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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

Scientific literature on COVID-19 Test Methods and Devices - detail

COVID-19 Special Column: Principles Behind the Technology for Detecting SARS-CoV-2, the Cause of COVID-19

Detection Principle
S protein, N protein, E protein, ORF1ab segment for PCR; IgG, IgM, IGA for serological tests
Testing Method Category
Testing Method
39 molecular diagnostic tests: QIAstat-Dx Respiratory SARS-CoV-2 Panel (QIAGEN GmbH); NeuMoDx SARS-CoV-2 Assay (NeuMoDx Molecular, Inc.); NxTAG CoV Extended Panel Assay (Luminex Molecular Diagnostics, Inc.); ID NOW COVID-19 (Abbott Diagnostics Scarborough, Inc.); Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV (BGI Genomics Co. Ltd); AvellinoCoV2 test (Avellino Lab USA, Inc.); PerkinElmer New Coronavirus Nucleic Acid Detection Kit (PerkinElmer, Inc.); Accula SARS-Cov-2 Test (Mesa Biotech Inc.); BioFire COVID-19 Test (BioFire Defense, LLC); Xpert Xpress SARS-CoV-2 test (Cepheid); Primerdesign Ltd COVID-19 genesig Real-Time PCR assay (Primerdesign Ltd.); ePlex SARS-CoV-2 Test (GenMark Diagnostics, Inc.); Simplexa COVID-19 Direct assay (DiaSorin Molecular LLC); Abbott RealTime SARS-CoV-2 assay (Abbott Molecular); Quest SARS-CoV-2 rRT-PCR (Quest Diagnostics Infectious Disease, Inc.); Lyra SARS-CoV-2 Assay (Quidel Corporation); COVID-19 RT-PCR Test (Laboratory Corporation of America); Panther Fusion SARS-CoV-2 (Hologic, Inc.); TaqPath COVID-19 Combo Kit (Thermo Fisher Scientific, Inc.); cobas SARS-CoV-2 (Roche Molecular Systems, Inc.); New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel (Wadsworth Center, New York State Department of Public Health's); CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel (CDC) (Centers for Disease Control and Prevention's). 18 high complexity molecular-based laboratory developed tests: UDX SARS-CoV-2 Molecular assay (Ultimate Dx Laboratory); SARS-CoV-2 Assay (AIT Laboratories); COVID-19 Key (Southwest Regional PCR Laboratory LLC. dba MicroGen DX); SARS-CoV-2 PCR Test (Diatherix Eurofins Laboratory); SARS-CoV-2 Molecular Detection Assay (Mayo Clinic Laboratories, Rochester, MN); CDI Enhanced COVID-19 Test (Hackensack University Medical Center (HUMC) Molecular Pathology Laboratory; CirrusDx SARS-CoV-2 Assay (CirrusDx Laboratories); Childrens-Altona-SARS-CoV-2 Assay (Infectious Diseases Diagnostics Laboratory (IDDL), Boston Children's Hospital); SARS-CoV-2 Assay (Exact Sciences Laboratories); SARS-CoV-2 Assay (Integrity Laboratories); COVID-19 RT-PCR Test (Pathology/Laboratory Medicine Lab of Baptist Hospital Miami); Orig3n 2019 Novel Coronavirus (COVID-19) Test (Orig3n, Inc.); ThermoFisher - Applied Biosystems TaqPath COVID-19 Combo Kit (Rutgers Clinical Genomics Laboratory-Rutgers University); SDI SARS-CoV-2 Assay (Specialty Diagnostic (SDI) Laboratories); UNC Health SARS-CoV-2 real-time RT-PCR test (University of North Carolina Medical Center); Stanford SARS-CoV-2 assay (Stanford Health Care Clinical Virology Laboratory); Viracor SARS-CoV-2 Assay (Viracor Eurofins Clinical Diagnostics); MGH COVID-19 qPCR assay (Massachusetts General Hospital); SARS-CoV-2 RT-PCR test (Infectious Disease Diagnostics Laboratory- Children's Hospital of Philadelphia); SARS-CoV-2 PCR test (Yale New Haven Hospital, Clinical Virology Laboratory). 7 serological diagnostic tests: (NCT04261426 [China];36 NCT04264858 [China];37 NCT04332380 [Colombia];38 NCT04332835 [Colombia]; 39 NCT04323800 [US, Johns Hopkins];40 NCT04325672 [US, Mayo Clinic];41 NCT04333251 [US, Baylor])
Testing Method - Additional Info
Full article available at:
Reported Performance
Sample Size
from 1 to 288 (see Table 1 for molecular diagnostic tests)

Related devices

The database contains available information from scientific literature that is being updated periodically. Please note that the provided information (as retrieved from analysed papers) is provided only for devices commercially available with CE-IVD mark. Acknowledgements