MONDAY, MAY 4, 2020
FDA CLARIFIES THAT NO COVID-19 ANTIBODY TESTS HAVE BEEN AUTHORIZED FOR ADMINISTRATION AT THE POINT-OF-CARE OR IN CLIA-WAIVED LABORATORIES . Today (May 4, 2020), the FDA announced revisions to its March 16, 2020 policy concerning COVID-19 antibody tests. As many pharmacists know, on March 16, the FDA announced a policy of "not objecting" to the introduction of certain COVID-19 antibody tests into the market prior to FDA review of those tests. Since that time, "FDA has become aware that a concerning number of commercial serology tests are being promoted inappropriately, including for diagnostic use, or are performing poorly based on an independent evaluation by the NIH." Accordingly, FDA has clarified its guidance: "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’s updated guidance is found here: https://www.fda.gov/media/135659/download
In a statement accompanying the updated guidance (https://www.fda.gov/news-events/fda-voices/insight-fdas-revised-policy-antibody-tests-prioritizing-access-and-accuracy), FDA emphasized that its original guidance was:
intended to limit antibody testing laboratories certified under [CLIA] by [CMS] to perform testing in high-complexity and point-of-care settings when covered by such certificates – that is, labs with special clinical and technical expertise – as long the tests were properly validated and labeled as outlined in our policy, and the developer notified the FDA. Under CLIA, only those laboratories are allowed to perform tests that have not been FDA authorized. . . . [I]t is not accurate for developers to claim their test was authorized by the FDA if an EUA was not granted for the tests, nor should they be distributing their test if it has not been properly validated.
Board staff have received several inquiries from pharmacies who have received marketing materials for point-of-care COVID-19 antibody tests claiming that they are “FDA authorized.” They are not. At present FDA has not issued an EUA for any COVID-19 antibody test to be administered in a laboratory holding a CLIA waiver. See https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#ivdnote1
Pharmacies that receive marketing pitches for these non-FDA-authorized antibody tests are encouraged to report them to the North Carolina Attorney General’s office: https://ncdoj.gov/covid19/