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  7. In Vitro Diagnostics EUAs - Molecular Diagnostic Tests for SARS-CoV-2
  1. COVID-19 Emergency Use Authorizations for Medical Devices

In Vitro Diagnostics EUAs - Molecular Diagnostic Tests for SARS-CoV-2

March 24, 2023 - The FDA has finalized two guidances: Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency and Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19). The guidances outline the FDA's general recommendations to transition from certain policies adopted and operations implemented during the COVID-19 pandemic to normal operations, including the FDA's recommendations for:

  • Developing a transition implementation plan,
  • Submitting a marketing submission, and
  • Taking other actions with respect to these devices.

The FDA encourages stakeholders to review the two final guidances, view the webinar, and reach out to the FDA if they have questions or concerns. In particular, for manufacturers planning to seek marketing authorization for their devices, the FDA recommends beginning work on a marketing submission, including a transition implementation plan, as described in the guidances.

Additional Resources:

In Vitro Diagnostic EUAs: Overview and Templates

On This Page:

Individual EUAs for Molecular Diagnostic Tests for SARS-CoV-2

The table below includes information about authorized SARS-CoV-2 molecular diagnostic tests. These emergency use authorizations (EUAs) have been issued for each individual test with certain conditions of authorization required of the manufacturer and authorized laboratories. Test attributes are listed in the "Attributes" column. For example, tests authorized for the screening of asymptomatic individuals without known exposure are listed with "screening" in the attribute column; pooling, multi-analyte, saliva, home collection, and home testing are similarly listed. Tests available without a prescription include the attribute "DTC" (for direct-to-consumer home collection tests) or "OTC" (for over-the-counter at-home tests). To see additional authorization documents, such as letters granting EUA amendments or revisions, and a list of other brand names authorized under a specific EUA, select the plus (+) button beside the "Date EUA Issued or Last Updated" for the EUA.

For information on test EUAs that have been revoked see Historical Information about Device Emergency Use Authorizations: In Vitro Diagnostics (IVD).

In addition to COVID-19 tests issued EUAs, there are molecular SARS-CoV-2 diagnostic tests that have been authorized through traditional premarket review pathways.

Tests with "single target" in the attribute column are:

  • designed to detect only one viral target on the SARS-CoV-2 genome;
  • more susceptible to changes in performance due to viral mutations, meaning they are more likely to fail to detect new variants.

Tests with "multiple targets" in the attribute column are:

  • designed to detect two or more viral targets, or sections of the SARS-CoV-2 genome;
  • more likely to continue to perform well when new variants emerge.

EUAs for standalone specimen collection devices, including home collection kits which do not include an assay in the EUA, will not have a target designation in the attribute column.

Authorized Molecular Diagnostic Tests for SARS-CoV-2 are assigned the QJR product code.

Authorized Home Collection Kits are assigned the QLW product code. Authorized EUAs for Multi-analyte Respiratory Panel Tests are assigned the QLT product code.

1 Authorized settings include the following:

  • H - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests.
  • M - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform moderate complexity tests.
  • W - Patient care settings operating under a CLIA Certificate of Waiver.

2 Authorization Documents include the Healthcare Provider (HCP) and Patient Fact Sheets and either the Manufacture Instructions/Package Insert (abbreviated to IFU) or the EUA Summary.

3 Abbreviations:

  • RT-PCR = reverse transcriptase polymerase chain reaction;
  • RT = reverse transcriptase;
  • LAMP = loop-mediated isothermal amplification;
  • MALDI-TOF = Matrix Assisted Laser Desorption/Ionization - Time of Flight;
  • TMA = Transcription Mediated Amplification;
  • qSTAR = Selective Temperature Amplification Reaction;
  • CRISPR = clustered regularly interspaced short palindromic repeats;

Revision Concerning Viral Mutations

On September 23, 2021, the FDA revised the EUAs of certain molecular, antigen, and serology tests to establish additional Conditions of Authorization in response to the continued emergence of new variants of SARS-CoV-2. The revision requires test developers to update their authorized labeling and evaluate the impact of SARS-CoV-2 viral mutations on their test's performance as outlined in the letter. This revision is effective as of September 23, 2021 for all EUAs that are within the scope of the revision. This revision does not apply to EUAs for authorized IL-6 assays or standalone specimen collection devices and does not apply to EUAs that include substantially equivalent viral mutation conditions of authorization.

The FDA has determined that establishing additional conditions is necessary to mitigate the potential risk of false negative results due to either decreased sensitivity or non-reactivity associated with SARS-CoV-2 viral mutations. As set forth in the September 23, 2021 letter, developers of authorized tests that are within the scope of the revision are now required to routinely monitor emerging viral mutations and their potential impact on the performance of the authorized SARS-CoV-2 test(s).  If potential impacts are identified, the EUA holder must communicate with the FDA and end users about the potential risk that presence of the mutations may have on test performance. The EUA holder must also update their authorized labeling consistent with the revision letter and submit the labeling to the FDA within 3 months of September 23, 2021. By taking these steps, the FDA and the test developer can quickly act in response to the potential risks identified and, when applicable, share the findings on SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests. 

