCrossreactivityevaluatedPrecisionnot evaluatedAccuracy100% IgGReproducibilityevaluatedRobustnessnot evaluatedClinical Sensitivity100% IgG571SARS-CoV-2 IgG ELISA Kit360Ideal Tashkhis Atieh Co.Iranwww.idealdiag.com/en/YesCommercialisedNoNoN.A.AutomatedManualAntibodyIgGPlasmaSerum2021-05-10 13:04:00485Immuno-AntibodyYesELISAQualitativeFluorescence75Clinical Sensitivity94.1% IgGClinical Specificity98.3% IgGType of antigennucleocapsid596SARS-CoV-2 IgG ELISA358Pishtaz Teb DiagnosticsIranwww.pishtazteb.com/enYesCommercialisedNoNoAutomatedManualAntibodyIgGPlasmaSerum2021-05-10 13:04:00503Immuno-AntibodyYesELISAQualitativeFluorescence75CrossreactivityEvalaueatedClinical Sensitivity94.1% IgGClinical Specificity98.3% IgG1076SARS-CoV-2 IgG assay576Shenzhen Mindray Bio-Medical Electronics Co., LtdChinawww.mindray.com/en/index.htmlYesCommercialisedNoNoAutomatedManualAntibodyIgGPlasmaSerum2021-05-10 13:04:00854Immuno-AntibodyImmunoassayChemiluminescenceCalibrationEvaluatedCrossreactivityEvaluatedPrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluated1482SARS-CoV-2 IgG antibody detection kit (ELISA)686Proel Biotech LtdRomaniaproelbiotech.com/YesCommercialisedNoNoAutomatedManualAntibodyIgGSerum2021-05-10 13:04:001233Immuno-AntibodyNoYesELISAQualitative110manual or automated LOD1AU1Calibrationnot evaluatedCrossreactivityevaluatedFp0%(0 as determined by testing 88 samples collected prior February 2019)Fn0%(0 as determined by testing 30 samples of recovered COVID-19 patients)PrecisionevaluatedAccuracy100% IgGReproducibilityevaluatedRobustnessnot evaluatedClinical Sensitivity100% IgG392SARS-CoV-2 IgG Ab Rapid Test262Sure Bio-Tech (USA) Co., LtdUnited Stateswww.surebiotech.com/YesCommercialisedNoNoCardNear POC / POCAntibodyIgG2021-05-10 13:04:00329Immuno-AntibodyYesImmunoassayQualitativeType of antigennucleocapsid protein989SARS-CoV-2 IgG (CLIA)168Maccura Biotechnology Co., LtdChinawww.maccura.com/enYesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGPlasmaSerum2021-05-10 13:04:00888Immuno-AntibodyYesYesImmunoassayQualitativeChemiluminescence20Clinical Sensitivity96.24%Clinical Specificity98.13%1709SARS-CoV-2 IgG (CLIA)761MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.Chinawww.medcaptain.comYesCommercialisedNoNoCassetteAutomatedManualAntibodyIgGPlasmaSerum2021-05-10 13:04:001389Immuno-AntibodyYesCLIAQualitativeChemiluminescence25Manual or automated cassette chemiluminiscence LOD2AUCalibrationevaluatedCrossreactivityevaluatedFp3.7% IgGFn3.1% IgGPrecisionevaluatedAccuracy96.5% IgGReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity96.9% IgG2042SARS-CoV-2 IgG (Chemiluminescent Immunoassay)942Suzhou Hybiome Biomedical Engineering Co., Ltd.Chinahttps://www.hybiome.com/YesCommercialisedNoNoOtherAutomatedLab-basedAntibodyIgGPlasmaSerumS-RBD, physical support= magnetic microparticles2021-05-10 13:04:001720Immuno-AntibodyYesCLIAQualitativeChemiluminescence60LOD0AUCalibrationEvaluatedCrossreactivityEvaluatedFp1.1% IgGFn0.6% IgGPrecisionEvaluatedAccuracy99.1% IgGReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.4% IgGClinical Specificity98.9% IgGType of antigenOther701SARS-CoV-2 IgG6AbbottUnited Stateswww.abbott.com/YesCommercialisedNoNoAutomatedManualAntibodyIgGPlasmaSerum2021-05-10 13:04:00584Immuno-AntibodyNoImmunoassayQualitativeNot foundN.A.29FpFour false positives out of a total of 1070 negative specimens.Fn/=14 days post-symptom onset. ]]>PrecisionEvaluatedAccuracy99.45% IgGReproducibilityNot EvaluatedRobustnessEvaluatedClinical Sensitivity100% IgGClinical Specificity99%181/1821053SARS-CoV-2 IgG526DIALAB GmbHAustriawww.dialab.at/en/home/YesCommercialisedNoNoMicroplateLab-basedAntibodyIgGPlasmaSerum2021-05-10 13:04:00828Immuno-AntibodyYesImmunoassayQualitativeMagnetic Electrochemical70CrossreactivityNo cross reactivity observed with samples positive to RSV IgM/IgG/Antibodies and MP IgM/IgG/Antibodies.No interference with rheumatic factor up to 2000 U/mL, bilirubin 35 mg/dL or haemoglobin 0.9 g/dL observed.No cross specificity with similar pathogClinical Sensitivity100%(15/15)Clinical Specificity99.87%(3018/3022)914SARS-CoV IgG ELISA512Ansh LabsUnited Stateswww.anshlabs.com/YesCommercialisedNoNoLab-basedAntibodyIgGPlasmaSerum2021-05-10 13:04:00740Immuno-AntibodyNoYesELISAQualitativeFluorescence120CrossreactivityEvaluatedClinical Sensitivity95%Clinical Specificity98.3%475OZO Gold - OZO SARS-CoV-2 IgG Method226OZO LifeUnited Kingdomwww.ozo.life/YesCommercialisedNoNoLateral flowAutomatedManualAntibodyIgGWhole blood OZO INDIA SARS-COV-2 IGM/IGG RAPID TEST Kit and OZO Diamond - OZO SARS-CoV-2 IgM + IgG Method are the only two kits available in the company's website2021-05-10 13:04:00397Immuno-AntibodyNoImmunoassayQualitativeColorimetry15Accuracy98%Type of antigenRecombinant SARS-CoV-2 IgM antigens432Novel Coronavirus IgG antibody test kit (colloidal gold method)273Wuhan Easydiagnosis Biomedicine Co., LtdChinawww.mdeasydiagnosis.com/YesCommercialisedNoNoNear POC / POCAntibodyIgGWhole blood2021-05-10 13:04:00361Immuno-AntibodyYesImmunoassayQualitativeType of antigennucleoprotein725NovaLisa SARS-CoV-2 IgG assay445EurofinsHungarywww.eurofins-technologies.com/YesCommercialisedNoNoAutomatedManualAntibodyIgGSerum2021-05-10 13:04:00605Immuno-AntibodyImmunoassayQualitativeFluorescenceManual or automated Fluorescence 588NovaLisa COVID-19 (SARS-CoV-2) IgG368NovaTec Immundiagnostica GmbHGermanywww.novatec-id.com/YesCommercialisedNoNoAutomatedManualAntibodyIgGPlasmaSerum2021-05-10 13:04:00497Immuno-AntibodyYesImmunoassayQualitativeFluorescence1087NAISSA SARS-COV-2 IgG585Neomedica d.o.o.Senegalwww.neomedica.rsYesCommercialisedNoNoCartridgeAutomatedAntibodyIgGPlasmaSerum https://neomedica.rs/products/immunodiagnostics/monotest-immunoanalyzer-naissa/naissa-new/2021-05-10 13:04:00870Immuno-AntibodyYesImmunoassayQualitativeSandwich, Double150CalibrationEvaluatedCrossreactivityEvaluatedFp1AUFn0AUPrecisionEvaluatedAccuracy99%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity97.5%1107Microblot-Array COVID-19 IgG591TestLine Clinical Diagnostics s.r.o.Czechiawww.testlinecd.com/YesCommercialisedNoNoDotblotMicroblotAutomatedManualAntibodyIgGPlasmaSerum https://www.trivitron.com/uploads/brochure/15897931402Covid_Flyer_-_Biocard_Test_V.2.pdf https://www.testlinecd.com/microblot-array-covid-19-igg?d=2312021-05-10 13:04:00884Immuno-AntibodyYesImmunoassayQuantitativeFluorescence75Clinical Sensitivity98.71%1299MAGLUMI SARS-CoV-2 S-RBD IgG (CLIA)255Snibe Co., LtdChinawww.snibe.com/YesCommercialisedNoNoAutomatedManualAntibodyIgGPlasmaSerum2021-05-10 13:04:001069Immuno-AntibodyCLIAQuantitativeManual or automated other Clinical Sensitivity0-7days Post Onset of Symptoms: 74.5%; 8-14 days Post Onset of Symptoms: 97.9%; ? 15 days: 100%374MAGLUMI 2019-nCoV IgG (CLIA)255Snibe Co., LtdChinawww.snibe.com/YesCommercialisedNoNoAutomatedManualAntibodyIgGPlasmaSerum2021-05-10 13:04:00318Immuno-AntibodyYesImmunoassayQuantitative301034Maccura SARS-CoV-2 IgG168Maccura Biotechnology Co., LtdChinawww.maccura.com/enYesCommercialisedNoNoCardNear POC / POCAntibodyIgGPlasmaSerum2021-05-10 13:04:00792Immuno-AntibodyYesImmunoassayQualitativeChemiluminescence20Clinical Sensitivity98.13%Clinical Specificity97.15%911LIAISON SARS-CoV-2 S1/S2 IgG511DiaSorin S.p.AItalywww.diasorin.com/YesCommercialisedNoNoAutomatedAntibodyIgGPlasmaSerum2021-05-10 13:04:00738Immuno-AntibodyYesImmunoassayQuantitativeChemiluminescence35CrossreactivityEvaluatedClinical Sensitivity97.4%Clinical Specificity98.9%69Kewei COVID-19 IgG antibody ELISA Test Kit43Beijing Kewei Clinical Diagnostic Reagent IncChinaen.keweidiagnostic.com/YesCommercialisedNoNoMicrotiter plateAutomatedManualAntibodyIgGPlasmaSerum2021-05-10 13:04:0050Immuno-AntibodyNoYesELISAQualitativeMagnetic Electrochemical60Accuracy96% IgGClinical Sensitivity90.83% IgGClinical Specificity99.2% IgG1079iFlash-SARS-CoV-2 IgG379SHENZHEN YHLO BIOTECH CO., LtdChinawww.szyhlo.comYesCommercialisedNoNoAutomatedManualAntibodyIgGPlasmaSerum https://pdf.medicalexpo.com/pdf/shenzhen-yhlo-biotech-co-ltd/clia-iflash-3000/107786-227346.html2021-05-10 13:04:001726ID Screen® SARS-CoV-2-N IgG Indirect766Innovative DiagnosticsFrancewww.innovative-diagnostics.com/YesCommercialisedNoNoOtherAutomatedManualAntibodyIgGPlasmaSerum2021-05-10 13:04:001406Immuno-AntibodyNoYesELISAQualitative95LOD0AUCalibrationevaluatedCrossreactivityevaluatedFp0.4% IgG5 false positive on 1242 samples tested negative by PCRFn4.8% IgG4 false negative on 84 samples tested positive by PCRPrecisionevaluatedAccuracy99.6ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity95.2% IgGType of antigennucleoprotein859ID Screen SARS-CoV-2-N IgG Indirect ELISA Kit (manual, automated)41ID.vetFrancewww.id-vet.com/YesCommercialisedNoNoAutomatedManualAntibodyIgGPlasmaSerum2021-05-10 13:04:0048Immuno-AntibodyYesELISASemiquantitativeFluorescence95Clinical Sensitivity99.9% IgGClinical Specificity99.9% IgG1125Human anti-SARS-CoV-2 IgG ELISA Kit367MP BiomedicalsUnited Stateswww.mpbio.com/YesCommercialisedNoNoMicrotiter plateAutomatedManualAntibodyIgGOther biological fluidsPlasmaTissue homogenateshttps://www.mpbio.com/us/human-anti-sars-cov-2-igg-elisa-kit2021-05-10 13:04:00908Immuno-AntibodyYesELISAQuantitativeN.A.Clinical Sensitivity2.34ng/mL1671Foresight SARS-CoV-2 IgG EIA Test Kit683ACON Laboratories, IncUnited Stateswww.aconlabs.comYesCommercialisedNoNoAutomatedManualAntibodyIgGPlasmaSerum2021-05-10 13:04:001350Immuno-AntibodyYesImmunoassayQualitativeOther30LOD0.67AUCalibrationevaluatedCrossreactivityevaluatedPrecisionevaluatedAccuracy97.21%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity91.64%1424Foresight SARS-CoV-2 IgG565Acon Biotech (Hangzhou) Co., LtdChinawww.aconbio.com/YesCommercialisedNoNoMicroplateLab-basedAntibodyIgGPlasmaSerum https://www.aconlabs.com.cn/en/ACON/687.html2021-05-10 13:04:001183Immuno-AntibodyYesImmunoassayQualitativeMagnetic Electrochemical75Accuracy99.6%Clinical Sensitivity99.9%Clinical Specificity99.4%1191Finecare SARS-CoV-2 IgG Test124Guangzhou Wondfo Biotech Co., LtdChinaen.wondfo.com.cn/YesCommercialisedNoNoNear POC / POCAntibodyIgG2021-05-10 13:04:00976Immuno-AntibodyYesYesImmunoassayFluorescenceRapid diagnostic test Fluorescence 977Immuno-AntibodyYesImmunoassayRapid diagnostic test 533ErbaLisa COVID-19 IgG ELISA327Erba MannheimUnited Kingdomwww.erbamannheim.comYesCommercialisedNoNoAutomatedManualAntibodyIgGPlasmaSerum2021-05-10 13:04:00436Immuno-AntibodyYesELISASemiquantitativeSandwich, Double50CrossreactivityEvaluatedPrecision6.37% IgG5.29% - 6.37%Clinical Sensitivity98.3% IgGClinical Specificity98.1% IgG1720Epithod®616 IgG Test Kit763DxGen Corp.South Koreawww.dxgenco.comYesCommercialisedNoNoCassetteAutomatedManualAntibodyIgGSerumWhole blood2021-05-10 13:04:001400Immuno-AntibodyYesYesImmunoassayQuantitative3LOD10000AUCalibrationevaluatedCrossreactivityevaluatedFp24Positive percent agreement (PPA) was determined by testing 97 positive samples with a clinical diagnosis of COVID-19 based on a positive PCR method. Overall, 88% of the positive samples yielded an IgG positive result with 0-7 days (35/46, 76%), 8-14 daysFn5Negative percent agreement (NPA) was determined by testing 100 negative samples, including 2 negative conversion samples from recovered patients. Overall, 95% of the negative samples yielded an IgG negative result. Precisionnot evaluatedAccuracy88% IgGReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity88% IgGType of antigennucleoprotein1719Epithod® SARS-CoV-2 IgG Test Kit763DxGen Corp.South Koreawww.dxgenco.comYesCommercialisedNoNoCassetteAutomatedManualAntibodyIgGSerumWhole blood2021-05-10 13:04:001399Immuno-AntibodyYesYesImmunoassay3LOD10000AUCalibrationevaluatedCrossreactivityevaluatedFpPositive percent agreement (PPA) was determined by testing 97 positive samples with a clinical diagnosis of COVID-19 based on a positive PCR method. Overall, 88% of the positive samples yielded an IgG positive result with 0-7 days (35/46, 76%), 8-14 daysFnNegative percent agreement (NPA) was determined by testing 100 negative samples, including 2 negative conversion samples from recovered patients. Overall, 95% of the negative samples yielded an IgG negative result. Precisionnot evaluatedAccuracy88% IgGReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity88% IgGType of antigennucleoprotein981ENZY-WELL SARS-CoV-2 IgG543DIESSE Diagnostica Senese SPAItalywww.diesse.it/YesCommercialisedNoNoAutomatedManualAntibodyIgGPlasmaSerum2021-05-10 13:04:00787Immuno-AntibodyYesImmunoassayQualitativeFluorescence135CrossreactivityReportedClinical Sensitivity92.5%Clinical Specificity95.8%1414EliA SARS-CoV-2-Sp1 IgG test260Thermo Fisher ScientificUnited Stateswww.thermofisher.com/ch/en/home.htmlYesCommercialisedNoNoLab-basedAntibodyIgGPlasmaSerum https://thermofisher.mediaroom.com/2020-10-12-Thermo-Fisher-Scientific-Further-Expands-COVID-19-Test-Portfolio-with-Two-New-Antibody-Tests2021-05-10 13:04:001175Immuno-AntibodyYesImmunoassayQuantitativeFluorescenceClinical Sensitivity100%Clinical Specificity99.7%Type of antigenspike glycoprotein (S protein)1137EIA COVID-19 RBD IgG591TestLine Clinical Diagnostics s.r.o.Czechiawww.testlinecd.com/YesCommercialisedNoNoAutomatedManualAntibodyIgGPlasmaSerum pending patent issues 2021-05-10 13:04:00926Immuno-AntibodyYesImmunoassayQuantitativeFluorescence90Clinical Sensitivity99.9%1101EIA COVID-19 NP IgG591TestLine Clinical Diagnostics s.r.o.Czechiawww.testlinecd.com/YesCommercialisedNoNoMicroplateAutomatedManualAntibodyIgGPlasmaSerum https://www.testlinecd.com/eia-covid-19-np-igg2021-05-10 13:04:00892Immuno-AntibodyYesImmunoassaySemiquantitativeFluorescence90Clinical Sensitivity95.12%157EDI Novel Coronavirus COVID-19 IgG ELISA Kit94Epitope Diagnostics, IncUnited Stateswww.epitopediagnostics.com/YesCommercialisedNoNoAutomatedManualAntibodyIgGPlasmaSerum2021-05-10 13:04:00121Immuno-AntibodyNoYesELISAQuantitativeFluorescence120Clinical Sensitivity100% IgGClinical