FDA Emergency Use Authorization COVID-19 Diagnostic Tests

FDA Emergency Use Authorization COVID-19 Diagnostic Tests

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Source: U.S. Food and Drug Administration (FDA)

28. Logix Smart Coronavirus Disease 2019 (COVID-19) kit

Date: April 3, 2020

Company: Co-Diagnostics, Inc.

Indication: Qualitative detection of nucleic acid from SARS-CoV-2 in lower respiratory tract fluids (e.g. bronchoalveolar lavage, sputum, tracheal aspirate), and upper respiratory tract fluids (e.g. nasopharyngeal and oropharyngeal swabs) from individuals who are suspected of COVID-19 by their healthcare provider. Emergency use of this test is limited to authorized laboratories.

Authorized Laboratories: Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.

27. ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit

Date: April 3, 2020

Company: ScienCell Research Laboratories

Indication: Qualitative detection of nucleic acid from the SARS-CoV-2 in nasal, nasopharyngeal/oropharyngeal swab specimens, and bronchoalveolar lavage from individuals suspected of COVID-19 by their healthcare provider. Emergency use of this test is limited to authorized laboratories.

Authorized Laboratories: Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.

26. ARIES SARS-CoV-2 Assay

Date: April 3, 2020

Company: Luminex Corporation

Indication: Qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal swab specimens collected from individuals suspected of COVID-19 by their healthcare provider. Emergency use of this test is limited to authorized laboratories.

Authorized Laboratories: Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 USC §263a, to perform moderate and high complexity tests.

25. BioGX SARS-CoV-2 Reagents for BD MAX System

Date: April 2, 2020

Company: Becton, Dickinson & Company (BD)

Indication: Qualitative detection of nucleic acid from SARS-CoV-2 nasopharyngeal and oropharyngeal swab samples from individuals suspected of COVID-19 by their healthcare provider. Emergency use of this test is limited to authorized laboratories.

Authorized Laboratories: Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate and high complexity tests.

24. COV-19 IDx assay

Date: April 1, 2020

Company: Ipsum Diagnostics, LLC

Indication: Qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal and oropharyngeal swab specimens collected from individuals suspected of COVID-19 by their healthcare provider. Emergency use of this test is limited to authorized laboratories.

Authorized Laboratories: Ipsum Diagnostics, LLC, or other laboratories designated by Ipsum Diagnostics, LLC that are also certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.

23. qSARS-CoV-2 IgG/IgM Rapid Test

Date: April 1, 2020

Company: Cellex Inc.

Indication: Qualitative detection of IgM and IgG antibodies against SARS-CoV-2 in serum, plasma (EDTA or citrate), or venipuncture whole blood from individuals suspected of COVID-19 by their healthcare provider. Emergency use of this test is limited to authorized laboratories.

Authorized Laboratories: Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, to perform moderate and high complexity tests.

22. QIAstat-Dx Respiratory SARS-CoV-2 Panel

Date: March 30, 2020

Company: QIAGEN GmbH

Indication: A multiplexed nucleic acid real-time PCR test intended for the qualitative detection and differentiation of nucleic acid from multiple respiratory viral and bacterial organisms1, including the SARS-CoV-2 virus, in nasopharyngeal swabs (NPS) eluted in universal transport media collected from patients suspected of COVID-19 by their healthcare provider. Emergency use of this test is limited to authorized laboratories.

Authorized Laboratories: Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity and moderate complexity tests.

21. NeuMoDx SARS-CoV-2 Assay

Date: March 30, 2020

Company: NeuMoDx Molecular, Inc.

Indication: Qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal or oropharyngeal swabs, and nasal swabs from individuals suspected of COVID-19 by their healthcare provider. Emergency use of this test is limited to authorized laboratories.

Authorized Laboratories: Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high and moderate complexity tests.

20. ID NOW COVID-19

Date: March 27, 2020

Company: Abbott Diagnostics Scarborough, Inc.

Indication: Qualitative detection of nucleic acid from the SARS-CoV-2 virus in the direct nasal, nasopharyngeal or throat swabs and nasal, nasopharyngeal or throat swabs eluted in viral transport media from individuals who are suspected of COVID-19 by their healthcare provider. Emergency use of this test is limited to authorized laboratories and other authorized testing locations using the ID NOW Instrument.

Authorized Laboratories and Other Authorized Testing Locations: Authorized laboratories – laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high and moderate complexity tests. Other Authorized Testing Locations – patient care settings using the ID NOW Instrument.

19. NxTAG CoV Extended Panel Assay

Date: March 27, 2020

Company: Luminex Molecular Diagnostics, Inc.

Indication: Qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal swab specimens from individuals suspected of COVID-19 by their healthcare provider. Emergency use of this test is limited to authorized laboratories.