Pooling and Serial Testing Amendment for Certain Molecular Diagnostic Tests for SARS-CoV-2

On April 20, 2021, the FDA issued an amendment allowing certain authorized molecular diagnostic SARS-CoV-2 tests to be distributed and used to pool anterior nasal respiratory specimens from asymptomatic individuals as part of a serial testing program after developers submit a complete notification, including meeting required validation data, as set forth in the letter. Use of tests for these indications is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests, except that tests authorized for use in specific named or designated high complexity laboratories can only be used in such laboratories.

This means that tests with EUAs that are amended by this authorization may be used with pooled anterior nasal specimens from individuals without known or suspected COVID-19 when such individuals are tested as part of a testing program that includes testing at regular intervals, at least once per week. The indications in each appendix (A-H) differ in the number of specimens that can be pooled (up to 3, up to 5, or up to 10) and the type of pooling that can be done (media pooling or swab pooling).

Prior to a test being distributed or used for any new indication, the developer must submit a notification to the FDA with the information required by the amendment, including self-certifying that the applicable validation has been completed. Tests will be added to Exhibit 1 once FDA confirms that the required documentation has been submitted. Please note that being added to Exhibit 1 does not necessarily mean that the FDA has reviewed the underlying validation data submitted or confirmed that the test is appropriately validated.

Exhibit 1 of the Pooling and Serial Testing Amendment

The table below includes information for the authorized RT-PCR molecular diagnostic tests for SARS-CoV-2 amended by this Pooling and Serial Testing Amendment. For authorization documents for each test, see Individual EUAs for Molecular Diagnostic Tests for SARS-CoV-2 above.

* The indications in each appendix (A-H) differ in the number of specimens that can be pooled (up to 3, up to 5, or up to 10) and the type of pooling that can be done (media or swab pooling). 

Tests authorized for Swab Pooling are authorized for:

  • Qualitative detection of RNA from SARS-CoV-2 in pooled samples containing up to [3, 5, or 10, depending on the applicable appendix] individual human anterior nasal swabs placed in a single vial containing transport media after being collected by a healthcare provider (HCP) or self-collected under the supervision of an HCP from any individual, including individuals without symptoms or other reasons to suspect COVID-19, when tested at least once per week as part of a serial testing program.

    This indication is authorized for use in laboratories certified under CLIA to perform high complexity tests except tests authorized for use in specific named or designated laboratories can only be used in such laboratories.

Tests authorized for Media Pooling are authorized for:

  • Qualitative detection of RNA from SARS-CoV-2 in pooled samples containing aliquots of transport media from up to [3, 5, or 10, depending on the applicable appendix] individual human anterior nasal swab specimens that were collected by a healthcare provider (HCP) or self-collected under the supervision of an HCP from any individual and placed in individual vials containing transport media, including individuals without symptoms or other reasons to suspect COVID-19, when tested as part of a serial testing program including testing at least once per week.

    This indication is authorized for use in laboratories certified under CLIA to perform high complexity tests except tests authorized for use in specific named or designated laboratories can only be used in such laboratories.

Umbrella EUA for SARS-CoV-2 Molecular Diagnostic Tests for Serial Testing

On November 15, 2021, the FDA issued an umbrella EUA for certain RT-PCR molecular-based tests, developed by laboratories, for detection of nucleic acid from SARS-CoV-2 from anterior nasal respiratory specimens for use as part of a serial testing program, that meet certain criteria for eligibility specified in the EUA. Under this EUA, authorized tests can be used with individual or pooled anterior nasal specimens for testing individuals, including individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least once per week. This means that tests authorized by this EUA may be used with individual or pooled anterior nasal respiratory specimens from individuals with or without known or suspected exposure to COVID-19 when such individuals are tested at least once per week, such as testing at regular intervals as part of a testing program implemented by schools, workplaces, or community groups. The indications in each appendix (A-K) differ in the number of specimens that can be pooled (1, up to 3, up to 5, or up to 10), the type of pooling that can be done (media pooling or swab pooling), and whether the test can be used with home collected specimens.

Use of tests authorized by this EUA is limited to use in the single laboratory that developed the authorized test and that is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, and meets requirements to perform high complexity tests. 

Tests will be added to Exhibit 1 of this EUA following submission of a complete notification to the FDA with the information required by the EUA, including self-certifying that the applicable validation has been completed, and confirmation by the FDA that the required documentation has been submitted. Being added to Exhibit 1 does not necessarily mean that the FDA has reviewed the underlying validation data submitted or confirmed that the test is appropriately validated.