Specificity100% IgG670Diazyme DZ-LITE SARS-CoV-2 IgG390Diazyme LaboratoriesUnited Stateswww.diazyme.com/NoCommercialisedNoNoLab-basedAntibodyIgGSerum2021-05-10 13:04:00538Immuno-AntibodyYesImmunoassayQualitativeChemiluminescence Other Chemiluminescence Clinical Sensitivity100%Clinical Specificity97.4%1673COVID5GDIV-24749D-tek s.a.Belgiumwww.d-tek.beYesCommercialisedNoNoStripAutomatedManualAntibodyIgGSerum2021-05-10 13:04:001352Immuno-AntibodyNoNoImmunoassayQualitativeOther60 LOD5AUCalibrationevaluatedCrossreactivityevaluatedFp5%Fn5%PrecisionevaluatedAccuracy100% IgGReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity100% IgG422COVID-19 VIRCLIA IgG MONOTEST78Vircell S.L.Spainwww.vircell.com/YesCommercialisedNoNoAutomatedManualAntibodyIgGPlasmaSerum2021-05-10 13:04:0098Immuno-AntibodyYesImmunoassayQualitativeChemiluminescence1384COVID-19 IgG Rapid Test (strip)126Hangzhou AllTest Biotech Co., LtdChinawww.alltests.com.cn/YesCommercialisedNoNoStripNear POC / POCAntibodyIgGPlasmaSerumWhole blood2021-05-10 13:04:001150Immuno-AntibodyYesNoImmunoassayQualitative10LOD0CalibrationNot evaluatedCrossreactivityEvaluatedFp4.7%Fn5.7%Accuracy96% IgGRobustnessNot evaluatedClinical Sensitivity94.3% IgG1383COVID-19 IgG Rapid Test (cassette)126Hangzhou AllTest Biotech Co., LtdChinawww.alltests.com.cn/YesCommercialisedNoNoCassetteLateral flowNear POC / POCAntibodyIgGPlasmaSerumWhole blood2021-05-10 13:04:001149Immuno-AntibodyYesNoImmunoassayQualitative10Rapid diagnostic test lateral flow LOD0AUCalibrationNot evaluatedFp4.7%Fn5.7%Accuracy95% IgGRobustnessNot evaluatedClinical Sensitivity94.3% IgG1395COVID-19 IgG Rapid Test659CITEST DIAGNOSTICS INCCanadawww.citestdiagnostics.com/YesCommercialisedNoNoCassetteNear POC / POCAntibodyIgGPlasmaSerumWhole blood2021-05-10 13:04:001161Immuno-AntibodyYesNoImmunoassayQualitative10LOD0CalibrationNot evaluatedFp4.7%Fn%5.70%Accuracy95% IgGClinical Sensitivity94.3% IgG1695COVID-19 IgG Rapid Test890Acro Biotech IncUnited Stateswww.acrobiotech.comYesCommercialisedNoNoLateral flowNear POC / POCAntibodyIgGPlasmaSerumWhole blood2021-05-10 13:18:201374Immuno-AntibodyYesNoImmunoassayQualitative10LOD0AUCalibrationnot evaluatedCrossreactivityevaluatedFp4.7AUFn5.7AUPrecisionevaluatedAccuracy95% IgGReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity94.3% IgG1327COVID-19 IgG ELISA410Monocent, IncUnited Stateswww.monocent.comYesCommercialisedNoNoAutomatedManualAntibodyIgGPlasmaSerum2021-05-10 13:04:001096Immuno-AntibodyYesELISAQualitative70Manual or automated Accuracy97% IgGClinical Sensitivity95% IgGType of antigennucleoprotein425COVID-19 ELISA IgG78Vircell S.L.Spainwww.vircell.com/YesCommercialisedNoNoAutomatedManualAntibodyIgGPlasmaSerum2021-05-10 13:04:00355Immuno-AntibodyELISAQualitativeFluorescence1386COVID-19 and M.pneumoniae IgG Combo Rapid Test126Hangzhou AllTest Biotech Co., LtdChinawww.alltests.com.cn/YesCommercialisedNoNoLateral flowNear POC / POCAntibodyIgGPlasmaSerumWhole blood2021-05-10 13:04:001152Immuno-AntibodyYesNoImmunoassayQualitative10CalibrationNot evaluatedFp2% IgG5.4% IgG (M.pneumoniae)Fn0%7.8% IgG (M.pneumoniae)RobustnessNot evaluatedClinical Sensitivity100% IgG+ (Mycoplasma pneumoniae= 92.2% IgG )Clinical Specificity98.6% IgG+ (Mycoplasma pneumoniae = 93.7% IgG )1698COVID-19 and M.pneumoniae IgG Combo Rapid Test890Acro Biotech IncUnited Stateswww.acrobiotech.comYesCommercialisedNoNoLateral flowNear POC / POCAntibodyIgGPlasmaSerumWhole blood2021-05-10 13:18:201377Immuno-AntibodyYesNoImmunoassayQualitative10LOD0Calibrationnot evaluatedCrossreactivityevaluatedFp2Fn0PrecisionevaluatedAccuracy100% IgGReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity100% IgG841COVID-19 (SARS-CoV-2) IgG ELISA489Demeditec Diagnostics GmbHGermanywww.demeditec.com/YesCommercialisedNoNoAutomatedManualAntibodyIgGPlasmaSerum2021-05-10 13:04:00690Immuno-AntibodyNoYesELISAQualitativeFluorescenceCrossreactivityEvaluatedClinical Sensitivity100% IgGRange: 7.69 - 100Clinical Specificity99.24% IgG1117COVID KAVACH Anti-SARS CoV-2 Human IgG ELISA19Trivitron Healthcare Pvt. LtdIndiawww.trivitron.com/YesCommercialisedNoNoAutomatedManualAntibodyIgGPlasmaSerum https://www.lumiradx.com/assets/pdfs/covid-19-antigen-test/sars-cov-2-ag-test-spec-sheet-ous.pdf; https://www.lumiradx.com/assets/pdfs/covid-19-antigen-test/sars-cov-2-ag-qc-product-insert-en-fr-de-it-es-se.pdf; https://www.lumiradx.com/assets/images/new/pdf/sars-cov-2-ag-qri-us-ous.pdf 2021-05-10 13:04:00898Immuno-AntibodyNoYesELISAQualitativeMagnetic Electrochemical130Manual or automated Sandwich, Double colorimetry Clinical Sensitivity98% IgGClinical Specificity100% IgGType of antigenSARS-CoV-2 Nucleocapsid Protein (NP) antigen539COV19CONF.CE - ELISA COVID 19 IgG Confirmatory341DIA.PRO Diagnostic Bioprobes SrlItalywww.diapro.it/YesCommercialisedNoNoAutomatedManualAntibodyIgGPlasmaSerum2021-05-10 13:04:00455Immuno-AntibodyYesELISAQualitativeFluorescence537BioProbes Srl COV19G.CE - ELISA COVID 19 IgG341DIA.PRO Diagnostic Bioprobes SrlItalywww.diapro.it/YesCommercialisedNoNoAutomatedManualAntibodyIgGPlasmaSerum2021-05-10 13:04:00453Immuno-AntibodyYesELISAQualitativeFluorescence453BIOCELL COVID-19 IgG ELISA test292Zhengzhou Humanwell Biocell Biotechnology Co., LtdChinawww.cnbiocell.com/YesCommercialisedNoNoAutomatedManualAntibodyIgGPlasmaSerum2021-05-10 13:04:00379Immuno-AntibodyYesELISAQualitativeFluorescence1499Bio-Shield 2019-nCoV IgG688Prognosis BiotechGreecewww.prognosis-biotech.com/YesCommercialisedNoNoAutomatedManualAntibodyIgGPlasmaSerumWhole blood2021-05-10 13:04:001249Immuno-AntibodyYesImmunoassayQualitativeOther90LOD1AUCalibrationevaluatedCrossreactivityevaluatedFp1%Fn2%PrecisionevaluatedAccuracy99.59%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity99.85%772Atlas COVID-19 S1-RBD IgG Elisa Kit314Atlas MedicalUnited Kingdomatlas-medical.com/YesCommercialisedNoNoN.A.AutomatedManualAntibodyIgGSerum2021-05-10 13:04:00626Immuno-AntibodyNoYesELISAQualitative70Manual or automated 2023Atellica IM SARS-CoV-2 IgG (sCOVG)444Siemens HealthineersGermanywww.siemens-healthineers.comYesCommercialisedNoNoOtherLab-basedAntibodyIgGOtherPlasmaSerumGood correlation and strong relationship between Index values and neutralizing antibody titers.2021-05-10 13:04:001701Immuno-AntibodyNoImmunoassayQuantitativeSandwich25support: Magnetic particlesLOD0.5AUCalibrationEvaluatedCrossreactivityEvaluatedPrecisionEvaluatedAccuracyIgGReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.41%@ 21 days after PCR: (95% CI):92.74%–98.54%))Clinical Specificity99.9%(95% CI: 99.64%–99.99%)849Anti-SARS-CoV-2-NCP ELISA (IgG)90EUROIMMUN AGGermanywww.coronavirus-diagnostics.com/YesCommercialisedNoNoAutomatedManualAntibodyIgGPlasmaSerum2021-05-10 13:04:001625Anti-SARS-CoV-2 IgG ELISA723MediagnostGermanymediagnost.deYesCommercialisedNoNoStripLab-basedAntibodyIgGPlasmaSerum2021-05-10 13:04:001552Immuno-AntibodyELISAAnalitical Specificity98.6CrossreactivityBeta Corona HKU1, SARS-CoV, VZV, HCV, HAV, HBV, EBV, CMV, HSVAccuracy96.99Clinical Sensitivity95.3(69.4-95.3)%1099Anti-SARS-CoV-2 IgG590Biocheck GmbHGermanywww.polycheck.deYesCommercialisedNoNoN.A.AutomatedManualAntibodyIgGPlasmaSerumhttps://polycheck.de/wp-content/uploads/2020/07/Polycheck-Anti-SARS-CoV-2-IgG-Flyer.pdf2021-05-10 13:04:00880Immuno-AntibodyNoNoImmunoassayQuantitativeMagnetic Electrochemical105Manual or automated microblot colorimetry LOD0.2KU/lCrossreactivityEvaluatedReproducibilityEvaluatedClinical Sensitivity98.6% IgGClinical Specificity98.7% IgG1657Anti-SARS-Cov-2 ELISA IgG742Immunostep S.LSpainwww.immunostep.com/YesCommercialisedNoNoAutomatedManualAntibodyIgGPlasmaSerum2021-05-10 13:04:001336Immuno-AntibodyNoYesELISAQualitativeFluorescence120Manual or automated fluorescence LOD0CalibrationevaluatedCrossreactivityevaluatedFpSee technical Data SheetFnSee technical Data SheetPrecisionevaluatedAccuracySee technical Data SheetReproducibilityevaluatedRobustnessevaluatedClinical SensitivitySee technical Data Sheet883Anti-SARS-CoV-2 ELISA (IgG)90EUROIMMUN AGGermanywww.coronavirus-diagnostics.com/YesCommercialisedNoNoAutomatedManualAntibodyIgGPlasmaSerum2021-05-10 13:04:00720Immuno-AntibodyYesELISAQualitativeFluorescenceClinical Sensitivity93.8% IgG(75 - 93.8)Clinical Specificity99.6% IgG1092AESKULISA SARS-CoV-2 NP IgG586Aesku.DiagnosticsGermanywww.aesku.comYesCommercialisedNoNoAutomatedManualAntibodyIgG Additional info: http://en.diagreat.com/Private/Files/20200402/6372142198788930846626315.pdf https://www.aesku.com/index.php/diagnostics/aeskulisa-elisa-test-kits/infectious-serology-elisa/item/3982021-05-10 13:04:00872Immuno-AntibodyYesImmunoassayQuantitativeMagnetic ElectrochemicalClinical Sensitivity95.2%Clinical Specificity99%2022ADVIA Centaur CP SARS-CoV-2 IgG (sCOVG)444Siemens HealthineersGermanywww.siemens-healthineers.comYesCommercialisedNoNoOtherLab-basedOtherAntibodyIgGOtherPlasmaSerumGood correlation and strong relationship between Index values and neutralizing antibody titers2021-05-10 13:04:001700Immuno-AntibodyImmunoassayQuantitativeSandwich50LOD0.5AUCalibrationEvaluatedCrossreactivityEvaluatedFp-Fn-PrecisionEvaluatedAccuracyIgGReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity96.41%@ 21 days after PCR : (95% CI: 92.74%–98.54%)Clinical Specificity99.9%(95% CI: 99.64%–99.99%)1307Accudiag SCoV-2 IgG ELISA582Diagnostic Automation/Cortez Diagnostics, IncUnited Stateswww.rapidtest.comYesCommercialisedNoNoAutomatedManualAntibodyIgGSerum2021-05-10 13:04:001079Immuno-AntibodyNoYesELISAQualitative150Clinical Sensitivity97.8% IgGClinical Specificity98.9% IgG17932019-nCoV-IgG Assay Reagent Kit (CMIA)344Hangzhou Realy Tech Co., LtdChinawww.realytech.com/YesCommercialisedNoNoOtherNear POC / POCAntibodyIgGSerum2021-05-10 13:04:001472Immuno-AntibodyYesImmunoassayQualitativeChemiluminescence40Fp0.48%Fn1.11%Accuracy99%Clinical Sensitivity98.89%10842019-nCoV IgG Control379SHENZHEN YHLO BIOTECH CO., LtdChinawww.szyhlo.comYesCommercialisedNoNoOtherAntibodyIgG2021-05-10 13:04:00867Immuno-AntibodyYesImmunoassayCalibrant / control sample8442019-nCOV IgG Antibody kit (ELISA)86Dynamiker Biotechnology (Tianjin) Co., LtdChinaen.dynamiker.com/YesCommercialisedNoNoAutomatedManualAntibodyIgG2021-05-10 13:04:00693Immuno-AntibodyELISANot foundManual or automated Not found Not found 632019-nCoV IgG Antibody Determination Kit38Beijing Diagreat Biotechnologies Co., LtdChinawww.diagreat.com/YesCommercialisedNoNoStripNear POC / POCAntibodyIgGWhole blood2021-05-10 13:04:0045Immuno-AntibodyYesYesImmunoassayQualitativeFluorescenceFluorescence15CrossreactivityEvaluated1166VIROTECH SARS-CoV-2 IgA ELISA614VIROTECH Diagnostics GmbHGermanywww.virotechdiagnostics.comYesCommercialisedNoNoAutomatedManualAntibodyIgAPlasmaSerum http://www.virotechdiagnostics.com/uploads/tx_multishop/images/cmsfiles/5f05d0d67d93d.pdf2021-05-10 13:04:00951Immuno-AntibodyYesELISAQualitativeOthermanual or automated other Clinical Sensitivity100% IgAClinical Specificity98% IgA98%)]]>1148SmartEIA COVID-19 RBD IgA591TestLine Clinical Diagnostics s.r.o.Czechiawww.testlinecd.com/YesCommercialisedNoNoAutomatedManualAntibodyIgAPlasmaSerum pending patent issues 2021-05-10 13:04:00934Immuno-AntibodyNoImmunoassayQualitativeFluorescence90Clinical Sensitivity96.6%1103SmartEIA COVID-19 NP IgA591TestLine Clinical Diagnostics s.r.o.Czechiawww.testlinecd.com/YesCommercialisedNoNoMicroplateAutomatedManualAntibodyIgAPlasmaSerum https://www.testlinecd.com/smarteia-covid-19-np-iga?d=2312021-05-10 13:04:00894Immuno-AntibodyYesImmunoassaySemiquantitativeFluorescence90Clinical Sensitivity97.43%1658SARS-CoV-2 Neutralizing Antibody Test Kit678Vitrosens Biotechnology Co., LtdTurkeywww.vitrosens.comYesCommercialisedNoNoCassetteNear POC / POCAntibodyIgAPlasmaSerumWhole blood2021-05-10 13:18:201337Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15LOD100AUCalibrationevaluatedCrossreactivityevaluatedFp4AUFn1AUPrecisionevaluatedAccuracy98.3%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity95.6%1147SARS-CoV-2 Antibody Test252LumiraDXUnited Kingdomwww.lumiradx.comYesCommercialisedNoNoNear POC / POCAntibodyIgAPlasmaSerumWhole blood https://www.lumiradx.com/uk-en/what-we-do/diagnostics/test-technology/antibody-test; https://www.lumiradx.com/assets/pdfs/covid-19-antibody-test/s-com-art-00532_r2_sars_cov-2_ab_test_strip_product_insert_ce.pdf2021-05-10 13:04:00338Immuno-AntibodyYesYesImmunoassayQualitativeImmunofluorescence11Crossreactivity not cross reactivity with samples positive for antibody to Influenza A, Influenza B, Hepatitis C Virus, Hepatitis B Virus (Genotype D) Hemophilus influenzae, human coronaviruses (HKU1, NL63, OC43 and 229E), Anti-Nuclear Antibody, Respiratory Syncytial VClinical Sensitivity97.2%Clinical Specificity100%1496Rapid test 2019-nCoV Total Ig688Prognosis BiotechGreecewww.prognosis-biotech.com/YesCommercialisedNoNoStripAutomatedManualAntibodyIgAPlasmaSerumWhole blood2021-05-10 13:04:001246Immuno-AntibodyYesNoImmunoassayQualitative10LOD1AUCalibrationevaluatedCrossreactivityevaluatedFp1%Fn4%PrecisionevaluatedAccuracy99.15%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity96.72%44Quantitative Immuno-kinetic assay for Covid-19 IgG+IgM+IgA for a multiantigen panel with CRP27Attomarker LtdUnited Kingdomwww.attomarker.com/NoIn developmentNoNoAutomatedManualAntibodyIgA2021-05-10 13:04:0032Immuno-AntibodyImmunoassay587NovaLisa COVID-19 (SARS-CoV-2) IgA368NovaTec Immundiagnostica GmbHGermanywww.novatec-id.com/YesCommercialisedNoNoAutomatedManualAntibodyIgAPlasmaSerum2021-05-10 13:04:00496Immuno-AntibodyYesELISAQualitativeFluorescenceType of antigenspike (S1) and nucleocapsid (N)1134NAISSA SARS-COV-2 IgA585Neomedica d.o.o.Senegalwww.neomedica.rsYesCommercialisedNoNoCartridgeAutomatedAntibodyIgAPlasmaSerum https://neomedica.rs/products/immunodiagnostics/monotest-immunoanalyzer-naissa/naissa-new/2021-05-10 