| CE Marking | Manufacturer | Commercial Name | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: LumiQuick Diagnostics Inc | Commercial: QuickProfile COVID-19 Antigen Test | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: LumiQuick Diagnostics Inc | Commercial: QuickProfile 2019-nCoV IgG/IgM Combo Test Card | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Denka Seiken Co. Ltd | Commercial: QuickNavi-COVID19 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Zymo Research Corp | Commercial: Quick SARS-CoV-2 Multiplex Kit | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Aura Biotechnologies Ltd | Commercial: Quick COVID-19 Realtime Multiplex PCR | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Aura Biotechnologies Ltd | Commercial: Quick COVID-19 Colorimetric LAMP PCR | Method: LAMP | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Clonit | Commercial: quanty-CONV-19 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: QuantuMDx | Commercial: QuantuMDx NAT for SARS-CoV-2 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: DiaCarta | Commercial: QuantiVirus SARS-CoV-2 test kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: DiaCarta | Commercial: QuantiVirus SARS-CoV-2 Multiplex Test Kit | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Attomarker Ltd | Commercial: Quantitative Immuno-kinetic assay for Covid-19 IgG+IgM+IgA for a multiantigen panel with CRP | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Huwel Lifesciences Pvt. Ltd | Commercial: Quantiplus CORONA Virus (2019nCoV) detection kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: BillionToOne, Inc | Commercial: qSanger-COVID-19 Assay | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: QuantuMDx | Commercial: QPOC Point of Care NAT for SARS-CoV-2 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: CellSafe | Commercial: Qplex COVID-19 RT-qLAMP Assay | Method: LAMP | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: PCR BioSystems | Commercial: qPCRbio Probe 1-step-go Kit | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Vitassay | Commercial: qPCR SARS-CoV-2 (test description in spanish and english) | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Canvax Biotech | Commercial: qMAXSen Coronavirus (SARS-CoV-2) RT-qPCR Detection Kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: QIAGEN GmbH | Commercial: QIAstat-Dx Respiratory Panel 2019-nCoV | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Genomica Sau | Commercial: qCOVID-19 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: JN Medsys | Commercial: ProTect Covid-19 RT-qPCR kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: ACON Laboratories, Inc | Commercial: Promotor SARS-CoV-2 RT-PCR Test Kit | Method: RT-PCR | Target: Nucleic acid | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Acon Biotech (Hangzhou) Co., Ltd | Commercial: Promotor SARS-CoV-2 RT-PCR Test Kit | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: PRIMA Lab S.A. | Commercial: PRIMA COVID-19 IgG/IgM Rapid Test (For Professional Use) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AZZ | Commercial: PRESTO 2019-nCoV Direct qPCR Kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Kogene Biotech | Commercial: PowerChek 2019-nCoV Real-time PCR Kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: GeneReach Biotechnology Corporation | Commercial: POCKIT Central SARS-CoV-2 (orf 1ab) Premix Reagent | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Manual | Go to details |
| CE Marking: No | Manufacturer: PlexBio Co., Ltd | Commercial: PlexBio CoVid19/SARS/Influenza A, B Detection kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Bio-Rad Laboratories, Inc | Commercial: Platelia SARS-CoV-2 Total Ab Assay | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Pinpoint Science Inc | Commercial: Pinpoint Covid-19 Screening Assay – Electrical detection of SARS-CoV-2 nucleocapsid protein using nanosensors and aptamer | Method: Other | Target: Other | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Procomcure Biotech GmbH | Commercial: PhoenixDx SARS-Cov-2 IVD | Method: RT-PCR | Target: Nucleic acid | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Caspr Biotech | Commercial: Phantom 1.0 Dx (near POC) | Method: CRISPR | Target: Nucleic acid | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Nirmidas Biotech, Inc | Commercial: pGOLD COVID-19 IgG/IgM/IgA Microarray Test | Method: Other | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: PerkinElmer Inc | Commercial: PerkinElmer SARS-CoV-2 Realtime RT-PCR Assay | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: PerkinElmer Inc | Commercial: PerkinElmer New Coronavirus Nucleic Acid Detection Kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Jiangsu Bioperfectus Technologies Co. Ltd | Commercial: PerfectQ COVID-19 Coronavirus Real Time PCR Kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Bioperfectus Technologies Co. Ltd | Commercial: PerfectPOC Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: PEPperPRINT GmbH | Commercial: PEPperCHIP SARS-CoV-2 Proteome Microarray (manual) | Method: Other | Target: Other | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Scope Fluidics SA | Commercial: PCR|COV | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: PCL Inc | Commercial: PCLMD nCoV one step RT-PCR Kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: PCL Inc | Commercial: PCL COVID19 IgG/IgM Rapid Gold | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: PCL Inc | Commercial: PCL COVID19 Ag Rapid FIA | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: PCL Inc | Commercial: PCL COVID19 Ag Gold | Method: | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: PaxGen Bio Co. Ltd | Commercial: PaxView COVID-19 real time RT-PCR | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Mylab Discovery Solutions Pvt. Ltd | Commercial: PathoDetect CoVID-19 Detection Kit | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Hologic | Commercial: Panther Fusion SARS-CoV-2 assay | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Pantest SA | Commercial: Pantest de Coronavirus IgM/IgG 2019-n-CoV | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Pantest SA | Commercial: Pantest Coronavirus Ag | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Aldatu Biosciences | Commercial: PANDAA qDx SARS-CoV-2 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Abbott Rapid Diagnostics | Commercial: Panbio COVID-19 Ag Test | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements