Table 2

Commercial molecular diagnostic tests that received EUA from the Food and Drug Administration of the USA as listed on their website at the time of this review. The website should be checked regularly for updates. (https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations%23covid19ivd)

Date EUA was issuedManufacturerDiagnostic (letter of authorisation)Fact sheet for healthcare providersFact sheet for patientsManufacturer instructions/package InsertOther documents
2 April 2020Becton, Dickinson & Company BioGX SARS-CoV-2 Reagents for BD MAX System Healthcare providers Patients IFU None
1 April 2020Ipsum Diagnostics, LLC COV-19 IDx Assay Healthcare providers Patients EUA summary None
1 April 2020Cellex* qSARS-CoV-2 IgG/IgM Rapid Test Healthcare providers Patients IFU None
30 March 2020QIAGEN GmbH QIAstat-Dx Respiratory SARS-CoV-2 Panel Healthcare providers Patients IFU None
30 March 2020NeuMoDx Molecular NeuMoDx SARS-CoV-2 Assay Healthcare providers Patients IFU None
27 March 2020Luminex Molecular Diagnostics NxTAG CoV Extended Panel Assay Healthcare providers Patients IFU None
27 March 2020Abbott Diagnostics Scarborough ID NOW COVID-19 Healthcare providers Patients IFU None
26 March 2020BGI Genomics Co Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV Healthcare providers Patients IFU None
25 March 2020Avellino Lab USA AvellinoCoV2 test Healthcare providers Patients EUA summary None
24 March 2020PerkinElmer PerkinElmer New Coronavirus Nucleic Acid Detection Kit Healthcare providers Patients IFU Letter granting EUA amendment(s) (1 April 2020)
23 March 2020Mesa Biotech Accula SARS-Cov-2 Test Healthcare providers Patients IFU None
23 March 2020BioFire Defense, LLC BioFire COVID-19 Test Healthcare providers Patients IFU None
20 March 2020Cepheid Xpert Xpress SARS-CoV-2 Test Healthcare providers Patients IFU for labs
IFU for point of care 		None
20 March 2020Primerdesign Primerdesign Ltd COVID-19 genesig Real-Time PCR Assay Healthcare providers Patients IFU None
19 March 2020GenMark Diagnostics ePlex SARS-CoV-2 Test Healthcare providers Patients IFU None
19 March 2020DiaSorin Molecular LLC Simplexa COVID-19 Direct Assay Healthcare providers Patients IFU Letter granting EUA amendment(s) (26 March 2020)
18 March 2020Abbott Molecular Abbott RealTime SARS-CoV-2 Assay Healthcare providers Patients IFU Letter granting EUA amendment(s) (1 April 2020)
17 March 2020Quest Diagnostics Infectious Disease Quest SARS-CoV-2 rRT-PCR Healthcare providers Patients IFU Letter granting EUA amendment(s) (26 March 2020)
17 March 2020Quidel Corporation Lyra SARS-CoV-2 Assay Healthcare providers Patients IFU Letter granting EUA amendment(s) (23 March 2020)
16 March /2020Laboratory Corporation of America COVID-19 RT-PCR Test Healthcare providers Patients EUA summary None
16 March 2020Hologic Panther Fusion SARS-CoV-2 Healthcare providers Patients IFU None
13 March 2020Thermo Fisher Scientific TaqPath COVID-19 Combo Kit Healthcare providers Patients IFU Letter granting EUA amendment(s) (24 March 2020)
12 March 2020Roche Molecular Systems cobas SARS-CoV-2 Healthcare providers Patients IFU Letter granting EUA amendment(s) (31 March 2020)
29 February 2020Wadsworth Centre, New York State Department of Public Health's (CDC) New York SARS-CoV-2 Real-Time Reverse Transcriptase (RT )-PCR Diagnostic Panel Healthcare providers Patients IFU Letter granting EUA amendment(s) (15 March 2020)
4 February 2020CDCCDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel (CDC) Healthcare providers Patients IFU Letter granting EUA amendment(s) (30 March 2020)

  • Authorization Documents include the Healthcare Provider (HCP) and Patient Fact Sheets and either the Manufacture Instructions/Package Insert (abbreviated to IFU)

  • *Antibody rapid test.

  • CDC, Centers for Disease Control and Prevention; EUA, emergency use approval.