13:04:00916Immuno-AntibodyYesImmunoassayQualitativeSandwich, Double150CalibrationEvaluatedCrossreactivityEvaluatedFp1AUFn0AUPrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity93.4%1106Microblot-Array COVID-19 IgA591TestLine Clinical Diagnostics s.r.o.Czechiawww.testlinecd.com/YesCommercialisedNoNoDotblotMicroblotAutomatedManualAntibodyIgAPlasmaSerum https://www.testlinecd.com/microblot-array-covid-19-iga?d=2312021-05-10 13:04:00882Immuno-AntibodyYesImmunoassayQuantitativeFluorescence75Clinical Sensitivity98.28%1683INGEZIM Covid 19 DR445EurofinsHungarywww.eurofins-technologies.com/YesCommercialisedNoNoNear POC / POCAntibodyIgAPlasmaSerumWhole blood2021-05-10 13:18:201362Immuno-AntibodyNoYesImmunoassayQualitative75LOD0AUCalibrationevaluatedCrossreactivityevaluatedFp1%Fn1%PrecisionevaluatedAccuracy97%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity98.3%Type of antigennucleoprotein1081iFlash-2019-nCoV IgA379SHENZHEN YHLO BIOTECH CO., LtdChinawww.szyhlo.comYesCommercialisedNoNoAutomatedManualAntibodyIgAPlasmaSerum2021-05-10 13:04:00866Immuno-AntibodyYesImmunoassayQualitativeChemiluminescence1727ID Screen® SARS-CoV-2 Double Antigen Multi-species766Innovative DiagnosticsFrancewww.innovative-diagnostics.com/YesCommercialisedNoNoOtherAutomatedManualAntibodyIgAPlasmaSerumWhole blood2021-05-10 13:04:001407Immuno-AntibodyYesImmunoassayQualitative95LOD0AUCalibrationevaluatedCrossreactivityevaluatedFp0.9%7 false positive on 788 samples tested negative by PCRFn0%Precisionnot evaluatedAccuracynot evaluatedReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity100Type of antigennucleoprotein1083GLINE-2019-nCoV IgA379SHENZHEN YHLO BIOTECH CO., LtdChinawww.szyhlo.comYesCommercialisedNoNoCardNear POC / POCAntibodyIgAPlasmaWhole blood2021-05-10 13:04:00524Immuno-AntibodyYesImmunoassayQualitativeColorimetry15980ENZY-WELL SARS-CoV-2 IgA543DIESSE Diagnostica Senese SPAItalywww.diesse.it/YesCommercialisedNoNoAutomatedManualAntibodyIgAPlasmaSerum2021-05-10 13:04:00786Immuno-AntibodyYesImmunoassayQualitativeFluorescence135CrossreactivityEvaluatedClinical Sensitivity93.7%Clinical Specificity96.3%1136EIA COVID-19 RBD IgA591TestLine Clinical Diagnostics s.r.o.Czechiawww.testlinecd.com/YesCommercialisedNoNoAutomatedManualAntibodyIgAPlasmaSerum pending patent issues 2021-05-10 13:04:00925Immuno-AntibodyYesImmunoassayQualitativeFluorescence90Clinical Sensitivity96.6%1100EIA COVID-19 NP IgA591TestLine Clinical Diagnostics s.r.o.Czechiawww.testlinecd.com/YesCommercialisedNoNoMicroplateAutomatedManualAntibodyIgAPlasmaSerum https://www.testlinecd.com/eia-covid-19-np-iga2021-05-10 13:04:00891Immuno-AntibodyYesImmunoassaySemiquantitativeFluorescence90Clinical Sensitivity97.43%1329COVID-19 IgA ELISA410Monocent, IncUnited Stateswww.monocent.comYesCommercialisedNoNoAutomatedManualAntibodyIgA2021-05-10 13:04:001098Immuno-AntibodyYesELISAQualitative85Manual or automated Accuracy99.59% IgAClinical Sensitivity98.7% IgAType of antigennucleoprotein840COVID-19 (SARS-CoV-2) IgA ELISA489Demeditec Diagnostics GmbHGermanywww.demeditec.com/YesCommercialisedNoNoN.A.AutomatedManualAntibodyIgAPlasmaSerum2021-05-10 13:04:00689Immuno-AntibodyN.A.YesELISAQualitativeFluorescenceN.A.CrossreactivityEvaluatedClinical Sensitivity100%7.69 - 100Clinical Specificity98.26%1626Anti-SARS-CoV-2 IgA ELISA723MediagnostGermanymediagnost.deNoCommercialisedNoNoStripManualAntibodyIgAPlasmaSerum2021-05-10 13:04:001306Immuno-AntibodyELISAAccuracy95%Clinical Sensitivity77.8%CI range 77.8-100%Clinical Specificity98%Type of antigenRBD1656Anti-SARS-Cov-2 ELISA IgA742Immunostep S.LSpainwww.immunostep.com/YesCommercialisedNoNoAutomatedManualAntibodyIgAPlasmaSerum2021-05-10 13:04:001335Immuno-AntibodyYesELISAQualitativeFluorescence120LOD0AUCalibrationevaluatedCrossreactivityevaluatedPrecisionevaluatedReproducibilityevaluatedRobustnessevaluated160Anti-SARS-CoV-2 ELISA (IgA)90EUROIMMUN AGGermanywww.coronavirus-diagnostics.com/YesCommercialisedNoNoAutomatedManualAntibodyIgAPlasmaSerum2021-05-10 13:04:00124Immuno-AntibodyYesELISAQualitativeFluorescenceClinical Sensitivity100%Range:91.7 - 100Clinical Specificity92.4%Range:88.2- 92.41091AESKULISA SARS-CoV-2 NP IgA586Aesku.DiagnosticsGermanywww.aesku.comYesCommercialisedNoNoAutomatedManualAntibodyIgA Additional info: http://en.diagreat.com/Private/Files/20200402/6372142236666949104672720.pdf https://www.aesku.com/index.php/diagnostics/aeskulisa-elisa-test-kits/infectious-serology-elisa/item/3972021-05-10 13:04:00871Immuno-AntibodyYesImmunoassayQuantitativeMagnetic ElectrochemicalClinical Sensitivity98.3%Clinical Specificity99%1344SMARAPIDTEST650APLUS Diagnostics Laboratuvar San.Tic.A.S.Turkeywww.aplustbd.comYesCommercialisedNoNoCassetteLateral flowNear POC / POCAntibodyAntigenNasal swabSaliva2021-05-10 13:04:001111Immuno-AntigenYesNoImmunoassayQualitative15LOD15Fp52 out of 40 samples of Gold standard reagent Fn2.52 out of 80 samples of Gold standard reagent Accuracy96%Clinical Sensitivity95%1112Immuno-AntibodyYesNoImmunoassayQualitative15LOD0.10.1Calibrationnot evaluatedCrossreactivityevaluatedFp1.47%1 out of 68 samples of Gold standard reagent Fn10.1%10 out of 99 samples of Gold standard reagentPrecisionnot evaluatedAccuracy98% IgGAccuracy93% IgMReproducibilitynot evaluatedRobustnessevaluatedClinical Sensitivity97% IgGClinical Sensitivity87% IgM61339509-Sengenics High-throughput, High Multiplex Microtitre Assay231Sengenics Corporation Pte LtdUnited Stateswww.sengenics.com/NoCommercialisedNoNoAutomatedManualAntibodyAntigen2021-05-10 13:04:00509Immuno-AntibodyImmunoassay458Zugotech COVID-19 IgM/IgG Rapid Test295Zugotech Labs LtdGermanywww.zugotech-labs.com/NoIn developmentNoNoNear POC / POCAntibody2021-05-10 13:04:00383Immuno-AntibodyYesImmunoassay1058Xfold immunoassay578Xfold ImagingFinlandwww.xfoldimaging.com/NoCommercialisedNoNoAutomatedManualAntibodyNasal swabSaliva2021-05-10 13:04:00851Immuno-AntibodyImmunoassayQuantitativeFluorescenceImmunofluorescence15CalibrationEvaluatedPrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluated461Wondfo SARS-CoV-2 Antibody Test (lateral flow method)124Guangzhou Wondfo Biotech Co., LtdChinaen.wondfo.com.cn/YesCommercialisedNoNoLateral flowNear POC / POCAntibodyPlasmaWhole blood2021-05-10 13:04:00372Immuno-AntibodyYesNoImmunoassayQualitative15CrossreactivityEvaluatedReproducibilityEvaluatedClinical Sensitivity85.8%IgM+IgG82Wantai SARS-CoV-2 Ab Rapid Test49Beijing Wantai Biological Pharmacy Enterprise Co., LtdChinawww.ystwt.cn/NoCommercialisedNoNoNear POC / POCAntibody2021-05-10 13:04:0058Immuno-AntibodyYesImmunoassayNot foundRapid diagnostic test Not found Not found 590VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total356Ortho Clinical DiagnosticsUnited Stateswww.orthoclinicaldiagnostics.com/NoCommercialisedNoNoAutomatedManualAntibody2021-05-10 13:04:00480Immuno-AntibodyImmunoassay795VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG356Ortho Clinical DiagnosticsUnited Stateswww.orthoclinicaldiagnostics.com/NoCommercialisedNoNoLab-basedAntibody2021-05-10 13:04:00639Immuno-AntibodyImmunoassay484Viralert COVID-19 IgG/IgM Antibody Rapid Test Kit306Naturitious LLCUnited Stateswww.virconnect.com/NoCommercialisedNoNoNear POC / POCAntibodyWhole blood2021-05-10 13:04:00405Immuno-AntibodyYesImmunoassay20551Viral Transport Medium349Fjord Diagnostics SDNMalaysiawww.fjorddiagnostics.com/NoCommercialisedNoNoLab-basedAntibody2021-05-10 13:04:00467Immuno-AntibodyImmunoassayOther1478UNICELL-2019-nCoV NAb379SHENZHEN YHLO BIOTECH CO., LtdChinawww.szyhlo.comYesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2021-05-10 13:04:001227Immuno-AntibodyYesImmunoassayQualitative15LOD0AUCalibrationnot evaluatedCrossreactivitynot evaluatedPrecisionevaluatedReproducibilityevaluatedRobustnessnot evaluated698UBI SARS-CoV-2 ELISA426United BiomedicalUnited Stateswww.unitedbiomedical.comNoCommercialisedNoNoLab-basedAntibody2021-05-10 13:04:00582Immuno-AntibodyELISA9The non-invasive MEGA test of SARS-CoV-27Absea Biotechnology LtdChinawww.absea-antibody.com/NoIn developmentNoNoNear POC / POCAntibodyAMP Rapid Test SARS-CoV-2 Ag 2021-05-10 13:04:009Immuno-AntibodyYesImmunoassay259Test-it COVID-19 IgM/IgG Lateral Flow Assay162Lifeassay Diagnostics Pty LtdUnited Stateslifesadx.com/NoIn developmentNoNoNear POC / POCAntibody2021-05-10 13:04:00215Immuno-AntibodyYesImmunoassay399Telepoint Medical Services SARS-CoV-2 IgG/IgM Rapid Qualitative Test258Telepoint Medical Services LLCCanadawww.telepointofcare.com/NoCommercialisedNoNoNear POC / POCAntibody https://www.testlinecd.com/file/1580/COVID-19_AN_NEW%20(002).pdf?version=202008131535 2021-05-10 13:04:00322Immuno-AntibodyYesImmunoassayType of antigenCombination of selected parts of the specific antigens of SARS-CoV-2 (NCP, RBD, Spike S2, E, ACE2, PLPro protein) and antigens for exclusion cross-reactivity with other endemic coronaviruses (MERS-CoV, SARS-CoV, HCoV 229E Np, HCoV NL63 Np).316SureStatus COVID-19 (SARS-CoV-2) EIA Test206Premier Medical Corporation Pvt. LtdIndiawww.premiermedcorp.com/NoIn developmentNoNoAutomatedManualAntibody2021-05-10 13:04:00264Immuno-AntibodyImmunoassay317SureStatus COVID-19 (SARS-CoV-2) Card Test206Premier Medical Corporation Pvt. LtdIndiawww.premiermedcorp.com/NoIn developmentNoNoCardNear POC / POCAntibody2021-05-10 13:04:00265Immuno-AntibodyYesImmunoassay631Smart Test Covid-19 Vyttra375Vyttra DiagnosticosBrazilvyttra.com/NoCommercialisedNoNoNear POC / POCAntibody2021-05-10 13:04:00519Immuno-AntibodyYesImmunoassayType of antigennucleocapside protein1113SGT anti-SARS-CoV-2 total Ab ELISA261Sugentech, IncSouth Koreasugentech.com/YesCommercialisedNoNoAutomatedManualAntibody from website (Clinical Specificity: 99.0%; Clinical Sensitivity: 87.5% (vs. RT-PCR confirmed samples); Accuracy: 96.8%); "MATERIALS PROVIDED1. CoV-Check COVID-19 IgG/IgM Test Device (Kit Size: 25 Tests / Box)2. Sample Buffer (1 Bottle – 3.0 ml)3. 2 ?L Capillary Pipette (25 pipettes / Bag)4. Instructions for Use – 1LIMITATIONS1. CoV-Check COVID-19 IgG/IgM Test Device is limited to the qualitative detection of anti-2019-nCoV antibody levels in serum, plasma, or whole blood specimen. The exact concentration of anti-2019-nCoV antibody cannot be determined by this assay.2. Although the test is very accurate in detecting anti-2019-nCoV antibody, a low incidence of false results can occur. Other clinically available tests are required if questionable results are obtained.3. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.4. In the early stage of infection, if IgM and IgG antibodies are not produced or the titer is very low, false negative results will occur. It is recommended that patients should collect samples again after 7-14 days, and test both the previously collected sample and the latest sample at the same time and compare the results to confirm whether there is serological positive conversion or significant increase in titer. In the later stage of infection, IgM titer will decrease or even be negative, while IgG will continue to increase" 2021-05-10 13:04:00890Immuno-AntibodyNoYesELISA150Manual or automated 1152SETRO602Secutronic Technology Co.,LtdChinasecutronic.en.made-in-china.com/YesCommercialisedNoNoCassetteNear POC / POCAntibodyPlasmaSerumWhole blood https://secutronic.en.made-in-china.com/product-group/SqEneLFCnzVu/Rapid-Test-Kit-catalog-1.html2021-05-10 13:04:00924Immuno-AntibodyYesYesImmunoassayQualitative10Fp0%Fn3.12%Accuracy99%Clinical Sensitivity96.88%1624SCoV-2 DetectTM IgM ELISA271Viracor EurofinsUnited Stateswww.viracor-eurofins.com/clinical-diagnostics/NoCommercialisedNoNoLab-basedAntibodySerum2021-05-10 13:04:001304Immuno-AntibodyELISACrossreactivityAnti-Influenza A/B, Anti-Hepatitis B, Anti-Hepatitis C, Anti-Nuclear Antibody, Rheumatoid Factor, Human Anti-Mouse Antibody, Anti-HIV, Anti-Respiratory Syncytial Virus, Normal Human seraFp7.5%92.50% (111/120)Fn1.05%98.95% (94/95)Reproducibility13.3%CI95: 13.3-24.3%798ScheBo SARS-CoV-2 Quick359ScheBo Biotech AGGermanywww.schebo.de/YesCommercialisedNoNoCardAutomatedManualAntibodyWhole blood2021-05-10 13:04:00484Immuno-AntibodyNoImmunoassayQualitativeColorimetry15Clinical Sensitivity97.5% IgGClinical Sensitivity97.5% IgMClinical Specificity99.5% IgGClinical Specificity100% IgM379SARS-CoV-2 Tru-EIA248St. Petersburg Research Institute of Vaccines and Sera (FSUE SPbSRIVS FMBA)Russiawww.spbniivs.ru/business/catalog/NoIn developmentNoNoAutomatedManualAntibody2021-05-10 13:04:00311Immuno-AntibodyImmunoassayLOD10AU/mL137SARS-COV-2 Total Antibody ELISA Kit82Creative DiagnosticsUnited Stateswww.creative-diagnostics.com/NoCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2021-05-10 13:04:00102Immuno-AntibodyYesELISAQualitativeFluorescenceClinical Sensitivity98%Clinical Specificity98%660SARS-CoV-2 Total Antibody EIA403ImmyUnited Stateswww.immy.