This page provides answers to frequently asked questions related to settings in which SARS-CoV-2 tests may be used.
This section includes questions and answers regarding the policies outlined in the Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff: Policy for Coronavirus Disease-2019 Tests during the Public Health Emergency (Revised). In this section, this guidance is referred to as the Policy for Coronavirus Disease-2019 Tests.
For a directory of FAQs related to SARS-CoV-2 testing, see FAQs on Testing for SARS-CoV-2.
A: Yes. The settings in which an EUA-authorized test may be used are described in the Letter of Authorization. As discussed in the Guidance for Industry and Other Stakeholders: Emergency Use Authorization of Medical Products and Related Authorities, when the FDA issues an EUA for tests for use at the point of care (including SARS-CoV-2 point of care test systems), such tests are deemed to be CLIA waived tests. Accordingly, generally for the duration of the emergency declaration, such tests can be performed in a patient care setting that is qualified to have the test performed there as a result of operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
We note that the term point of care in the EUAs may include settings such as hospitals, physician offices, urgent care, outreach clinics, pharmacies, and temporary patient care settings that have appropriately trained personnel to perform the test and are operating under a CLIA Certificate of Waiver or Certificate of Compliance. These terms generally do not apply to home specimen collection or at home testing unless otherwise specified.
A: Tests on a notification list that are not identified as "Authorized" have not yet been reviewed by the FDA, are not FDA authorized, and have not received a CLIA categorization. Therefore, in accordance with CLIA, tests offered under these policies are considered high complexity by default unless and until they are authorized and deemed to be appropriate, through an EUA authorization or general FDA review processes, to be performed as moderate or waived complexity tests.
Laboratories should be mindful of CLIA requirements, which are enforced by CMS and certain State authorities, and CMS guidance for laboratories during the COVID-19 public health emergency. Under CMS guidance, if a facility has the appropriate CLIA certificates and follows applicable CLIA regulations, state regulations and guidelines, the laboratory's CLIA certificate can be extended to cover testing in areas outside of the designated primary site or home base such as contiguous buildings, or any other designated temporary overflow location in its facility or temporary remote location, such as a parking lot.
A: If you would like to develop and offer a test for use at the point-of-care (POC), please see the EUA templates for recommendations on how to validate the test for this use and submit your EUA request to the FDA. As discussed in the EUA template, an EUA request for a POC test should include data to demonstrate that non-laboratory personnel can perform the test accurately in the intended use environment, as well as data to demonstrate the robustness of the device for near patient testing, i.e., that the device is not sensitive to environmental and usage variation. For assays intended for use with a test system that was previously reviewed and CLIA waived by the FDA, testing is generally only needed to establish the performance of the SARS-CoV-2 assay. If your test system is CLIA waived, please reference the data submitted in a previous CLIA waiver submission in your EUA request (i.e., provide your previous 510(k) or CLIA waiver submission number). In general, since the information provided for the previous CLIA waiver categorization can be leveraged, additional test data may not be needed to demonstrate that the system is simple enough for use at the POC, unless there is a feature of the SARS-CoV-2 assay that would make performing the test more complicated than assays previously cleared for use on the test system.
As discussed in the EUA template, molecular diagnostic POC tests are generally expected to demonstrate positive and negative agreement of ≥ 95%. However, positive agreement of ≥ 80% may be appropriate with appropriate limitations added to the intended use that would mitigate the risk of false negative results. For example, negative results may be considered presumptive negative if the demonstrated PPA is lower than 95%.
The Policy for Coronavirus Disease-2019 Tests explains FDA's regulatory flexibility regarding developers that offer validated diagnostic tests while the developers pursue an EUA from the FDA. Tests being offered prior to an EUA under the policies outlined in the FDA's Policy for Coronavirus Disease-2019 Tests have not yet been reviewed by the FDA, are not FDA authorized, and have not received a CLIA categorization or deemed categorization. Therefore, in accordance with CLIA, tests offered under these policies are considered high complexity by default until or unless they are authorized and deemed to be appropriate, through an EUA authorization or general FDA review processes, to be performed as moderate or waived complexity tests.