Authorized Laboratories: Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 USC §263a, to perform high complexity tests.

18. Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV

Date: March 26, 2020

Company: BGI Genomics Co. Ltd.

Indication: Qualitative detection of SARS-CoV-2 nucleic acids in throat swabs and bronchoalveolar lavage fluid (BALF) from individuals suspected of COVID-19 by their healthcare provider. Emergency use of this test is limited to authorized laboratories.

Authorized Laboratories: Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 USC §263a, to perform high complexity tests.

17. AvellinoCoV2 test

Date: March 25, 2020

Company: Avellino Lab USA, Inc.

Indication: Qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal and oropharyngeal swab specimens collected from individuals suspected of COVID-19 by their healthcare provider.

Authorized Laboratories: Testing is limited to Avellino Lab USA, Inc., which is certified under Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a to perform high complexity tests.

16. PerkinElmer New Coronavirus Nucleic Acid Detection Kit

Date: March 24, 2020

Company: PerkinElmer, Inc.

Indication: Qualitative detection of nucleic acid from the SARS-CoV-2 virus in human oropharyngeal swab and nasopharyngeal swab specimens collected from individuals suspected of COVID-19 by their healthcare provider. Emergency use of this test is limited to authorized laboratories.

Authorized Laboratories: Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.

15. Accula SARS-Cov-2 Test

Date: March 23, 2020

Company: Mesa Biotech Inc.

Indication: Qualitative, visual detection of nucleic acid from the SARS-CoV-2 in throat swab and nasal swab specimens combined, collected from patients suspected of COVID-19 by their healthcare provider. Emergency use of this test is limited to authorized laboratories and other authorized testing locations using the Accula Dock or Silaris Dock.

Authorized Laboratories and Other Authorized Testing Locations: Authorized laboratories – laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high and moderate complexity tests. Other Authorized Testing Locations – patient care settings using the Accula Dock or Silaris Dock.

14. BioFire COVID-19 Test

Date: March 23, 2020

Company: BioFire Defense, LLC

Indication: Qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal swabs in transport media from individuals suspected of COVID-19 by their healthcare provider. Emergency use of this test is limited to authorized laboratories.

Authorized Laboratories: United States (U.S.) laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate complexity tests, and in U.S. laboratories certified under CLIA to perform high complexity tests, or in similarly qualified non-U.S. laboratories.

13. Xpert Xpress SARS-CoV-2 test

Date: March 20, 2020

Company: Cepheid

Indications: Qualitative detection of nucleic acid from the SARS-CoV-2 in:

(1) nasopharyngeal swab and nasal wash/aspirate specimens collected from individuals suspected of COVID-19 by their healthcare provider. Emergency use of this test is limited to use of the GeneXpert Dx and GeneXpert Infinity Systems in authorized laboratories; and

(2) nasopharyngeal swab specimens collected from individuals suspected of COVID-19 by their healthcare provider. Emergency use of this test is authorized to be distributed and used in patient care settings using the GeneXpert Xpress System (Tablet and Hub Configurations).

Authorized Laboratories and Other Authorized Testing Locations: Authorized laboratories – laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high and moderate complexity tests. Other Authorized Testing Locations – patient care settings.

12. Primerdesign Ltd COVID-19 genesig Real-Time PCR assay

Date: March 20, 2020

Company: Primerdesign Ltd.

Indication: Qualitative detection of nucleic acid from SARS-CoV-2 in oropharyngeal swab specimens from patients suspected of COVID-19 by their healthcare provider. Emergency use of this test is limited to authorized laboratories.

Authorized Laboratories: Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.

11. ePlex SARS-CoV-2 Test

Date: March 19, 2020

Company: GenMark Diagnostics, Inc.

Indication: Qualitative detection of SARS-CoV-2 nucleic acid in nasopharyngeal swab specimens (NPS) eluted in viral transport media (VTM) collected from individuals suspected of COVID-19 by their health care provider. Emergency use of this test is limited to authorized laboratories.

Authorized Laboratories: Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high and moderate complexity tests.

10. Simplexa COVID-19 Direct assay

Date: March 19, 2020

Company: DiaSorin Molecular LLC

Indication: Qualitative detection of nucleic acid from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in nasopharyngeal swabs (NPS) from individuals suspected of COVID-19 by their healthcare provider. Emergency use of this test is limited to authorized laboratories.

Authorized Laboratories: Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high and moderate complexity tests.

9. Abbott RealTime SARS-CoV-2 assay

Date: March 18, 2020

Company: Abbott Molecular, Inc.

Indication: Qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal (NP) and oropharyngeal (OP) swabs from patients suspected of COVID-19 by their healthcare provider. Emergency use of this test is limited to authorized laboratories.

