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FAQs on Diagnostic Testing for SARS-CoV-2

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Clinical Laboratory FAQs
Q: I am offering my own test under the new policy outlined in the Policy for Diagnostics Testing for Coronavirus Disease-2019. Do I report all my results as presumptive?
A: Under the policy outlined in the Policy for Diagnostics Testing for Coronavirus Disease-2019, the first five positive and first five negative results should be reported as presumptive and confirmed by an EUA authorized test. If all ten of these results are confirmed by an EUA authorized test, confirmatory testing for subsequent results is not recommended in the guidance.

Q: I am a clinical laboratory certified to perform high-complexity testing under CLIA. I have developed a SARS-CoV-2 test and want to begin accepting patient samples. What should I do?
A: Please refer to the Policy for Diagnostics Testing for Coronavirus Disease-2019.

The FDA encourages such laboratories developing tests to consider the validation recommendations in the guidance as they seek to validate their tests. If you pursue an alternate approach, we recommend discussing plans with us early, through the pre-EUA program. Please contact us at [e-mail].

As noted in the guidance, once your test is validated and you are ready to begin clinical testing, labs should notify the FDA at [e-mail] and provide the name of the lab, lab director, address, and contact person. In the guidance, we recommend that you confirm the first five positive and the first five negative samples with an EUA-authorized test and include in your test report a statement that the FDA review of the validation is pending.

As stated in the guidance, the FDA does not intend to object to the use of validated tests for specimen testing for a reasonable period of time after validation while the laboratory is preparing an EUA request. The FDA believes 15 business days is a reasonable period of time to prepare an EUA submission for a test that has already been validated.

We strongly encourage laboratories testing under this policy to contact their state public health department as early as possible in the process (perhaps even before receipt of any orders or samples) to help ensure they have capacity for the validation testing described in the guidance and have the information necessary to support case investigations. We also encourage laboratories to be sure they are familiar with state and local laws mandating reporting of diseases and conditions of public health significance.

Q: I am a clinical laboratory certified to perform high-complexity testing under CLIA. Do I need an EUA if I purchase a CDC-qualified lot of SARS-CoV-2 test kit reagents and follow the CDC's protocol?
A: No, you do not need your own EUA if you use reagents from a lot that has been qualified by the CDC and follow the CDC's EUA-authorized protocol. Testing using the CDC's EUA-authorized protocol and CDC-qualified lots of reagents is considered to be testing done under the CDC's EUA. Labs performing such testing under the CDC's EUA should be aware of any applicable conditions set forth in the EUA.

Currently, reagents qualified by the CDC are being sold through:

Integrated DNA Technologies (IDT): https://www.idtdna.com/pages/landing/coronavirus-research-reagentsExternal Link Disclaimer
Biosearch Technologies: https://www.biosearchtech.com/products/pcr-kits-and-reagents/pathogen-detection/2019-ncov-cdc-probe-and-primer-kit-for-sars-cov-2External Link Disclaimer
Q: I am a clinical laboratory certified to perform high-complexity testing under CLIA. Do I need an EUA if I purchase a CDC-qualified lot of SARS-CoV-2 test kit reagents and develop my own protocol?
A: Yes. Laboratories that wish to develop their own protocol should refer to the streamlined EUA policy outlined in the Policy for Diagnostics Testing for Coronavirus Disease-2019.

FDA encourages laboratories to discuss their plans with us early, through the pre-EUA program. Please contact us at [e-mail].

Q: I am a clinical laboratory certified to perform high-complexity testing under CLIA and am interested in developing a SARS-CoV-2 test. What do I need to do if I make my own primers/probes or order the individual components?
A: Please refer to the Policy for Diagnostics Testing for Coronavirus Disease-2019.

The FDA encourages such laboratories developing tests, whether using purchased components or making their own primers/probes, to consider the validation recommendations in the guidance as they seek to validate their tests. If you pursue an alternate approach, we recommend discussing plans with us early, through the pre-EUA program. Please contact us at [e-mail].

As noted in the guidance, once your test is validated and you are ready to begin clinical testing, labs should notify the FDA at [e-mail] and provide the name of the lab, lab director, address, and contact person. In the guidance, we recommend that you confirm the first five positive and the first five negative samples with an EUA-authorized test and include in your test report a statement that the FDA review of the validation is pending.

As stated in the guidance, the FDA does not intend to object to the use of validated tests for specimen testing for a reasonable period of time after validation while the laboratory is preparing an EUA request. The FDA believes 15 business days is a reasonable period of time to prepare an EUA submission for a test that has already been validated.