A: You can offer your COVID-19 test for testing at home or in other non-laboratory settings, such as offices or schools, if the test is specifically authorized in the EUA to be run in such settings based on data and science to support consumer safety and test accuracy.
As noted in the Policy for Coronavirus Disease-2019 Tests, the policies regarding distributing and offering tests prior to or without an EUA that are outlined in this guidance have never applied to at-home testing, including at-home specimen collection.
FDA has provided an EUA template to help facilitate the preparation and submission of EUA requests, and the authorization of these types of tests. The template includes recommendations about what testing should be performed to demonstrate that a COVID-19 test for home/non-lab use has been validated, recommendations for generally expected performance metrics, and recommendations for demonstrating the ability of lay users to collect their specimen, run the test, and interpret their results accurately. Additionally, this template provides information about what safety considerations should be considered in an EUA request, including safety from any exposure to toxic chemicals that may be used in the reaction. Due to the benefits of broader access to simple and fast testing options from tests that can be performed completely outside of a laboratory, a lower sensitivity of such tests, when compared to tests run in a laboratory, may be appropriate. The FDA is always open to alternative proposals, such as serial testing where the overall sensitivity can be considered cumulatively rather than based on one-time testing, and encourages developers to discuss such proposals with the FDA.
As explained in the template, when FDA receives an EUA request with validation to support consumer safety and test reliability and accuracy for COVID-19 tests for non-laboratory use, FDA will generally evaluate and may issue EUAs for such tests when the criteria for authorization are met. All such authorizations will include, among other conditions, any necessary conditions of authorization to address different risks presented by specimen collection outside healthcare settings versus collection in a healthcare setting, as well as testing and interpreting results by a lay consumer rather than a healthcare professional.
A: You can offer your COVID-19 test for at-home self-collection if at-home self-collection is specifically authorized in the EUA for the test. In addition, COVID-19 tests for at-home self-collection may be used as part of an Institutional Review Board (IRB)-approved study.
The FDA is supportive of at-home self-collection and has authorized various COVID-19 molecular diagnostic tests for home collection of specimens to be sent to a laboratory for processing and test reporting. These authorizations are specific to the home collection kit and test pairs identified in those EUAs. All tests that have received an EUA, including any authorizations for home collection of a specimen, can be found on our Emergency Use Authorizations page. If you are developing a home specimen collection kit or are interested in adding home collection to your authorized assay, we recommend using the Home Specimen Collection Molecular Diagnostic Template to help facilitate the preparation, submission, and authorization of an EUA. We encourage you to reach out to us at CDRH-EUA-Templates@fda.hhs.gov if you wish to discuss an alternate approach.
As noted in the Policy for Coronavirus Disease-2019 Tests, the policies regarding distributing and offering tests prior to or without an EUA that are outlined in the guidance never applied to at-home testing, including at-home specimen collection.
Home collection raises several issues of importance, including whether the lay user can safely and properly collect the specimen, whether the components of the specimen transport media are safe for use in the home environment (since some may be toxic), proper shipment, and adequate stability of the specimen given the time lapse between collection and testing and the potential impact of shipping conditions (such as, if the specimen sits in a hot truck).
A healthcare provider watching the collection by way of telemedicine may address the issue of proper specimen collection (if the self-collection method does not raise safety concerns) but it does not address the other issues, and specimen stability and shipping conditions are still of concern.