Exhibit 1 of the Umbrella EUA for SARS-CoV-2 Molecular Diagnostic Tests for Serial Testing

This exhibit includes information for the RT-PCR molecular diagnostic tests for SARS-CoV-2 authorized by this umbrella EUA for SARS-CoV-2 Molecular Diagnostic Tests for Serial Testing. All tests authorized by this umbrella EUA are required to have at least two viral targets on the SARS-CoV-2 genome. Tests with multiple targets are more likely to continue to perform well when new variants emerge.

* All tests authorized under this Umbrella EUA are authorized for (as described in appendix A):

  • Qualitative detection of RNA from SARS-CoV-2 in individual human anterior nasal swab samples collected by a healthcare provider (HCP) or self-collected under the supervision of an HCP from individuals, including individuals without symptoms or other reasons to suspect COVID-19, when tested at least once per week.
     
    Each test is authorized for use in the single laboratory that developed the authorized test and that is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, and meets requirements to perform high complexity tests.

Additional indications included in appendices (B-K) differ in the number of specimens that can be pooled (up to 3, up to 5, or up to 10), the type of pooling that can be done (media or swab pooling), and the inclusion of use with home collected specimens. 

Tests authorized for Swab Pooling (appendices B-D) are authorized for:

  • Qualitative detection of RNA from SARS-CoV-2 in individual human anterior nasal swabs or pooled samples containing up to [3, 5, or 10, depending on the applicable appendix] individual human anterior nasal swabs placed in a single vial after being collected by a healthcare provider (HCP) or self-collected under the supervision of an HCP from individuals, including individuals without symptoms or other reasons to suspect COVID-19, when tested at least once per week.
     
    This test is authorized for use in the single laboratory that developed the test and that is certified under CLIA and meets requirements to perform high complexity tests.

Tests authorized for Media Pooling (appendices E-I) are authorized for:

  • Qualitative detection of RNA from SARS-CoV-2 in individual human anterior nasal swabs or pooled samples containing aliquots of media from up to [3, 5, or 10, depending on the applicable appendix] individual human anterior nasal swab specimens that were collected by a healthcare provider (HCP) or self-collected under the supervision of an HCP from individuals, including individuals without symptoms or other reasons to suspect COVID-19 and placed in individual vials when tested at least once per week.
     
    This test is authorized for use in the single laboratory that developed the test and that is certified under CLIA and meets requirements to perform high complexity tests.

Tests authorized for Home Specimen Collection (appendices J-K) are authorized for the applicable above indications with the following addition regarding specimen collection:

  • {or self-collected at home using the following authorized home collection kit(s): [specific named home collection kit(s) with which the test was validated] when used consistent with the home collection kit's authorization for individuals tested at least once per week}

** Authorization Documents include the Test Summary, Fact Sheet for Healthcare Providers (HCP) and Fact Sheet for Patients.

EUA for Molecular Diagnostic Tests for SARS-CoV-2 Developed And Performed By Laboratories Certified Under CLIA To Perform High Complexity Tests

On March 31, 2020, the FDA issued an umbrella EUA for molecular laboratory developed tests (LDTs) for detection of SARS-CoV-2 that meet certain criteria for eligibility described in the EUA. Under this EUA, authorized tests are authorized for use in the single laboratory that developed the authorized test and that is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests.  Tests authorized under this umbrella EUA were added to Appendix A in the table below. 

On November 15, 2021, the FDA reissued this EUA such that only tests that are listed in Appendix A are authorized for use as described in the EUA, and no additional tests will be authorized by this EUA.  The reissued EUA also includes updated Conditions of Authorization and Fact Sheets to reflect the most up-to-date information.

Appendix A: Authorized Molecular-Based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2

The table below includes information for the high complexity molecular-based laboratory developed SARS-CoV-2 assays authorized by this EUA during the COVID-19 public health emergency.  

To see additional authorization documents, such as letters granting EUA amendments or revisions, for a specific test, select the plus (+) button beside the "Date Last Updated" for each test.

All tests in this table are multiple target tests unless noted with an asterisk (*). Multiple target tests are designed to detect two or more viral targets, or sections of the SARS-CoV-2 genome. Tests with an asterisk are single target tests. Single target tests are designed to detect only one viral target on the SARS-CoV-2 genome. Tests with multiple targets are more likely to continue to perform well when new variants emerge. Tests with single targets are more susceptible to changes in performance due to viral mutations, meaning they are more likely to fail to detect new variants.

All authorized devices in the table below are assigned the QJR product code.

1 The tests listed in this table are all molecular-based tests for COVID-19 and the authorized setting is for use in the identified laboratory that is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.

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