Certain COVID-19 Serology/Antibody Tests Should Not Be Used by Clinical Laboratory Staff and Health Care Providers

https://www.fda.gov/medical-devices/letters-health-care-providers/certain-covid-19-serologyantibody-tests-should-not-be-used-letter-clinical-laboratory-staff-and?utm_campaign=2020-06-19%20Certain%20COVID-19%20Serology%2FAntibody%20Tests%20Should%20Not%20Be%20Used&utm_medium=email&utm_source=Eloqua

Certain COVID-19 Serology/Antibody Tests Should Not Be Used - Letter to Clinical Laboratory Staff and Health Care Providers

The U.S. Food and Drug Administration (FDA) recommends that clinical laboratories and health care providers stop using COVID-19 antibody tests listed on FDA’s “removed” test list.  The “removed” test list includes: tests where significant clinical performance problems were identified that cannot be or have not been addressed by the commercial manufacturer in a timely manner, tests for which an Emergency Use Authorization request has not been submitted by a commercial manufacturer of a serology test within a reasonable period of time as outlined in the FDA’s guidance, and tests voluntarily withdrawn by the respective commercial manufacturers.

Read More The Letter to Clinical Laboratory Staff and Health Care Providers provides important information about the COVID-19 serology/antibody tests now on FDA’s “removed” test list. It includes: Details about why certain tests were added to the list. Recommendations for how health care providers and clinical laboratories should handle tests that are still within their stock and to evaluate whether patients should be retested using an FDA-authorized test. Instructions for reporting problems with COVID-19 tests. Questions? If you have questions about COVID-19 serology/antibody tests on the “removed” test list, contact COVID19DX@fda.hhs.gov.