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2021-05-10 13:04:00553Immuno-AntibodyYesImmunoassayQualitativeFluorescence60Accuracy98%Clinical Sensitivity92%Clinical Specificity100%833SARS-CoV-2 Total Ab ELISA49Beijing Wantai Biological Pharmacy Enterprise Co., LtdChinawww.ystwt.cn/YesCommercialisedNoNoAutomatedManualAntibodySerum2021-05-10 13:04:00684Immuno-AntibodyNoYesELISAQualitativeFluorescence75Manual or automated Fluorescence Clinical Sensitivity94.36%Clinical Specificity100%1050SARS-CoV-2 Total Ab526DIALAB GmbHAustriawww.dialab.at/en/home/YesCommercialisedNoNoMicroplateLab-basedAntibodyPlasmaSerum2021-05-10 13:04:00822Immuno-AntibodyNoYesELISAQualitativeMagnetic Electrochemical70CrossreactivityEvaluatedClinical Sensitivity100%(15/15)Clinical Specificity99.52%(2927/2941)1049SARS-CoV-2 Total (COV2T) assay444Siemens HealthineersGermanywww.siemens-healthineers.comYesCommercialisedNoNoLab-basedAntibodyPlasmaSerum2021-05-10 13:04:00820Immuno-AntibodyImmunoassayQualitativeChemiluminescenceClinical Sensitivity98.1%CI: 96.6 - 99.1Clinical Specificity99.9%CI: 99.4 - 100488SARS-CoV-2 Specific IgM and IgG Test Kit (Coillodal Gold)310Tianjin Jianbo Biological Co., LtdChinawww.jianbobiology.com/en/NoCommercialisedNoNoNear POC / POCAntibody2021-05-10 13:04:00409Immuno-AntibodyYesImmunoassay221SARS-COV-2 specific antibody test kit (Immunochromatography)136Hunan Yonghe-Sun Biotechnology Co., LtdChinawww.yh-sun.com/NoCommercialisedNoNoNear POC / POCAntibody2021-05-10 13:04:00176Immuno-AntibodyImmunochromatographySample preparation501SARS-COV-2 Rapid Test318Pharmact (Berlin)Germanypharmact-health.comYesCommercialisedNoNoCardFingertipNear POC / POCAntibodyWhole blood2021-05-10 13:04:00420Immuno-AntibodyYesNoImmunoassayQualitative20FingertipAccuracy99% IgMAccuracy99.2% IgGClinical Sensitivity98.1% IgMClinical Sensitivity98.2% IgGClinical Specificity99.5% IgMClinical Specificity99.7% IgG421Immuno-AntibodyYesNoImmunoassayQualitative20Card Precision99% IgMPrecision99.2% IgGClinical Sensitivity98% IgMClinical Sensitivity98.2% IgGClinical Specificity99.5% IgMClinical Specificity99.7% IgG486SARS-CoV-2 Pseudovirus assay for Neutralizing Antibodies308RetroVirox IncUnited Statesretrovirox.com/NoIn developmentNoNoLab-basedAntibody2021-05-10 13:04:00407Immuno-AntibodyImmunoassay1922SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette(Whole Blood/Serum/Plasma)128Hangzhou Biotest Biotech Co., LtdChinaen.biotests.com.cnYesCommercialisedNoNoCassetteLateral flowNear POC / POCAntibodyPlasmaSerumVenous whole bloodWhole bloodWhole blood with anti-coagulantsA rapid test for the qualitative detection of neutralizing antibodies to SARSCoV-2 in whole blood, serum, or plasma. Competition method.2021-05-10 13:18:201598Immuno-AntibodyNoImmunoassayQualitativeNeutralization Antibody (NAb)15LOD0AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0%No false positive result is observed in 130 negative samplesFn1.53%2 false negative results are observed in 130 positive samplesPrecisionEvaluatedAccuracy99%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98%Clinical Specificity100%Type of antigenOther1921SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette (Whole Blood/Serum/Plasma)128Hangzhou Biotest Biotech Co., LtdChinaen.biotests.com.cnYesCommercialisedNoNoCassetteLateral flowNear POC / POCAntibodyPlasmaSerumVenous whole bloodWhole bloodWhole blood with anti-coagulantsA rapid test for the qualitative detection of neutralizing antibodies to SARS-CoV-2 in whole blood, serum, or plasma. Indirect method.2021-05-10 13:18:201597Immuno-AntibodyNoImmunoassayQualitativeNeutralization Antibody (NAb)10LOD0AUCalibrationNot evaluatedCrossreactivityEvaluatedFp1.92%2 false positive results are observed in 104 negative samplesFn0%No false negative result is observed in 152 positive samplesPrecisionEvaluatedAccuracy99%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%Clinical Specificity98%Type of antigenOther1757SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette ( Colloidal Gold Method)840Wuhan NanoDiagnosis for Health Biotechnology Co., LtdChinandh-biotech.comYesCommercialisedNoNoCassetteNear POC / POCAntibodyPlasmaSerumWhole bloodThis kit applied chromatographic immunoassay technology as a blocking detection tool. This kit is intended for the qualitative detection of SARS-CoV-2 neutralizing antibodies in human serum, plasma, or whole blood specimen. This kit is intended for use as an aid in identifying individuals with an adaptive immune response to vaccination or natural infection.2021-05-10 13:18:201435Immuno-AntibodyYesNoChromatographyQualitativeColorimetry15LOD0AUCalibrationNot EvaluatedCrossreactivityEvaluatedFp0AUFn0AUPrecisionEvaluatedAccuracy100%neutralizing antibodiesReproducibilityEvaluatedRobustnessNot EvaluatedClinical Sensitivity100%neutralizing antibodies2062SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette952Chinahttp://www.sejoy.com.cn/YesCommercialisedNoNoCassetteNear POC / POCAntibodyPlasmaSerumWhole bloodWe have also evaluated the cross reactivity and interference substances.2021-05-17 10:34:561742Immuno-AntibodyNoImmunoassayQualitativeSandwichOther15neutralizing antibodyLOD5050AUCalibrationNot evaluatedCrossreactivityEvaluatedFp3AUFn2AUPrecisionEvaluatedAccuracy98.97%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.4%Clinical Specificity99.2%Type of antigenOther1584SARS-CoV-2 Neutralizing Antibody Rapid Test455Assure Tech. (Hangzhou) Co., LtdChinawww.diareagent.com/YesCommercialisedNoNoCassetteNear POC / POCAntibodyPlasmaSerumWhole blood no info on website about preformance (LOD=0) 2021-05-10 13:04:001264Immuno-AntibodyYesYesImmunoassayQualitative15Rapid diagnostic test cassette LOD0CalibrationevaluatedCrossreactivityevaluatedFpNot availableFnNot availablePrecisionevaluatedAccuracy98.1%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity92.7%1840SARS-CoV-2 Neutralizing Antibody Rapid Test624Zhejiang Anji Saianfu Biotech Co., LtdChinawww.seinofy.comYesCommercialisedNoNoCassetteManualAntibodyPlasmaSerumWhole bloodsend email to us2021-05-10 13:18:201517Immuno-AntibodyImmunoassaySemiquantitativeNeutralization Antibody (NAb)15LOD0.25AUCalibrationEvaluatedCrossreactivityEvaluatedFp10%Fn5.5%PrecisionEvaluatedAccuracy92%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90%Clinical Specificity94.5%1953SARS-CoV-2 Neutralizing Antibody Kit (CLIA)168Maccura Biotechnology Co., LtdChinawww.maccura.com/enYesCommercialisedNoNoCartridgeAutomatedAntibodyPlasmaSerumFor in vitro detection of neutralizing antibodies against SARS-CoV-2 in human serum or plasma.2021-05-10 13:18:201629Immuno-AntibodyImmunoassayNeutralization Antibody (NAb)Other20LOD2AUCalibrationEvaluatedCrossreactivityEvaluatedFp2.7AUFn2.2AUPrecisionEvaluatedAccuracy97.8%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.3%Clinical Specificity98.2%Type of antigenOther1771SARS-CoV-2 Neutralizing Antibody Assay Kit (Immunochromatography)792Wuhan Life Origin Biotech Joint Stock Co., Ltd.Chinawww.szybio.comYesCommercialisedNoNoCardLateral flowNear POC / POCAntibodyPlasmaSerumWhole blood2021-05-10 13:04:001450Immuno-AntibodyYesYesImmunochromatographyQualitative15LOD0U/mlCrossreactivityEvaluatedFp1.56%(2/128),95% CI(0.19%-5.53%)Fn5.36%(3/56),95% CI(1.12%-14.87%)PrecisionEvaluatedRobustnessEvaluated1765SARS-CoV-2 Neutralizing Antibody Assay Kit (ELISA)792Wuhan Life Origin Biotech Joint Stock Co., Ltd.Chinawww.szybio.comYesCommercialisedNoNoManualAntibodyPlasmaSerum2021-05-10 13:04:001443Immuno-AntibodyYesELISAQualitative60LOD0AUCalibration0Fp1.14%Fn4.55%1816SARS-CoV-2 Neutralizing Antibodies Test Kit (Latex particle-enhanced turbidimetric immunoassay)824Shenzhen Kisshealth Biotechnology Co., LtdChinaen.kisshealth.cn/YesCommercialisedNoNoLatexManualAntibodySerum2021-05-10 13:04:001494Immuno-AntibodyImmunoassayNeutralization Antibody (NAb)10LOD0.5AUCalibrationNot evaluatedCrossreactivityEvaluatedFp1%≤1%Fn0%NonePrecisionEvaluatedAccuracy98.2%ReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity98.32%Clinical Specificity98.1%1885SARS-CoV-2 Neutralizing Antibodies Test862Xiamen Wiz Biotech Co., LtdChinawww.wizbiotech.comYesCommercialisedNoNoCardManualAntibodyPlasmaSerumWhole blood2021-05-10 13:04:001564Immuno-AntibodyImmunochromatographyQualitativeFluorescence15LOD0.3AUCalibrationEvaluatedCrossreactivityEvaluatedFp0.537 false positives were found in 1311 samples tested.Fn0.466 false negatives were found in 1311 samples tested.PrecisionEvaluatedAccuracy99.01%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.8%Clinical Specificity99.14%Type of antigenOther1708SARS-CoV-2 NAbs (CLIA)761MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.Chinawww.medcaptain.comYesCommercialisedNoNoCassetteAutomatedManualAntibodyPlasmaSerum2021-05-10 13:04:001388Immuno-AntibodyYesCLIAQuantitativeChemiluminescence25LOD3AUCalibrationevaluatedCrossreactivityevaluatedFp2.9%Fn0%PrecisionevaluatedAccuracy97.9%(Neutralizing Antibodies)ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity100%(Neutralizing Antibodies)364SARS-COV-2 IgM/IgG antibody test (Colloidal Gold)241ShanXi Medical UniversityChinawww.sxmu.net.cn/NoUnknownNoNoNear POC / POCAntibody2021-05-10 13:04:00304Immuno-AntibodyYesImmunoassay680SARS-CoV-2 IgM/IgG Antibody Rapid Test Kit417Nanjing Liming BioProducts Co., LtdChinawww.limingbio.comNoCommercialisedNoNoNear POC / POCAntibody2021-05-10 13:04:00572Immuno-AntibodyYesImmunoassayType of antigenantigen colloidal gold of SARS-CoV-2806SARS-CoV-2 IgM IgG Test Kit (Colloidal Gold)469Shenzhen GeneBioHealth Co., LtdChinawww.genebiohealth.com/en/NoCommercialisedNoNoCassetteLab-basedAntibodyWhole blood2021-05-10 13:04:00649Immuno-AntibodyYesNoImmunoassayQualitative10139SARS-CoV-2 IgM ELISA Kit82Creative DiagnosticsUnited Stateswww.creative-diagnostics.com/NoCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2021-05-10 13:04:00104Immuno-AntibodyELISAQualitativeFluorescenceClinical Sensitivity98%Clinical Specificity98%696SARS-CoV-2 IgG/IgM Rapid Test Cassette424Suzhou Kangheshun Medical TechnologyChinawww.junkangmedical.com/NoCommercialisedNoNoNear POC / POCAntibodyhttps://www.quidel.com/sites/default/files/product/documents/EF1438903EN00.pdf; 2021-05-10 13:04:00580Immuno-AntibodyYesImmunoassayNot found1622SARS-CoV-2 IgG ELISA Test Kit271Viracor EurofinsUnited Stateswww.viracor-eurofins.com/clinical-diagnostics/NoCommercialisedNoNoLab-basedAntibodySerum2021-05-10 13:04:001302Immuno-AntibodyELISACrossreactivityAdenovirus, Parainfluenza virus, Influenza A, Influenza B, Enterovirus, Respiratory syncytial virus, Chlamydia pneumoniae, Haemophilus influenza, Legionella pneumophila, Bordetella pertussis, Mycoplasma pneumoniae, Candida albicansClinical Sensitivity100%138SARS-CoV-2 IgG ELISA Kit82Creative DiagnosticsUnited Stateswww.creative-diagnostics.com/NoCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2021-05-10 13:04:00103Immuno-AntibodyELISAQualitativeFluorescenceClinical Sensitivity98%Clinical Specificity98%378SARS-CoV-2 IgG antibody test kit SARS-CoV-2 IgM antibody test (automated)247Sophonix Co., LtdChinaen.sophonix.net/NoCommercialisedNoNoAutomatedManualAntibody2021-05-10 13:04:00310Immuno-AntibodyImmunoassay193SARS-CoV-2 Direct Test447Vela DiagnosticsSingaporewww.veladx.com/NoIn developmentNoNoNear POC / POCAntibody2021-05-10 13:18:20149Immuno-AntibodyYesImmunoassay990SARS-CoV-2 Antibody Test strip (colloidal Gold Method)528SinocareChinawww.sinocareintl.comYesCommercialisedNoNoLateral flowNear POC / POCAntibodyWhole blood2021-05-10 13:04:00769Immuno-AntibodyYesNoImmunoassayQualitative20Clinical Sensitivity95%CI: 95-96.3Clinical Specificity99.2%CI: 99.2-99.6460SARS-CoV-2 Antibody Test Strip498Changsha Sinocare, IncChinawww.sinocare.com/web/about/index_enYesCommercialisedNoNoCassetteNear POC / POCAntibodyWhole blood2021-05-10 13:04:00708Immuno-AntibodyYesNoImmunoassayQualitativeColloidal gold20Precision90%Reproducibility100%Clinical Sensitivity95%Clinical Specificity98.3%523SARS-CoV-2 Antibody Test (colloidal gold immunochromatography)319Beijing Lepu Medical Technology Co., LtdChinaen.lepumedical.com/YesCommercialisedNoNoStripNear POC / POCAntibodyPlasmaSerum2021-05-10 13:04:00423Immuno-AntibodyYesImmunochromatographyColloidal goldLOD3.1U/ml778SARS-COV-2 Antibody Test467Biosino Bio-Technology and Science IncChinawww.sinobio.com.cn/YesCommercialisedNoNoLab-basedAntibody2021-05-10 13:04:00646Immuno-AntibodyImmunoassay310SARS-CoV-2 Antibody Detection Kit (Colloidal Gold Immunochromatographic assay)204PerGrande BioTech Development Co., LtdChinawww.pergrande.com.cn/YesCommercialisedNoNoNear POC / POCAntibody2021-05-10 13:04:00262Immuno-AntibodyYesImmunochromatographyColorimetry641SARS-CoV-2 antibody assay142Innovita Biological TechnologyChinawww.innovita.com.cn/NoCommercialisedNoNoNear POC / POCAntibody2021-05-10 13:04:00530Immuno-AntibodyYesImmunoassay1018SARS-CoV-2 Antibody147InTec Products, IncChinawww.intecasi.com/YesCommercialisedNoNoNear POC / POCAntibody2021-05-10 13:04:00813Immuno-AntibodyYesImmunoassay1817SARS-CoV-2 Antibodies Test Kit (Latex particle-enhanced turbidimetric immunoassay)824Shenzhen Kisshealth Biotechnology Co., LtdChinaen.kisshealth.cn/YesCommercialisedNoNoLatexManualAntibodySerum2021-05-10 13:04:001495Immuno-AntibodyImmunoassay10LOD0.5AUCalibrationNot evaluatedCrossreactivityEvaluatedFp1%≤1%Fn0%NonePrecisionEvaluatedAccuracy96.79%ReproducibilityNot evaluatedRobustnessEvaluatedClinical Sensitivity96.25%Clinical Specificity97.37%562SARS-CoV-2 (COVID-19) spike antibody (GTX135360)_ELISA353GeneTex International CorporationUnited Stateswww.genetex.com/NoCommercialisedNoNoAutomatedManualAntibody2021-05-10 13:04:00477Immuno-AntibodyELISA1427SARS-CoV-2 (COVID-19) serological test671ALIMETRIX, INC.United Stateswww.alimetrix.com/NoIn developmentNoNoLab-basedAntibodySerum https://www.alimetrix.com/images/Alimetrix-COVID-19.pdf2021-05-10 13:04:001186Immuno-AntibodyImmunoassayQuantitativeMicroarray microarray 560SARS-CoV-2 (COVID-19) nucleocapsid antibody (GTX135357)_ELISA353GeneTex International CorporationUnited Stateswww.genetex.com/NoCommercialisedNoNoAutomatedManualAntibody2021-05-10 13:04:00475Immuno-AntibodyELISA135SARS-CoV-2 (2019-nCoV) Spike Protein ELISA Kit75Creative BiolabsUnited Statessars-cov-2.creative-biolabs.com/NoCommercialisedNoNoManualAntibody Microarray based method 2021-05-10 13:04:0094Immuno-AntibodyELISAQualitativeAbsorbance136SARS-CoV-2 (2019-nCoV) Nucleoprotein Protein ELISA Kit75Creative BiolabsUnited Statessars-cov-2.creative-biolabs.com/NoCommercialisedNoNoManualAntibody2021-05-10 13:04:0095Immuno-AntibodyELISAQualitativeAbsorbance547SARS-CoV-2 (2019-nCoV) IgG/IgM Lateral Flow Assay Kit (Whole Blood/ Serum/ Plasma)335ElabscienceUnited Stateswww.elabscience.com/NoCommercialisedNoNoFingertipLateral flowAutomatedManualAntibodyPlasmaSerumWhole blood2021-05-10 13:04:00463Immuno-AntibodyYesNoImmunoassayQualitative10Clinical Sensitivity98.81%Clinical Specificity98.02%559SARS-CoV / SARS-CoV-2 (COVID-19) spike antibody [1A9] (GTX632604)353GeneTex International CorporationUnited Stateswww.genetex.com/NoCommercialisedNoNoAutomatedManualAntibody2021-05-10 