To address the concerns regarding specimen stability and shipping conditions for foam or polyester nasal swabs shipped dry (in an empty tube) or in saline (0.9%), FDA has reviewed analytical validation data using clinical specimens from swab stability studies conducted by Quantigen Biosciences, with support from The Gates Foundation and UnitedHealth Group, that can be used, in conjunction with other data from the sponsor, to support sample stability of foam or polyester nasal swabs shipped dry (in an empty tube) or in saline (0.9%) for testing with authorized SARS-CoV-2 molecular diagnostic assays. Quantigen Biosciences has granted a right of reference to any sponsor wishing to pursue an EUA to leverage their COVID-19 swab stability data as part of that sponsor's EUA request. This data addresses specimen stability during shipping. Quantigen Biosciences also performed additional testing, which is described in a publication by Quantigen, to provide data supporting dry swab transport (swabs transported in a tube with no media) and laboratory rehydration of dry swabs using a valid rehydration protocol. This data is also included in Quantigen's right of reference so any sponsor wishing to pursue an EUA can leverage the Quantigen data as part of that sponsor's EUA request. FDA may request additional validation including if, for example, an alternate procedure is being followed for either shipping or rehydration.
Distributors of home collection systems should contact the Pipeline and Hazardous Materials Safety Administration (PHMSA) within the Department of Transportation (DOT) to confirm their packaging and shipping instructions will ensure users are in compliance with the hazardous materials regulations for shipping medical material. PHMSA can be contacted at HMInfo@dot.gov.
A: Each EUA-authorized test has a Letter of Authorization (LOA) and Instructions for Use (or an EUA Summary for tests performed in a single laboratory) available on the In Vitro Diagnostics EUA page. These documents include FDA requirements regarding ordering the test. For example, there is a condition in the LOAs that the manufacturer comply with 21 CFR 809.10(a)(4), which states that, among other things, the label of an in vitro diagnostic product shall include certain references to: (1) "Rx," (2) a statement regarding the restriction to sale by or on the order of a physician, dentist, veterinarian or (3) with the descriptive designation of any other practitioner licensed by the law of the State in which the practitioner practices to use or order the use of the device. As such, State licensing laws may need to be consulted to determine exactly who can use or order an EUA-authorized COVID-19 test.
Tests on a notification list are performed in laboratories certified to perform high-complexity testing. Under CLIA regulatory requirements, such laboratories must have a written or electronic request for patient testing from an individual authorized under State law to order tests and/or receive test results. See 42 CFR 493.1241(a); 42 CFR 493.2. State laws should be consulted to see exactly who can order a COVID-19 test.
A: FDA has issued a number of Emergency Use Authorizations for COVID-19 tests. All COVID-19 tests that are authorized under an EUA can be found on the In Vitro Diagnostics EUA page. Laboratories authorized to use such tests are subject to various conditions that can be found in the EUA.
Each EUA also includes the settings in which the test is authorized. Facilities performing COVID-19 testing must be certified under the Clinical Laboratory Improvement Amendments, or CLIA, which is administered by CMS. For ease of reference, the settings authorized in the EUAs are also noted in the EUA table on the In Vitro Diagnostics EUA page. Tests that are noted with an "H" in the Authorized Settings are limited to use in laboratories certified under CLIA that meet requirements to perform high-complexity tests. Tests that are noted with an "H" and "M" in the Authorized Settings may be performed in laboratories certified under CLIA to perform high complexity and/or moderate complexity tests. Tests that are noted with a "W" in the Authorized Settings are deemed to be CLIA-waived for use in patient care settings operating under a CLIA Certificate of Waiver. Tests noted with an "H," "M," and "W may be used in laboratories certified under CLIA that meet requirements to perform high complexity and/or moderate complexity tests and in patient care settings operating under a CLIA Certificate of Waiver.
Test kits on a notification list that are not identified as "Authorized" have not yet been reviewed by the FDA, are not FDA authorized, and have not received a CLIA categorization. Unless and until an EUA is issued that authorizes additional testing environments for a specific test, under CLIA, use of that test is limited to laboratories certified to perform high complexity testing, and at the point-of-care when covered by the laboratory's CLIA certificate for high-complexity testing.
FDA is not involved in the distribution or allocation of tests. Facilities qualified to offer tests should reach out to their usual purchasers and distributors.