Authorized Laboratories: Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.

8. Quest SARS-CoV-2 rRT-PCR

Date: March 17, 2020

Company: Quest Diagnostics Infectious Disease, Inc.

Indication: Qualitative detection of nucleic acid from SARS-CoV-2 in upper and lower respiratory specimens (such as nasopharyngeal or oropharyngeal swabs, sputum, lower respiratory tract aspirates, bronchoalveolar lavage, and nasopharyngeal wash/aspirate or nasal aspirate) from individuals suspected of COVID-19 by their healthcare provider, pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3).

Authorized Laboratories: Quest Diagnostic Laboratories or other laboratories designated by Quest Diagnostics that are also certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, to perform high complexity tests.

7. Lyra SARS-CoV-2 Assay

Date: March 17, 2020

Company: Quidel Corporation

Indication: Qualitative detection of nucleic acid from SARS-CoV-2 nasopharyngeal (NP) or oropharyngeal swab (OP) specimens from patients suspected of COVID-19 by their healthcare provider, pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3).

Authorized Laboratories: United States (U.S.) laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.

6. COVID-19 RT-PCR Test

Date: March 16, 2020

Company: Laboratory Corporation of America (LabCorp)

Indication: Qualitative detection of nucleic acid from SARS-CoV-2 in upper and lower respiratory specimens (such as nasopharyngeal or oropharyngeal swabs, sputum, lower respiratory tract aspirates, bronchoalveolar lavage, and nasopharyngeal wash/aspirate or nasal aspirate) from individuals suspected of COVID-19 by their healthcare provider, pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3).

Authorized Laboratories: Center of Esoteric Testing, Burlington, North Carolina, or other laboratories designated by LabCorp that are also certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.

5. Panther Fusion SARS-CoV-2

Date: March 16, 2020

Company: Hologic, Inc.

Indication: Qualitative detection of nucleic acid from SARS-CoV-2 isolated and purified from nasopharyngeal (NP) and oropharyngeal (OP) swab specimens obtained from individuals who meet COVID-19 clinical and/or epidemiological criteria, pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3).

Authorized Laboratories: United States (U.S.) laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.

4. TaqPath COVID-19 Combo Kit

Date: March 13, 2020

Company: Thermo Fisher Scientific, Inc.

Indication: Qualitative detection of nucleic acid from SARS-CoV-2 in the nasopharyngeal swab, nasopharyngeal aspirate, and bronchoalveolar lavage (BAL) specimens from individuals suspected of COVID-19 by their healthcare provider, pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3).

Authorized Laboratories: United States (U.S.) in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.

3. cobas SARS-CoV-2

Date: March 12, 2020

Company: Roche Molecular Systems, Inc. (RMS)

Indication: Qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal and oropharyngeal swab samples from patients who meet COVID-19 clinical and/or epidemiological criteria, pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3).

Authorized Laboratories: United States (U.S.) in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate complexity tests and in U.S. laboratories certified under CLIA to perform high complexity tests, by clinical laboratory personnel who have received specific training on the use of the cobas 6800/8800 Systems.

2. New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel

Date: February 29, 2020, Revised: March 7, 2020

Company: Wadsworth Center, New York State Department of Public Health

Indication: Qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal/oropharyngeal swabs and sputa collected from individuals who meet Centers for Disease Control and Prevention (CDC) Coronavirus Disease 2019 (COVID-19) clinical and/or epidemiological criteria (for example, clinical signs and symptoms associated with COVID-19, contact with a probable or confirmed COVID-19 case, history of travel to a geographic location where COVID-19 cases were detected, or other epidemiologic links for which COVID-19 testing may be indicated as part of a public health activity).

Authorized Laboratories: Qualified laboratories designated by Wadsworth Center, NYSDOH and, in the United States, certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, to perform high complexity tests.

1. CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel

Date: February 4, 2020, Revised: March 5, 2020

Company: Centers for Disease Control and Prevention (CDC)

Indication: Qualitative detection of nucleic acid from the SARS-CoV-2 in upper and lower respiratory specimens collected from individuals who meet COVID-19 clinical and/or epidemiological criteria (for example, clinical signs and symptoms associated with COVID-19, contact with a probable or confirmed COVID-19 case, history of travel to a geographic location where COVID-19 cases were detected, or other epidemiologic links for which COVID-19 testing may be indicated as part of a public health investigation).

Authorized Laboratories: Testing in the United States is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, to perform high complexity tests.

FDA Emergency Use Authorization COVID-19 Diagnostic Tests

References

  1. U.S. Food and Drug Administration (FDA).

COVID-19 Diagnostic Tests


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