13:04:00474Immuno-AntibodyImmunoassay558SARS-CoV / SARS-CoV-2 (COVID-19) nucleocapsid antibody [6H3] (GTX632269)_ELISA353GeneTex International CorporationUnited Stateswww.genetex.com/NoCommercialisedNoNoAutomatedManualAntibody2021-05-10 13:04:00473Immuno-AntibodyELISA1030SARS CoV-2 IgG/IgM Rapid Test541Tersaco AGSwitzerlandtersaco.ch/NoCommercialisedNoNoLateral flowNear POC / POCAntibodyWhole blood https://www.testlinecd.com/file/1580/COVID-19_AN_NEW%20(002).pdf?version=202008131535 I could not find CE-IVD proof2021-05-10 13:04:00784Immuno-AntibodyYesNoImmunoassayQualitative10Clinical Sensitivity95.9% IgMClinical Sensitivity96.5% IgGClinical Specificity97.7% IgMClinical Specificity98% IgGType of antigen combination of selected parts of the specific antigens of SARS-CoV-2 (NCP, RBD, Spike S2, E, ACE2, PLPro protein) and antigens for exclusion cross-reactivity with other endemic coronaviruses (MERS-CoV, SARS-CoV, HCoV 229E Np, HCoV NL63 Np).445ReSARS Pan-Corona Rapid Test281Zalgen Labs, LLCUnited Stateswww.zalgen.com/NoIn developmentNoNoAutomatedManualAntibody2021-05-10 13:04:00357Immuno-AntibodyImmunoassay450ReSARS Pan-Corona IgM ELISA Kit281Zalgen Labs, LLCUnited Stateswww.zalgen.com/NoIn developmentNoNoAutomatedManualAntibody2021-05-10 13:04:00364Immuno-AntibodyELISA601Rapid test for IgM/IgG antibodies against SARS-COV-2363Rapid Bio LLCUnited Statesrapidbiosystems.com/NoCommercialisedNoNoNear POC / POCAntibody2021-05-10 13:04:00488Immuno-AntibodyYesImmunoassayType of antigenrecombinant SARS-CoV-2 antigens228Rapid SARS-CoV-2 Antibody Test147InTec Products, IncChinawww.intecasi.com/YesCommercialisedNoNoNear POC / POCAntibodyWhole blood2021-05-10 13:04:00189Immuno-AntibodyYesNoImmunoassayQualitativeRapid diagnostic test Fingertip Not found 1904Rapid New Coronavirus (COVID19) Neutralizing Antibody Test806Immunospark s.r.l.Italywww.immunospark.comYesCommercialisedNoNoCassetteManualNear POC / POCAntibodyPeripheral bloodPlasmaSerumWhole bloodcompetitive assay that provide a multiple interpretatino of the protection level2021-05-10 13:04:001580Immuno-AntibodyNoImmunochromatographyQualitativeNeutralization Antibody (NAb)Other10Colloidal Gold detectionLOD40AUCalibrationEvaluatedCrossreactivityEvaluatedFpA smal amount of results did not correltaed with the reference but correlated with rapid testFnA smal amount of results did not correltaed with the reference but correlated with rapid testPrecisionEvaluatedAccuracy99%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93%Clinical Specificity99%Type of antigenOther297Rapid COVID-19 (SARS-CoV-2) IgM/IgG Antibody Detection Kit188Nirmidas Biotech, IncUnited Stateswww.nirmidas.com/NoCommercialisedNoNoAutomatedManualAntibody2021-05-10 13:04:00245Immuno-AntibodyImmunoassay780QuickNavi-COVID19468Denka Seiken Co. LtdJapandenka-seiken.com/NoIn developmentNoNoLab-basedAntibody2021-05-10 13:04:00648Immuno-AntibodyImmunoassay Not found Not found 756Platelia SARS-CoV-2 Total Ab Assay332Bio-Rad Laboratories, IncUnited Stateswww.bio-rad.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2021-05-10 13:04:00612Immuno-AntibodyYesImmunoassayQualitativeSandwich, DoubleMCrossreactivityEvaluatedPrecisionEvaluatedReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity86.5%(73-100)Clinical Specificity100%320P4DETECT COVID-19 IgM/IgG208PRIME4DIA Co., LtdSouth Koreawww.prime4dia.com/NoCommercialisedNoNoNear POC / POCAntibody2021-05-10 13:04:00268Immuno-AntibodyYesImmunoassay811Oy SARSPLEX482TeztedFinlandwww.tezted.com/YesCommercialisedNoNoAutomatedManualAntibodySerum2021-05-10 13:04:00669Immuno-AntibodyYesImmunoassayQualitativeFluorescenceClinical Sensitivity100%Clinical Specificity100%1422OPTI SARS-CoV-2 Total Antibody Test Kit668OPTI Medical SystemsUnited Stateswww.optimedical.comYesCommercialisedNoNoLab-basedAntibodyPlasmaSerum2021-05-10 13:04:001182Immuno-AntibodyYesImmunoassayQualitativeMagnetic Electrochemical90Clinical Sensitivity96.1%Clinical Specificity98%676One Step SARS-nCoV2 (COVID-19) IgG/IgM test131Hangzhou Testsea Biotechnology Co., LtdChinawww.testsealabs.com/NoIn developmentNoNoCassetteLab-basedAntibodyWhole blood2021-05-10 13:04:00805Immuno-AntibodyNoImmunoassayQualitativeColloidal gold5Accuracy94%Clinical Sensitivity88%1426OmniPATH COVID-19 Total Antibody ELISA Test260Thermo Fisher ScientificUnited Stateswww.thermofisher.com/ch/en/home.htmlYesCommercialisedNoNoLab-basedAntibodySerum https://www.fda.gov/media/142700/download2021-05-10 13:04:001185Immuno-AntibodyYesELISAQualitativeMagnetic Electrochemical90Clinical Sensitivity96.7%Clinical Specificity97.5%Type of antigeneceptor binding domain (RBD) of the S1 subunit of the spike (S) protein1021Novel Coronavirus(COVID-19) Test607MR HealthcareHong Kong S.A.Rwww.mr-healthcare.com/YesCommercialisedNoNoCassetteNear POC / POCAntibodyWhole blood2021-05-10 13:04:00933Immuno-AntibodyYesNoImmunoassayQualitative152040Novel Coronavirus Neutralizing Antibody Rapid Test Kit940Sensing Self Pte. Ltd.Singaporewww.sensingself.meYesCommercialisedNoNoCardCassetteLateral flowManualAntibodyPlasmaSerumWhole bloodThe Novel Coronavirus Neutralizing Antibody Rapid Test Kit is a qualitative product, not applicable to LOD2021-05-10 13:04:001718Immuno-AntibodyNoImmunochromatographyQualitativeNeutralization Antibody (NAb)10LOD0AUCalibrationEvaluatedCrossreactivityEvaluatedFp0%(377 samples are proven negative of 377 negative specimens)Fn1.37%(2 samples are proven negative of 144 positive specimens.PrecisionEvaluatedAccuracy99.62%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.63%Clinical Specificity99.99%Type of antigenOther1896Novel coronavirus neutralizing antibody Rapid Test Device344Hangzhou Realy Tech Co., LtdChinawww.realytech.com/YesCommercialisedNoNoCassetteNear POC / POCAntibodyPlasmaSerumWhole bloodThe Novel coronavirus neutralizing antibody Rapid Test Device is a qualitative product, not applicable to LOD.2021-05-10 13:04:001573Immuno-AntibodyNoImmunoassayQualitativeColorimetryValidity test kit10LOD0AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0%371 samples are proven negative of 371 negative specimens，so the false positive percentage is 0%.Fn5.27%144 samples are proven negative of 152 positive specimens，so the false negative percentage is 5.26%.PrecisionEvaluatedAccuracy98.47%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity94.73%Clinical Specificity99.9%99.9)]]>1802Novel Coronavirus Neutralizing Antibody Assay Reagent Kit344Hangzhou Realy Tech Co., LtdChinawww.realytech.com/YesCommercialisedNoNoCardNear POC / POCAntibody2021-05-10 13:04:001481Immuno-AntibodyNoYesImmunoassayQualitativeNeutralization Antibody (NAb)40LOD0AUCalibrationEvaluatedCrossreactivityEvaluatedFp0.44%228 samples are proven negative of 229 negative specimens.Fn0%120 samples are proven negative of 120 positive specimens.PrecisionEvaluatedAccuracy99.71%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.9%Clinical Specificity99.56%1636Novel Coronavirus COVID-19 IgM/IgG Test Kit (colloidal gold)732H-GuardChinawww.h-guard.com.cnNoCommercialisedNoNoNear POC / POCAntibody2021-05-10 13:04:001316Immuno-AntibodyYesImmunoassayColloidal gold10198Novel Coronavirus 2019-nCoV IgG Antibody Detection Kit (Colloidal Gold Method)116Guangzhou Darui Biotechnology Co.,LtdChinawww.daruibiotech.com/NoCommercialisedNoNoNear POC / POCAntibody2021-05-10 13:04:00155Immuno-AntibodyYesImmunoassayColloidal gold2045Novel Coronavirus (SARS-CoV-2) Neutralizing Antibody Detection Kit (Competitive ELISA)943Beijing Bohui Innovative Biotechnology Co., Ltd.Chinahttp://www.bohui-tech.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerumWhole bloodWe have CE marking, registered in Spanien. The products was registered in Spanish MOH with number RPS/515/2021.2021-05-10 13:04:001723Immuno-AntibodyELISANeutralization Antibody (NAb)120LOD20AUCalibrationEvaluatedCrossreactivityEvaluatedFp2.4%Serum：5/208;Fp0.98%Plama:2/203Fp1.94%Whole blood:4/206Fn0.49%Whole blood:2/411Fn0.72%Plama:3/414Fn0.24%Serum：1/409;PrecisionEvaluatedAccuracy98%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99.51Serum:(95%CI：97.28%~99.91%) Clinical Sensitivity98.53Plasma:95%CI：95.77%~99.50%)Clinical Sensitivity99.02Whole blood:(95%CI：96.50%~99.73%)Clinical Specificity99.03Whole blood:(95%CI：97.54%~99.62%)Clinical Specificity99.52Plasma:(95%CI：98.25%~99.87%)Clinical Specificity98.79Serum: (95%CI：97.20%~99.48%)Type of antigenOther2047Novel Coronavirus (SARS-CoV-2) Neutralizing Antibodies Test (Quantum Dots Fluorescence Immunoassay)943Beijing Bohui Innovative Biotechnology Co., Ltd.Chinahttp://www.bohui-tech.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerumWhole bloodWe have CE marking, registered in Spanien. The products was registered in Spanish MOH with number RPS/294/2021.2021-05-10 13:04:001725Immuno-AntibodyImmunochromatographyNeutralization Antibody (NAb)Fluorescence15LOD20AUCalibrationEvaluatedCrossreactivityEvaluatedFp1.95%Serum：4/205Fp1.47%Whole blood:3/204Fp0.98%Plasma:2/204Fn0.73%Serum：3/412Fn0.48%Plasma:2/413Fn0.72%Whole blood:3/413PrecisionEvaluatedAccuracy97%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.53%Whole blood: (95% CI: 95.77%~99.50%)Clinical Sensitivity99.02%Plasma:(95% CI: 96.50%~99.73%) Clinical Sensitivity98.53%Serum: (95% CI: 95.77%~99.50%) Clinical Specificity99.52%Plasma: (95% CI: 98.25%~99.87%). Clinical Specificity99.27%Whole blood: (95% CI:97.89%~99.75%)Clinical Specificity99.03%Serum: (95% CI:97.54%~99.62%) Type of antigenOther2048Novel Coronavirus (SARS-CoV-2) Neutralizing Antibodies Test (Double Antigen Sandwich Colloidal Gold Immunochromatography)943Beijing Bohui Innovative Biotechnology Co., Ltd.Chinahttp://www.bohui-tech.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerumWhole bloodWe have CE marking, registered in Spanien. The products was registered in Spanish MOH with number RPS/803/2021.2021-05-10 13:04:001726Immuno-AntibodyImmunochromatographyNeutralization Antibody (NAb)Colloidal gold15LOD20AUCalibrationEvaluatedCrossreactivityEvaluatedFp1.76%Serum: 6/340Fp2.06%Whole blood:7/339Fp1.19%Plasma: 4/337Fn1.04%Serum: 5/477Fn1.25%Plasma: 6/480Fn1.46%Whole blood:7/478PrecisionEvaluatedAccuracy99%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.94%Whole blood:(95%CI：95.80%~99.00%)Clinical Sensitivity98.23%Plasma:(95%CI：96.19%~99.19%) Clinical Sensitivity98.53%Serum: (95%CI：96.59%~99.37%) Clinical Specificity99.16%Plasma:(95%CI：97.87%~99.67%). Clinical Specificity98.54%Whole blood: (95%CI：97.01%~99.29%).Clinical Specificity98.74%Serum: (95%CI：97.29%~99.42%) . Type of antigenOther2044Novel Coronavirus (SARS-CoV-2) Neutralizing Antibodies Test (Colloidal Gold)943Beijing Bohui Innovative Biotechnology Co., Ltd.Chinahttp://www.bohui-tech.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerumWhole bloodWe have CE marking, registered in Spanien. The products was registered in Spanish MOH with number RPS/294/2021.2021-05-10 13:04:001722Immuno-AntibodyImmunochromatographyNeutralization Antibody (NAb)Colloidal gold15LOD20AUCalibrationEvaluatedCrossreactivityEvaluatedFp3.41%serum:7/205Fp1.94%whoreblood:5/257Fp2.67%plasma:7/262Fn1.45%serum:6/412Fn1.81%plama:8/440Fn2.47%whoreblood(11/445)PrecisionEvaluatedAccuracy98%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity95.82whoreblood: (95%CI: 92.67%-97.65%)Clinical Sensitivity96.96plasma: (95%CI: 94.11%-98.45%)Clinical Sensitivity97.06%serum:(95%CI: 93.73-98.65%)Clinical Specificity98.41plasma:(95% CI: 96.75%~99.23%)Clinical Specificity98.86whoreblood: (95% CI: 97.36%~99.51%).Clinical Specificity98.31%serum (95% CI:96.54%~99.18%)Type of antigen%Other47Novel Coronavirus (2019-nCov)Antibody IgG/IgM Assay Kit (Colloidal Gold)30Avioq Bio-Tech Co., LtdChinawww.avioqbio.com/NoCommercialisedNoNoNear POC / POCAntibody2021-05-10 13:04:0035Immuno-AntibodyYesImmunoassayColloidal gold1185Novegent COVID-19 Antibodies Rapid Test Kit620Chongqing Novegent Biotech Company LimitedChinawww.novegent.cnYesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerumWhole blood2021-05-10 13:04:00969Immuno-AntibodyYesNoImmunoassayQuantitativeColorimetry15Rapid diagnostic test Colloidal Gold Analytical Sensitivity96% IgMAccuracy95.5% IgGAccuracy95.5% IgMClinical Sensitivity96% IgG819NovaLisa SARS-CoV-2 (COVID-19)368NovaTec Immundiagnostica GmbHGermanywww.novatec-id.com/YesCommercialisedNoNoAutomatedManualAntibodySerum2021-05-10 13:04:00675Immuno-AntibodyYesImmunoassayQualitativeFluorescence105Clinical Sensitivity88.9%Clinical Specificity98.3%Type of antigenRecombinant angen284nCoVSENSe: IgM/ IgG test for spike and N-protein of SARS-CoV 2 (manual)178Module Innovations Private LtdIndiamoduleinnovations.com/NoIn developmentNoNoAutomatedManualAntibody2021-05-10 13:04:00235Immuno-AntibodyImmunoassay683NanoMedicina SARS-CoV-2 IgM/IgG Antibody Rapid Test419NanoResearchUnited Stateswww.nanoresearchinc.comNoCommercialisedNoNoNear POC / POCAntibody2021-05-10 13:04:00574Immuno-AntibodyYesImmunoassay401Multiplex detection and differentiation SARS-Cov-2 Serology Assay (manual)259Tetracore IncUnited Stateswww.tetracore.com/NoCommercialisedNoNoAutomatedManualAntibody https://www.trivitron.com/uploads/brochure/15967962524COVIDscreen_Plus_ELISA_Kit_Updated_V.07.pdf 2021-05-10 13:04:00323Immuno-AntibodyImmunoassay600MosaiQ COVID-19 Antibody Microarray369Quotient Limited SAUnited Kingdomquotientbd.com/covid-19YesCommercialisedNoNoBiochipAutomatedManualAntibodyWhole blood Data provided by the Manufacturer 2021-05-10 13:04:00508Immuno-AntibodyYesImmunoassayQualitativeMicroarray35Clinical Sensitivity100%Clinical Specificity99.8%Type of antigenS1 and S2 proteins287Mologic COVID-19 Rapid Test180Mologic LtdUnited Kingdommologic.co.uk/NoIn developmentNoNoNear POC / POCAntibody2021-05-10 13:04:00237Immuno-AntibodyYesImmunoassay997mö-screen 2019-NCOV Corona Virus Test532möLabGermanywww.moelab.de/startseite.htmlYesCommercialisedNoNoCassetteNear POC / POCAntibodyWhole blood2021-05-10 13:04:00774Immuno-AntibodyYesNoImmunoassayQualitative10CrossreactivityEvaluatedAccuracy99.4% IgGAccuracy97.6% IgMClinical Sensitivity99.9% IgGClinical Sensitivity91.8% IgMClinical Specificity99.5% IgGClinical Specificity99.2% IgM1491MAGLUMI SARS-CoV-2 Neutralizing Antibody (CLIA)255Snibe Co., LtdChinawww.snibe.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2021-05-10 13:04:001241Immuno-AntibodyYesCLIAQualitativeChemiluminescence30LOD0AUCalibrationevaluatedCrossreactivityevaluatedFp0%Fn0%PrecisionevaluatedAccuracy100%(93.69-100.00) % determined by testing 57 samples confirmed SARS-CoV-2 VNT50 ? 20ReproducibilityevaluatedRobustnessnot evaluatedClinical Sensitivity100%(93.69-100.00) % determined by testing 57 samples confirmed SARS-CoV-2 VNT50 ? 201112Kewei COVID-19 total antibody rapid test43Beijing Kewei Clinical Diagnostic Reagent IncChinaen.keweidiagnostic.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerumWhole blood http://en.keweidiagnostic.com/uploadfile/2020/0704/20200704024137750.pdf2021-05-10 13:04:00389Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry10Manual or automated Colloidal Gold Clinical Sensitivity93.33%Clinical Specificity99.6%1111Kewei COVID-19 total antibody ELISA Test Kit43Beijing Kewei Clinical Diagnostic Reagent IncChinaen.keweidiagnostic.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2021-05-10 13:04:00367Immuno-AntibodyNoYesELISAQualitativeSandwich, Double60Manual or automated microtiter plate Sandwich, Double Accuracy96%Clinical Sensitivity94.71%Clinical Specificity99.6%242KDx COVID-19 IgG/IgM Rapid Detection Test Kit149Kephera DiagnosticsUnited Stateswww.kephera.com/NoIn developmentNoNoNear POC / POCAntibody2021-05-10 13:04:00192Immuno-AntibodyYesImmunoassay243KDx COVID-19 IgG and IgM ELISA (manual)149Kephera DiagnosticsUnited Stateswww.kephera.com/NoIn developmentNoNoLab-basedAntibody2021-05-10 13:04:00193Immuno-AntibodyELISA958Instant-view PLUS COVID-19 Test17Alfa Scientific Designs IncUnited Stateswww.alfascientific.com/YesCommercialisedNoNoStripNear POC / POCAntibodyWhole blood2021-05-10 13:04:00754Immuno-AntibodyYesNoImmunoassayQualitative7CrossreactivityEvaluatedAccuracy96.7%131Instant COVID-19 “Coronavirus” Test418Confirm BioscienceUnited Stateswww.confirmbiosciences.com/YesCommercialisedNoNoNear POC / POCAntibodyWhole blood2021-05-10 13:04:00573Immuno-AntibodyYesNoImmunoassayQualitative15Rapid diagnostic test cassette Not found 1682INGEZIM Covid 19 CROM445EurofinsHungarywww.eurofins-technologies.com/YesCommercialisedNoNoLateral flowNear POC / POCAntibodyPlasmaSerumWhole blood2021-05-10 13:18:201361Immuno-AntibodyYesNoImmunoassayQualitative15LOD0AUCalibrationevaluatedCrossreactivityevaluatedFp1%Fn5%PrecisionevaluatedAccuracy96%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity94.5%Type of antigennucleoprotein699IgG/IgM Antibody Rapid Test Kits (Colloidal Gold Immunochromatography method)833Zhengzhou Fortune Bioscience Co., LtdChinawww.fortunetest.comNoCommercialisedNoNoNear POC / POCAntibody2021-05-10 13:18:20583Immuno-AntibodyYesImmunochromatography1477iFlash-2019-nCoV NAb379SHENZHEN YHLO BIOTECH CO., LtdChinawww.szyhlo.comYesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2021-05-10 13:04:001226Immuno-AntibodyYesImmunoassayQualitativeNeutralization Antibody (NAb)LOD-1AUCalibrationevaluatedCrossreactivityevaluatedPrecisionevaluatedReproducibilityevaluatedRobustnessnot evaluated253Human SARS-CoV-2 (Covid-19) Qualitative ELISA (manual)153KRISHGEN BioSystemsUnited Stateswww.krishgen.com/NoCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2021-05-10 13:04:00204Immuno-AntibodyYesELISAQualitativeSandwich120LODEvaluatedPrecisionEvaluated251Human Anti-SARS-CoV-2 (Covid-19) Spike Protein IgG ELISA (manual)153KRISHGEN BioSystemsUnited Stateswww.krishgen.com/NoCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2021-05-10 13:04:00203Immuno-AntibodyYesELISAQualitativeSandwich120LODEvaluatedPrecisionEvaluated249Human Anti-SARS-CoV-2 (Covid-19) Nucleocapsid Protein IgG ELISA (manual)153KRISHGEN BioSystemsUnited Stateswww.krishgen.com/NoCommercialisedNoNoAutomatedManualAntibody2021-05-10 13:04:00201Immuno-AntibodyELISA247Human Anti-SARS-CoV-2 (Covid-19) IgM Rapid Test153KRISHGEN BioSystemsUnited Stateswww.krishgen.com/NoCommercialisedNoNoNear POC / POCAntibody2021-05-10 13:04:00199Immuno-AntibodyYesImmunoassay315HR-PreV205Predigen IncUnited Stateswww.predigen.com/NoIn developmentNoNoNear POC / POCAntibody2021-05-10 13:04:00263Immuno-AntibodyYesImmunoassay813Great Basin System SARS-CoV-2 Direct Test447Vela DiagnosticsSingaporewww.veladx.com/NoIn developmentNoNoLab-basedAntibody Assay Features: Separate detection of IgG, IgM and IgA antibodies. Variable Cut off setting in IgG to increase the diagnostic value in different prevalence situations. Advantages of the VIROTECH reagent system. Compatible with diverse open platform ELISA analyzers 2021-05-10 13:04:00655Immuno-AntibodyImmunoassay120Type of antigennucleoprotein1701GLINE-2019-nCoV NAb379SHENZHEN YHLO BIOTECH CO., LtdChinawww.szyhlo.comYesCommercialisedNoNoCardAutomatedManualAntibodyPlasmaSerumWhole blood2021-05-10 13:04:001381Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15LOD10AUCalibrationevaluatedCrossreactivityevaluatedFp0AUFn0AUPrecisionevaluatedReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity100%5/51826GenSure COVID-19 Neutralizing Antibody Test (Fluorescence)340GenSure Biotech IncChinawww.gensbio.com/YesCommercialisedNoNoManualAntibody2021-05-10 13:18:201503Immuno-AntibodyImmunoassayNeutralization Antibody (NAb)15LODEvaluatedCalibrationNot evaluatedCrossreactivityEvaluatedPrecisionEvaluatedReproducibilityNot evaluatedRobustnessNot evaluated1586GB SARS-CoV-2 Ab ELISA104General Biologicals CorporationTaiwan ROCwww.gbc.com.tw/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2021-05-10 13:04:001266Immuno-AntibodyNoYesELISAQualitative120LOD0.089AUCalibrationnot evaluatedCrossreactivityevaluatedFp0%Fn1.92%PrecisionevaluatedAccuracy98.75%(Total antibody)ReproducibilityevaluatedRobustnessnot evaluatedClinical Sensitivity100%(Total antibody)Type of antigennucleoprotein1418FREND COVID-19 total Ab354NanoEntekSouth Koreawww.nanoentek.comNoCommercialisedNoNoCartridgeNear POC / POCAntibodyPlasma http://www.nanoentek.com/theme/nanont2_en/shop/02/product01_view.php?it_id=16020498012021-05-10 13:04:001179Immuno-AntibodyYesYesImmunoassayQualitativeFluorescence3Crossreactivity0% for tested agentsClinical Sensitivity96.7%IgG, IGM combinedClinical Specificity98.8%IgG, IgM combinedType of antigenSARS-CoV-2Nucleocapsid1411FREND COVID-19 SP354NanoEntekSouth Koreawww.nanoentek.comYesCommercialisedNoNoCartridgeNear POC / POCAntibodyPlasmaSerum http://www.nanoentek.com/theme/nanont2_en/shop/02/product01_view.php?it_id=15996404982021-05-10 13:04:001174Immuno-AntibodyYesImmunoassayQualitativeFluorescence3Crossreactivity0%for tested agentsClinical Sensitivity97.06%Clinical Specificity96.3%Type of antigenspike protein820Fosun COVID-19 IgG/IgM Rapid Antibody Detection Kit236Shanghai Fosun Long March Medical Science Co., LtdChinaen.lm-diagnostics.com.cn/NoCommercialisedNoNoNear POC / POCAntibody https://www.woerner-medizinprodukte.de/img/downloads/pdf/Infomaterial_280022.pdf 2021-05-10 13:04:00676Immuno-AntibodyYesImmunoassay206Finecare SARS-CoV-2 Antibody Test124Guangzhou Wondfo Biotech Co., LtdChinaen.wondfo.com.cn/YesCommercialisedNoNoNear POC / POCAntibodyWhole blood2021-05-10 13:04:00163Immuno-AntibodyYesYesImmunoassayQualitativeFluorescenceRapid diagnostic test chip fluorescence 240Fast SARS-CoV-2 lgM/lgG Antibody Detection Kit (Colloidal Gold)152Jiangsu Superbio Biomedical Technology (Nanjing) Co., LtdChinawww.superbio.cn/NoCommercialisedNoNoCardNear POC / POCAntibodyWhole blood2021-05-10 13:04:00198Immuno-AntibodyYesNoImmunoassayQualitativeColloidal gold314EyeRa-Covid203Prantae Solutions Pte LtdIndiawww.prantae.solutions/NoIn developmentNoNoNear POC / POCAntibody2021-05-10 13:04:00261Immuno-AntibodyYesImmunoassay534ErbaLisa COVID-19 IgM ELISA327Erba MannheimUnited Kingdomwww.erbamannheim.comNoCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2021-05-10 13:18:20438Immuno-AntibodyYesELISAQualitativeSandwich, Double549En Carta SARS-CoV-2347Pardee labCanadawww.pardeelab.org/NoIn developmentNoNoLab-basedAntibody2021-05-10 13:04:00465Immuno-AntibodyImmunoassay85Ella / Simple Plex COVID-19 16×4 Standard Panel51Bio-TechneUnited Kingdomwww.bio-techne.com/NoCommercialisedNoNoAutomatedManualAntibody2021-05-10 13:04:0059Immuno-AntibodyImmunoassayOtherStandard panel882Elecsys Anti-SARS-CoV-2221ROCHE DiagnosticsSwitzerlanddiagnostics.roche.comYesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum2021-05-10 13:04:00696Immuno-AntibodyYesImmunoassayQualitativeChemiluminescence18Clinical Sensitivity100%CI: 65.5 - 100Clinical Specificity99.81%544Edinburgh Genetics Complete Whole Blood Collection Kit88Edinburgh Genetics LimitedUnited Kingdomeggenetics.com/NoCommercialisedNoNoLab-basedAntibodyWhole blood2021-05-10 13:04:00460Immuno-AntibodyImmunoassaySample collection device21DrivenFlow COVID-1917Alfa Scientific Designs IncUnited Stateswww.alfascientific.com/YesCommercialisedNoNoNear POC / POCAntibody2021-05-10 13:04:0021Immuno-AntibodyYesImmunoassay1633Diagnostic kit for antibody IgM/IgG of Novel Coronavirus COVID-19729LionrunChinawww.liangrunbio.com/en/Productdetail/76NoCommercialisedNoNoCassetteLab-basedAntibody2021-05-10 13:04:001313Immuno-AntibodyImmunoassayQualitative1163CRT (COVID 19 RAPID TEST)610Oncosem Onkolojik Sistemler San. ve Tic. A.S.Turkeywww.oncosem.comYesCommercialisedNoNoLateral flowNear POC / POCAntibodyPlasmaSerumWhole blood https://oncosem.com/en/crt-2/2021-05-10 13:04:00944Immuno-AntibodyYesNoImmunoassayQualitative15Fp1%Fn5.14%Accuracy97.3%Clinical Sensitivity94.85%350CoviDx231Sengenics Corporation Pte LtdUnited Stateswww.sengenics.com/NoCommercialisedNoNoAutomatedManualAntibody2021-05-10 13:04:00294Immuno-AntibodyImmunoassay1118COVIDscreen Plus ELISA Kit19Trivitron Healthcare Pvt. LtdIndiawww.trivitron.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerum https://www.lumiradx.com/assets/pdfs/covid-19-antibody-test/qri-ab-ous-ce.pdf 2021-05-10 13:04:00899Immuno-AntibodyYesELISAQualitativeMagnetic Electrochemical90Manual or automated colorimetry Clinical Sensitivity%100Clinical Specificity%99685COVID19 IgG/IgM Rapid Test Kit556Novus BiologicalsUnited Stateswww.novusbio.comNoCommercialisedNoNoNear POC / POCAntibodyWhole blood2021-05-10 13:04:00810Immuno-AntibodyYesNoImmunoassayQualitativeColloidal goldCrossreactivityEvaluatedClinical Sensitivity1U/mlIgMClinical Sensitivity0.5U/mlIgG2002COVID-19 Sero NP/RBD73Coris BioConceptBelgiumwww.corisbio.com/YesCommercialisedNoNoCassetteLateral flowNear POC / POCAntibodyPlasmaSerumAssay evaluated with Anti-SARS-CoV-Verification Panel for Serology Assays (NIBSC code: 20/B770): 100% Accuracy. Test identifies antibodies against Nucleoprotein (NP Line) and against RBD domain of the spike protein (RBD line).2021-05-10 13:04:001679Immuno-AntibodyNoImmunochromatography15LOD10AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0%No false positivity with seasonal coronaviruses HCoV-HKU1, -NL63, -OC43, and -229EFn1.47%(4 on 271 samples)PrecisionNot evaluatedAccuracy98.5%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity98.4%(combined NP and RBD)Clinical Specificity98.5%Type of antigenOther687COVID-19 Rapid Test, WONDFO SARS-CoV-2 Antibody Test (Lateral Flow Method)422WondfoChinaen.wondfo.com.cnNoCommercialisedNoNoNear POC / POCAntibody2021-05-10 13:04:00577Immuno-AntibodyYesImmunoassayType of antigennucleoprotein1016COVID-19 Rapid Antibody Test538Biopanda Reagents LTDUnited Kingdomwww.biopanda.co.uk/YesCommercialisedNoNoLateral flowNear POC / POCAntibodyWhole blood2021-05-10 13:04:00781Immuno-AntibodyYesNoImmunoassayQualitative10Clinical Sensitivity69.4%CI: 69.4 - 100Clinical Specificity98.3% IgGClinical Specificity96.7% IgM1668COVID-19 Neutralizing Antibody Test Kit655Guangdong Wesail Biotech Co., LtdChinaen.wesailbio.comYesCommercialisedNoNoCassetteNear POC / POCAntibodyPlasmaSerumWhole blood2021-05-10 13:18:201347OtherYesYesImmunoassayQualitativeColloidal gold15LOD0Calibrationnot evaluatedCrossreactivitynot evaluatedFp1.6%Fn4.6%PrecisionevaluatedAccuracy97.9%Reproducibilitynot evaluatedRobustnessevaluatedClinical Sensitivity95.4%1577COVID-19 Neutralizing Antibody FIA455Assure Tech. (Hangzhou) Co., LtdChinawww.diareagent.com/YesCommercialisedNoNoCassetteLab-basedAntibodyPlasmaSerumWhole blood2021-05-10 13:04:001256Immuno-AntibodyYesYesImmunoassayQualitativeFluorescence15LOD0CalibrationevaluatedCrossreactivityevaluatedFpNot availableFnNot availablePrecisionevaluatedAccuracy100%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity100%1910COVID-19 Neutralizing Antibody FIA871Azure Biotech IncUnited Stateswww.azure.bioYesCommercialisedNoNoCassetteManualNear POC / POCAntibodyPlasmaSerumWhole bloodNot available2021-05-10 13:04:001585Immuno-AntibodyYesImmunoassayQualitativeNeutralization Antibody (NAb)Other15Fluorescence detectionLOD0AUCalibrationEvaluatedCrossreactivityEvaluatedPrecisionEvaluatedAccuracy100%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity100%Clinical Specificity100%Type of antigenOther1966COVID-19 NAb Rapid Test900Zhejiang Kuaye Biotechnology Co., Ltd.Chinawww.zjky-bio.comYesCommercialisedNoNoLateral flowStripNear POC / POCAntibodyPlasmaSerumVenous whole bloodWhole bloodN.A.2021-05-10 13:04:001642Immuno-AntibodyImmunochromatographyQualitativeMembrane-based15LOD10AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0%(0 out of 100)Fn6.25% (5 out of 75)PrecisionEvaluatedAccuracy97.22%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.75%Clinical Specificity100%Type of antigenOther150COVID-19 lgG, EIA-614689DRG International, IncUnited Stateswww.drg-international.com/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerum2021-05-10 13:04:00114Immuno-AntibodyNoYesImmunoassayQuantitativeFluorescence120LOD5U/mlClinical Sensitivity100% IgGClinical Sensitivity97.7% IgMClinical Specificity100% IgG754COVID-19 LAB TEST TO DETECT ANTIBODIES6AbbottUnited Stateswww.abbott.com/NoCommercialisedNoNoLab-basedAntibody2021-05-10 13:04:00609Immuno-AntibodyImmunoassay 153COVID-19 IgM ELISA Assay87Eagle Biosciences IncUnited Stateseaglebio.com/NoCommercialisedNoNoAutomatedManualAntibody2021-05-10 13:04:00110Immuno-AntibodyELISA691COVID-19 IgG/IgM Rapid Test Device423Shenzhen Landwind MedicalChinawww.landwindmedical.comNoCommercialisedNoNoNear POC / POCAntibody No info on the webiste2021-05-10 13:04:00579Immuno-AntibodyYesImmunoassayNot found1036Covid-19 IgG/IgM RAPID TEST566Assut EuropeItalywww.assuteurope.com/NoCommercialisedNoNoNear POC / POCAntibody2021-05-10 13:04:00829Immuno-AntibodyYesImmunoassay628Covid-19 IgG/IgM Antibody Test373Verify Diagnostics IncCanadaverifydiagnostics.com/NoCommercialisedNoNoNear POC / POCAntibody2021-05-10 13:04:00516Immuno-AntibodyYesImmunoassayType of antigenSARS-CoV-2 Nucleocapsid Protein154COVID-19 IgG ELISA Assay87Eagle Biosciences IncUnited Stateseaglebio.com/NoCommercialisedNoNoAutomatedManualAntibody2021-05-10 13:04:00111Immuno-AntibodyELISA32COVID-19 Hybrid Capture Fluorescence Immunoassay Test307Anbio (Xiamen) Biotechnology Co., LtdChinawww.anbio.com/NoCommercialisedNoNoNear POC / POCAntibodyWhole blood2021-05-10 13:04:00406Immuno-AntibodyNoImmunoassayQualitativeColorimetry15Automated lab-based, near-POC NAT or POC NAT card Colloidal Gold 738COVID-19 ELISA IgG Antibody Test450Mount Sinai LabsUnited Stateswww.msmc.com/clinical-services-2/laboratory/NoCommercialisedNoNoAutomatedManualAntibodySerum2021-05-10 13:04:00614Immuno-AntibodyYesELISAQualitativeFluorescence1029COVID-19 Coronavirus Rapid Test Kit613Newbury Pharmaceuticals S.ASwedenwww.newburypharma.ch/YesCommercialisedNoNoCassetteNear POC / POCAntibodyWhole bloodhttps://www.newburypharma.ch/pages/covid-19-instant-antibody-test-kit-15-min2021-05-10 13:04:00947Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry164COVID-19 Antibody Test93FemtoDxUnited Statesfemtodx.com/NoIn developmentNoNoNear POC / POCAntibody2021-05-10 13:04:00119Immuno-AntibodyImmunoassay1940COVID-19 Antibody Rapid Test Kit (QDs)886Chongqing iSIA BIO-Technology Co., LtdChinawww.isiabio.com.cnYesCommercialisedNoNoCassetteChipNear POC / POCAntibodyPlasmaSerumWhole blooduse instrument for test, quantum dots poct2021-05-10 13:04:001616Immuno-AntibodyImmunoassayImmunofluorescence15(Quantum Dots Immunofluorescence)LOD0.8AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0%Fn0%PrecisionEvaluatedAccuracy99%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity99%Clinical Specificity99%Type of antigenOther1939COVID-19 Antibody Rapid Test Kit886Chongqing iSIA BIO-Technology Co., LtdChinawww.isiabio.com.cnYesCommercialisedNoNoCassetteLateral flowNear POC / POCAntibodyPlasmaSerumWhole bloodgood feedback from market2021-05-10 13:04:001615Immuno-Antibody15LOD0.8AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0%Fn0%PrecisionEvaluatedAccuracy98%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98%Clinical Specificity97%Type of antigenOther225COVID Serology Kit: Multiplexed Immunoassay141InDevR IncUnited Stateswww.indevr.com/NoIn developmentNoNoNear POC / POCAntibody Microarray; Throughput 1,000 microarrays in 8 hours 2021-05-10 13:04:00181Immuno-AntibodyYesImmunoassay583COVID 19 IgG IgM Rapid Test366Medsource Ozone BiomedicalsIndiawww.ozonebio.com/NoCommercialisedNoNoNear POC / POCAntibody2021-05-10 13:04:00493Immuno-AntibodyYesImmunoassay735Coronavirus Disease 2019 Antibody (IgM/IgG) Combined Test Kit449MedicalSystem Biotechnology Co., LtdChinaen.nbmedicalsystem.com/en/NoCommercialisedNoNoLab-basedAntibody2021-05-10 13:04:00611Immuno-AntibodyImmunoassay667Coronavirus disease (COVID-19) Total Antibody Rapid Test (Colloidal Gold)407Chinawww.odbio.com/lxwmNoCommercialisedNoNoLab-basedAntibody No info on the webiste2021-05-10 13:04:00561Immuno-AntibodyImmunoassayQualitative521Coronavirus disease (COVID-19) Antibody Test (Up-converting Phosphor Technology)328Beijing Hotgen Biotech Co., LtdChinawww.hotgen.com.cn/YesCommercialisedNoNoNear POC / POCAntibody2021-05-10 13:04:00451Immuno-AntibodyYesYesImmunoassayQualitative15Rapid diagnostic test card 519Coronavirus disease (COVID-19) Antibody Test (Colloidal Gold)328Beijing Hotgen Biotech Co., LtdChinawww.hotgen.com.cn/YesCommercialisedNoNoNear POC / POCAntibodyPlasmaSerum2021-05-10 13:04:00437Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry15341CoronaCide222CoronaCideUnited Stateswww.coronacide.com/NoCommercialisedNoNoNear POC / POCAntibody2021-05-10 13:04:00284Immuno-AntibodyYesImmunoassayRapid diagnostic test 1923Coretests COVID-19 Neutralizing Ab Test420Core Technology Co., LtdChinawww.coretests.comYesCommercialisedNoNoCassetteNear POC / POCAntibodyPlasmaSerumWhole bloodCOVID-19 Neutralizing Ab Test is used for qualitative detection of the Neutralizing antibodies in patients who have recovered from Novel Coronavirus Pneumonia or those who have been vaccinated. The neutralizing antibody protects the host from infection by neutralizing the activity of the virus. It is a specific antibody that can block the virus from invading cells. The neutralizing antibody is produced by the immune response after a person is vaccinated or infected with a virus. Its titer will directly determine the body's ability to neutralize the virus, that is, the body's ability to avoid virus infection. Coretests® COVID-19 Neutralizing Ab Test can detect neutralizing antibodies faster, and the test only takes 10-15 minutes.2021-05-10 13:18:201599Immuno-AntibodyNoImmunoassayQualitativeSandwichOther15LODAU25CalibrationEvaluatedCrossreactivityEvaluatedFp%0.7%Fn%0.8%PrecisionEvaluatedAccuracy%99.3ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity%99.2Clinical Specificity%99.3Type of antigenOther767Confidence COVID-19 Rapid Test462Applied Biomedical, LLCUnited Stateswww.appliedbiomedical.comNoCommercialisedNoNoFingertipNear POC / POCAntibodyWhole blood2021-05-10 13:04:00637Immuno-AntibodyYesNoImmunoassayQualitative20354Cleartest Corona, Covid-19242servoprax GmbHGermanywww.servoprax.de/YesCommercialisedNoNoNear POC / POCAntibody2021-05-10 13:04:00305Immuno-AntibodyYesImmunoassay632careUS COVID-19 IgM/IgG300Wells Bio, IncSouth Koreawww.wellsbio.net/eng/NoIn developmentNoNoNear POC / POCAntibody2021-05-10 13:04:00520Immuno-AntibodyYesImmunoassay111Camtech COVID-19 Rapid Test Kit415CamtechSingaporecovid19-test.com/YesCommercialisedNoNoCassetteNear POC / POCAntibodyWhole blood2021-05-10 13:04:00570Immuno-AntibodyYesNoImmunoassayQualitativeNot found10CrossreactivityReportedClinical Sensitivity87.5%Clinical Specificity100%779BIOSYNEX COVID-19 BSS651BIOSYNEX S.A.Francewww.biosynex.comYesCommercialisedNoNoLab-basedAntibodyWhole blood2021-05-10 13:18:20821Immuno-AntibodyYesNoImmunoassayQualitative10Not found cassette Not found 290BioPoint SARS-CoV-2 dIgA/total antibody rapid test183Nanjing BioPoint DiagnosticsChinaen.njbiopoint.com/index.htmlNoIn developmentNoNoNear POC / POCAntibody2021-05-10 13:04:00240Immuno-AntibodyYesImmunoassay602BIOCREDIT COVID-19 IgG220RapiGEN IncSouth Korearapigen-inc.comNoCommercialisedNoNoNear POC / POCAntibody2021-05-10 13:04:00489Immuno-AntibodyYesImmunoassayType of antigenSARS-CoV-2 recombinant antigens conjugated to colloidal gold1116Biocard Covid-19 Rapid Test19Trivitron Healthcare Pvt. LtdIndiawww.trivitron.com/YesCommercialisedNoNoManualAntibody The GENEDIA W COVID-19 Ag is an in vitro diagnostic single-use test and qualitative immunoassay to detect SARS-CoV-2 antigen in nasopharyngeal swab and sputum specimen from human. This assay is designed for professional personnel in laboratory and at point-of-care as an aid in screening patients suspected of being infected and asymptomatic patients. 2021-05-10 13:04:0023Immuno-AntibodyYesNoImmunoassayQualitativeColorimetry151498Bio-Shield 2019-nCov Total Ig688Prognosis BiotechGreecewww.prognosis-biotech.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerumWhole blood2021-05-10 13:04:001248Immuno-AntibodyYesImmunoassayQualitativeSandwich, Double120LOD1AUCalibrationevaluatedCrossreactivityevaluatedFp0%Fn1%PrecisionevaluatedAccuracy99.86%ReproducibilityevaluatedRobustnessevaluatedClinical Sensitivity100%50Baiya Rapid COVID-19 IgM/IgG test kit32Baiya Phytopharm, Co., LtdThailandbaiyaphytopharm.wixsite.com/baiyaNoIn developmentNoNoNear POC / POCAntibody2021-05-10 13:04:0037Immuno-AntibodyYesImmunoassay775AxiumHealth COVID-19 IgG/IgM Antibody Test465Axium Bioresearch IncUnited Stateswww.axiumbioresearch.com/NoCommercialisedNoNoLab-basedAntibody2021-05-10 13:04:00644Immuno-AntibodyImmunoassayType of antigenSARS-COV-2 nucleoprotein771Atlas COVID-19 Total Antibody Elisa Kit314Atlas MedicalUnited Kingdomatlas-medical.com/YesCommercialisedNoNoN.A.AutomatedManualAntibodySerum2021-05-10 13:04:00625Immuno-AntibodyYesELISAQualitativeSandwich, Double70Manual or automated Sandwich, Double 665Anti-SARS-CoV-2 Rapid Test513Autobio Diagnostics Co., LtdChinawww.autobio.com.cn/en/NoCommercialisedNoNoCassetteNear POC / POCAntibody2021-05-10 13:04:00800Immuno-AntibodyYesImmunoassayQualitativeNot foundType of antigenSARS-CoV-2 nucleocapsid1864Anti-SARS-CoV-2 Neutralizing Antibody ELISA Kit184Nanjing Vazyme Medical Technology Co., LtdChinawww.vazymebiotech.com/YesCommercialisedNoNoMicroplateManualAntibodyPlasmaSerumhttp://www.vazymebiotech.com/COVID.html2021-05-10 13:04:001541Immuno-AntibodyYesELISAQualitativeEnzyme-linkedOther120LOD92.5AUCalibrationNot evaluatedCrossreactivityEvaluatedFp0%Fn1%PrecisionEvaluatedAccuracy99.27%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity98.5%Clinical Specificity99.3%Type of antigenOther2046Anti-SARS-CoV-2 Neutralizing Antibody ELISA Kit943Beijing Bohui Innovative Biotechnology Co., Ltd.Chinahttp://www.bohui-tech.com/YesCommercialisedNoNoAutomatedManualAntibodyPlasmaSerumWhole bloodWe have CE marking, registered in Spanien. The products was registered in Spanish MOH with number RPS/294/2021.2021-05-10 13:04:001724Immuno-AntibodyImmunochromatographyNeutralization Antibody (NAb)120LOD20AUCalibrationEvaluatedCrossreactivityEvaluatedFp1.47%Serum: 3/204;Fp1.98%Whole blood:4/202Fp1.47%Plasma: 3/203Fn0.96%Plasma: 4/414Fn1.44%Whole blood:6/415Fn0.72%Serum: 3/413;PrecisionEvaluatedAccuracy97%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity97.06%Whole blood: (95% CI: 93.73%~98.65%)Clinical Sensitivity98.04%Plasma:(95% CI: 95.07%~99.23%) Clinical Sensitivity98.53%Serum: (95% CI: 95.77%~99.50%) Clinical Specificity99.27%Plasma: (95% CI: 97.89%~99.75%). Clinical Specificity99.03%Whole blood: (95% CI: 97.54%~99.62%).Clinical Specificity99.27%Serum: (95% CI: 97.89%~99.75%) Type of antigenOther340Anti-SARS-CoV-2 enzyme immunoassay for the detection of antibodies to SARS-CoV-2 (COVID-19)228RPC Diagnostic SystemsRussiawww.npods.ru/NoIn developmentNoNoAutomatedManualAntibody2021-05-10 13:04:00291Immuno-AntibodyImmunoassay578ANTI COVID-19 IGG/IGM RAPID TEST348Labtest DiagnosticaBrazillabtest.com.br/en/NoCommercialisedNoNoCassetteNear POC / POCAntibodyPlasmaSerum2021-05-10 13:04:00466Immuno-AntibodyYesNoImmunoassayQualitativeFpEvaluatedFnEvaluatedClinical Sensitivity85% IgMClinical Sensitivity100% IgGClinical Specificity96% IgMClinical Specificity98% IgG557ACE2 antibody [N1N2], N-term (GTX101395)353GeneTex International CorporationUnited Stateswww.genetex.com/NoCommercialisedNoNoAutomatedManualAntibody2021-05-10 13:04:00472Immuno-AntibodyImmunoassay1985Absoludy COVID-19 NAb Rapid909Absology Co., Ltd.South Koreawww.absology.co.krNoIn developmentNoNoCardLateral flowManualAntibodySerumAbsoludy COVID-19 NAb Rapid is intended for detection of neutralizing antibody to SARS-CoV-2 virus (COVID-19) in human serum.2021-05-10 13:04:001661Immuno-AntibodyNoImmunochromatographyQualitativeNeutralization Antibody (NAb)15LOD20AUCalibrationEvaluatedCrossreactivityEvaluatedFpEvaluation ongoingFnEvaluation ongoingPrecisionEvaluatedAccuracy90%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity90%Clinical Specificity95%Type of antigenNucleoprotein1983Absoludy COVID-19 NAb909Absology Co., Ltd.South Koreawww.absology.co.krNoIn developmentNoNoCartridgeLateral flowNear POC / POCSemi-automatedAntibodySerumAbsoludy COVID-19 NAb is intended for detection of nuetralizing antobody to SARS-CoV-2 virus (COVID-19) in human serum specimens. This product is for professional use.2021-05-10 13:04:001659Immuno-AntibodyYesImmunoassaySemiquantitativeNeutralization Antibody (NAb)6LOD20CalibrationEvaluatedCrossreactivityEvaluatedFpEvaluation ongoingFnEvaluation ongoingPrecisionEvaluatedAccuracy95%ReproducibilityEvaluatedRobustnessNot evaluatedClinical Sensitivity96%Clinical Specificity100%Type of antigenOther505abia SARS-CoV-2 Ab320AB Dianostic Systems GmbHGermanywww.ab-ds.de/NoIn developmentNoNoAutomatedManualAntibody2021-05-10 13:04:00424Immuno-AntibodyImmunoassay277@sight COVID-19 IgG/IgM Rapid Test Kit172Mediclone Biotech Pvt LtdIndiamediclonebiotech.com/NoNoNoNear POC / POCAntibody2021-05-10 13:04:00228Immuno-AntibodyYesImmunoassay61239508R-Sengenics Respiratory Virus Protein Microarray231Sengenics Corporation Pte LtdUnited Stateswww.sengenics.com/NoCommercialisedNoNoAutomatedManualAntibody2021-05-10 13:04:00506Immuno-AntibodyImmunoassayMicroarray61139507-Recombinant Influenza A and B Ha Protein231Sengenics Corporation Pte LtdUnited Stateswww.sengenics.com/NoCommercialisedNoNoAutomatedManualAntibody2021-05-10 13:04:00505Immuno-AntibodyImmunoassay61039506-Recombinant MERS-CoV Nucleocapsid Protein231Sengenics Corporation Pte LtdUnited Stateswww.sengenics.com/NoCommercialisedNoNoAutomatedManualAntibody2021-05-10 13:04:00502Immuno-AntibodyImmunoassay60939505-Recombinant SARS-CoV (2004) Nucleocapsid Protein231Sengenics Corporation Pte LtdUnited Stateswww.sengenics.com/NoCommercialisedNoNoAutomatedManualAntibody2021-05-10 13:04:00501Immuno-AntibodyImmunoassay60839504-Recombinant SARS-CoV-2 Envelope Protein231Sengenics Corporation Pte LtdUnited Stateswww.sengenics.com/NoCommercialisedNoNoAutomatedManualAntibody2021-05-10 13:04:00500Immuno-AntibodyImmunoassay60739503-Recombinant SARS-CoV-2 Spike (R682S) Protein231Sengenics Corporation Pte LtdUnited Stateswww.sengenics.com/NoCommercialisedNoNoAutomatedManualAntibody2021-05-10 13:04:00499Immuno-AntibodyImmunoassay60639502-Recombinant SARS-CoV-2 Spike Protein231Sengenics Corporation Pte LtdUnited Stateswww.sengenics.com/NoCommercialisedNoNoAutomatedManualAntibody2021-05-10 13:04:00495Immuno-AntibodyImmunoassay60539501-Recombinant SARS-CoV-2 Nucleocapsid Protein231Sengenics Corporation Pte LtdUnited Stateswww.sengenics.com/NoCommercialisedNoNoAutomatedManualAntibody2021-05-10 13:04:00492Immuno-AntibodyImmunoassay2142019-nCov Rapid Test Kit130Hangzhou Matridx Biotechnology Co., LtdChinawww.matridx.com/matridx.htmlNoCommercialisedNoNoManualAntibody2021-05-10 13:04:00170Immuno-AntibodyImmunoassay18122019-nCoV Neutralizing Antibody Test Kit (Fluorescent immunochromatography)779Guangdong Hecin Scientific, Inc.Chinawww.hecin-scientific.cn/YesCommercialisedNoNoLab-basedAntibody2021-05-10 13:04:001491Immuno-AntibodyImmunochromatographyQualitativeNeutralization Antibody (NAb)15fluorescence detectionLOD1AUCalibrationEvaluatedCrossreactivityEvaluatedFp5Fn3PrecisionEvaluatedAccuracy97.32%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity96.74%Clinical Specificity97.58%18112019-nCoV Neutralizing Antibody Test Kit (colloidal gold method)779Guangdong Hecin Scientific, Inc.Chinawww.hecin-scientific.cn/YesCommercialisedNoNoCassetteLab-basedAntibody2021-05-10 13:04:001490Immuno-AntibodyYesImmunoassayQualitativeNeutralization Antibody (NAb)15LOD1AUCalibrationEvaluatedCrossreactivityEvaluatedFp16AU16Fn8AU8PrecisionEvaluatedAccuracy91.97%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity91.3%Clinical Specificity92.27%Type of antigenother18792019-nCoV Neutralizing Antibody Test Kit (Colloid Gold Immunoassay)860Ustar Biotechnologies (Hangzhou) LtdChinaen.bioustar.comYesCommercialisedNoNoCassetteNear POC / POCAntibodyThe 2019-nCoV Neutralizing Antibody Test Kit (Colloid Gold Immunoassay) is intended for in-vitro diagnosis of novel coronavirus neutralizing antibodies in human serum, plasma, venous whole blood or peripheral whole blood.2021-05-10 13:04:0017062019-nCoV NAb Control (CLIA)379SHENZHEN YHLO BIOTECH CO., LtdChinawww.szyhlo.comYesCommercialisedNoNoAutomatedManualAntibodyOther2021-05-10 13:04:001386Immuno-AntibodyYesOtherChemiluminescenceCalibrant / control sample30LOD0AUCalibrationnot evaluatedCrossreactivitynot evaluatedPrecisionevaluatedReproducibilityevaluatedRobustnessevaluated6742019-nCoV IgG/IgM Rapid Test Dipstick126Hangzhou AllTest Biotech Co., LtdChinawww.alltests.com.cn/NoCommercialisedNoNoDipstickNear POC / POCAntibody2021-05-10 13:04:00567Immuno-AntibodyYesImmunoassay16282019-nCoV IgG/IgM Rapid Test724TD diagnosticsCanadawww.td-diagnostics.comNoCommercialisedNoNoCassetteNear POC / POCAntibody2021-05-10 13:04:001308Immuno-AntibodyYesImmunoassay10112019-NCOV IGG/IGM555Intermedical SRLItalywww.intermedical.it/prodotti/test-rapidi/NoCommercialisedNoNoNear POC / POCAntibody2021-05-10 13:04:00808Immuno-AntibodyYesImmunoassay10002019-nCoV Ab Test (Colloidal Gold)533Hangzhou Singclean Medical Products Co., LtdChinawww.singclean.net/YesCommercialisedNoNoCassetteNear POC / POCAntibodyWhole blood2021-05-10 13:18:20907Immuno-AntibodyYesNoImmunoassayQualitativeColloidal gold15CrossreactivityReportedClinical Sensitivity87.3%Clinical Specificity100%1952019 Novel Coronavirus (2019-nCoV) IgM Antibody Detection Kit (ELISA Method)116Guangzhou Darui Biotechnology Co.,LtdChinawww.daruibiotech.com/NoCommercialisedNoNoAutomatedManualAntibody2021-05-10 13:04:00151Immuno-AntibodyELISA1962019 Novel Coronavirus (2019-nCoV) IgG Antibody Detection Kit (ELISA Method)116Guangzhou Darui Biotechnology Co.,LtdChinawww.daruibiotech.com/NoCommercialisedNoNoAutomatedManualAntibody2021-05-10 13:04:00152Immuno-AntibodyELISA10202019 NCOV IGG/IGM TEST559Microtrace Diagnostici SRLItalywww.microtrace.it/laboratori/NoCommercialisedNoNoLab-basedAntibody2021-05-10 13:04:00815Immuno-AntibodyImmunoassay1951SmartAmp SARS-CoV-2 RNA detection test kit892LLC EMG- Evotech Mirai GenomicsRussiaevotech-mg.com/en/YesCommercialisedNoNoManualOtherSemi-automatedNasopharyngeal swabOropharyngeal swabSputumSmartAmp® SARS-CoV-2 Detection Kit combines reverse transcription and SmartAmp® DNA amplification in a single step, together with Eprobe® mediated real-time monitoring of amplification. SmartAmp is an isothermal DNA amplification technology which was developed by the group of Yoshihide Hayashizaki at the RIKEN institute, Japan. The test detects a highly conserved region within the Nsp15 gene, coding for endonuclease NSP15. An in vitro synthesized fragment of human RNA (RPP30 gene) is used as internal control of the extraction, reverse transcription and amplification reaction.2021-05-10 13:04:001627Nucleic acid-OtherYesLAMPQualitativeOther40LOD10000cpuPositive controlin vitro synthesized fragment of SARS-CoV-2 coronavirus RNANegative controlPCR grade waterClinical Sensitivity%100Clinical Specificity%98.71999See Now Coronavirus nCoV antigen test918CAMP MEDICA DISTRIBUTIONRomaniawww.campmedica.roYesCommercialisedNoNoCardCassetteLateral flowLab-basedManualNasal swabNasopharyngeal swabOropharyngeal swabThe “See Now” Coronavirus (SARS-CoV-2) Antigen test is an immunochromatographic lateral flow device that employs the principle of double antibody sandwich method. The “See Now” Coronavirus nCoV Antigen test is used for the qualitative detection of SARS-CoV-2 antigens in nasal swabs, nasopharyngeal swabs or oropharyngeal swabs.2021-05-10 13:04:001676Immuno-AntigenImmunochromatographyQualitativeSandwich, Double15LOD1300TCID50/ml(1.3 x102 TCID50/mL)Positive controlyesNegative controlyesAnalytical Sensitivity97%Analitical Specificity99%Clinical Sensitivity97%Clinical Specificity99%1869SARS-CoV-2 Nucleic Acid Detection Kit(Multiplex PCR Fluorescent Probe Method)859Foregene Co., LtdChinawww.foregene.comYesCommercialisedNoNoStripLab-basedManualNasopharyngeal swabOropharyngeal swabQuick and easy; Avoid nucleic acid loss; Low detection limit and high sensitivity; Low equipment requirement and highly flexible use2021-05-10 13:04:001546Nucleic acid-PCRRT-PCRQualitativeFluorescenceOther55Target: S gene, fluorescence detectionLOD500copies/mlAnalytical Sensitivity96.72%Analitical Specificity97.92%Clinical Sensitivity96%Clinical Specificity97%1979SARS-CoV-2 Nucleic acid detection kit based on Cartridge Real-Time PCR platform907Tellgen CorporationChinaen.tellgen.com/YesCommercialisedNoNoCassetteAutomatedNasopharyngeal swabCharacteristic: Sample in, Result out, Random testing, Close system - SARS CoV 2 PCR Cartridge - The only manual operation step is adding sample - Inserting the Cartridge and start automated PCR processing - Real time PCR 4 channels, random testing TAT is 1.5 hours2021-05-10 13:04:001655Nucleic acid-PCRYesRT-PCRQuantitativeMultipleOther75LOD100cprPositive control97.87%Negative control95.41%Analytical Sensitivity95%Analitical Specificity100%Clinical Sensitivity95.96%Clinical Specificity98.08%1916SARS-CoV-2 Fluorescent PCR Kit168Maccura Biotechnology Co., LtdChinawww.maccura.com/enYesCommercialisedNoNoAutomatedOropharyngeal swabFDA EUA，China NMPA2021-05-10 13:18:201593Nucleic acid-PCRRT-PCRQualitativeFluorescence detection1861SARS-CoV-2 ELITe MGB® Kit852ELITechGroupFrancewww.elitechgroup.comYesCommercialisedNoNoCartridgeCassetteMicroplateAutomatedFully automated (robot)Lab-basedNasal swabNasopharyngeal swabOropharyngeal swabSalivaEndogenous Internal Control: RNase-P Available both Qualitative and Quantitative assay in association with SARS-CoV-2 ELITe Standard. Two available formats: 96 and 240 reactions. Validated in association to the S2R platform ELITe InGenius® and CFX-96 and ABI 7500 Fast Dx2021-05-10 13:04:001612Rapid COVID-19 AntigenTest554Healgen ScientificUnited Stateswww.healgen.comNoCommercialisedNoNo2021-05-10 17:22:041857Nucleic Acid Extraction or Purification Kit319Beijing Lepu Medical Technology Co., LtdChinaen.lepumedical.com/YesCommercialisedNoNoOtherAutomatedBronchoalveolar lavage fluidMid-turbinates swabNasal swabNasopharyngeal swabPlasmaSerumThroat swabTissue homogenatesWhole bloodNO2021-05-10 13:18:201925Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (RT-PCR)472Genrui Biotech IncChinawww.genrui-bio.com/YesCommercialisedNoNoManualOropharyngeal swabSputumThe N, S and ORF1ab genes of Novel Coronavirus (2019-nCoV) are selected as target region.2021-05-10 13:18:201601Nucleic acid-PCRRT-PCRLOD200cpuClinical Sensitivity98.84%Clinical Specificity100%2019Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (PCR-Fluorescence Probing)927Shanghai BioGerm Medical Technology Co., Ltd.Chinahttp://m.bio-germ.com/YesCommercialisedNoNoCassetteStripLab-basedManualNasopharyngeal swabOropharyngeal swabSputumAres(2021)29312282021-05-10 13:04:001697Nucleic acid-PCRRT-PCRFluorescence80CV Value could reach 3%; 96 samples per runLOD500cpmPositive control612AUNegative control612AUAnalytical Sensitivity0AUClinical Sensitivity99.24%Clinical Specificity99.14%2014MutaPLEX® Coronavirus Real-Time-RT-PCR-Kit845Immundiagnostik AGGermanywww.immundiagnostik.comYesCommercialisedNoNoOtherManualMid-turbinates swabNasal swabNasopharyngeal swabOropharyngeal swabSalivaSputumMutaPlex Coronavirus Real-Time-RT-PCR-Kit was developed for the simultaneous in vitro detection of RNA of novel coronavirus and subgenus Sarbecovirus extracted from biological specimens. The simultaneous detection of 3 target sequences(RdRP-Gen, S-Gen and E-Gen) also increases the diagnostic safety in case of mutations of the target sequence.2021-05-10 13:04:001692Nucleic acid-PCRYesRT-PCRQuantitativeMultipleOther65LODOne copyPositive controlyes with 10,000 copies per PCRNegative controlyes, including internal controlAnalytical Sensitivity100%Analitical Specificity100%Clinical Sensitivity100%Clinical Specificity100%1898Fully Automated Nucleic Acid Extractor (magnetic beads adsorption)866Yantai Addcare Bio-TechChinawww.addcare.cn/en/NoCommercialisedNoNoOther2021-05-10 13:04:001574OtherExtraction kit1954Dr. PCR™ Di20K COVID-19 Detection kit894OPTOLANE Technologies, Inc.South Koreawww.optolane.com/YesCommercialisedNoNoCartridgeManualNasopharyngeal swabOropharyngeal swabDigital Real-time PCR2021-05-10 13:04:001630Nucleic acid-PCRYesRT-PCRQualitative60LOD2.5cpm(RdRp and E gene)Clinical Sensitivity100%Clinical Specificity100%1001993Dr Vida pocket for COVID-19914STAB VIDAPolandwww.stabvida.com/YesCommercialisedNoNoOtherAutomatedNear POC / POCNasal swabNasopharyngeal swabDoctor Vida pocket is very small portable, handheld device for isothermal nucleic acid amplification of viral genetic biomarkers. It is operated from any smartphone in a clinical or research setting, but also at home, at the office, etc. There is almost no sample preparation, other than collecting the swab sample into the resuspension medium and pipetting a few ul of the sample into a single-use reaction tube, a 5-10 minute preparation time. No RNA extraction and purification is needed. Doctor Vida pocket is a multi use pocket analyser that runs single samples, with low risk of contamination. After running for a period of 20- 50 min, depending on the viral load, the isothermal nucleic acid amplification will detect viral RNA in the test tube if present, by targeting its N gene and amplifying it exponentially. This will be reported as a positive result. If no viral RNA is detected, the device will report a negative test result. The higher the specimen’s viral load, the sooner the equivalent CT will be triggered. By sending the results data to the smartphone by bluetooth, a graph will show from no amplification (negative result) to exponential amplification occuring at different CT times (positive results, with an indication of the amount of viral in sample, based on the CT time).2021-05-10 13:04:001669Nucleic acid-OtherYesLAMPQualitativeOther50NIID_2019_nCOV_N, isothermal nucleic acid amplificationLOD40cprPositive controlSARS-CoV-2 inactivated particlesNegative controlHuman CellsAnalytical Sensitivity95%Analitical Specificity98%Clinical Sensitivity95%Clinical Specificity98%1866DirectDetect SARS-CoV-2 Detection Kit (PCR-Fluorescence Probe)856Coyote Bioscience Co., Ltd.Chinawww.coyotebio.com/gykydYesCommercialisedNoNoMicroplateManualNasopharyngeal swabOropharyngeal swabThe DirectDetect SARS-CoV-2 Detection Kit is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in nasopharyngeal/oropharyngeal swabs2021-05-10 13:04:001543Nucleic acid-PCRYesRT-PCRQuantitative100LOD400cpmPositive controlnon-infectious armored RNA with the ORF1ab and N gene sequence of SARA-CoV-2 in sample storNegative controlnon-infectious armored RNA with RNP sequence in sample storage solution1955Direct Dr. PCR™ SARS-CoV-2 Detection kit894OPTOLANE Technologies, Inc.South Koreawww.optolane.com/YesCommercialisedNoNoCartridgeManualNasopharyngeal swabOropharyngeal swabDigital Real-Time PCR2021-05-10 13:04:001631Nucleic acid-PCRRT-PCRQualitative60LOD2.5cpu(for RdRp gene)Clinical Sensitivity100%Clinical Specificity100%28COVID-19/Influenza A virus/Influenza B virus test kit (Rare Earth Nano Fluorescence Immunochromatography)412VazymeChinawww.vazymebiotech.com/YesCommercialisedNoNo2021-05-10 13:04:001942COVID-19 Antigen Test Kit884Surge Medical Inc.Netherlandswww.surge-on.nl/YesCommercialisedNoNo2021-05-10 13:04:001618Immuno-AntigenImmunoassay15LOD100000AUCalibrationEvaluatedCrossreactivityEvaluatedFp99%Fn93.33%PrecisionEvaluatedAccuracy97.69%ReproducibilityEvaluatedRobustnessEvaluatedClinical Sensitivity93.33%Clinical Specificity99%Type of antigenNucleoprotein