The Food and Drug Administration (FDA) has issued a statement regarding the use of serological tests to identify individuals who have overcome infection with coronavirus disease 2019 (COVID-19).
In the statement, FDA Commissioner Stephen M. Hahn, MD noted that while these tests can detect the body’s immune response to the virus, they should not be used for the sole purpose of diagnosing COVID-19 infection, as they do not detect the virus itself. Serological tests are beneficial in that they can help determine who no longer is susceptible to the infection as well as who may be a candidate for convalescent plasma donation.
Recently, the FDA issued an Emergency Use Authorization to Cellex Inc. for its serological test qSARS-CoV-2 IgG/IgM Rapid Test. The test is authorized for use on serum, plasma or venipuncture whole blood specimens from people suspected of COVID-19. It measures human SARS-CoV-2 antibodies, IgM and IgG that are generated as part of the human immune response to the virus. Its use, however, is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform moderate and high complexity tests.
Since March, when the Agency updated its guidance on diagnostic testing, over 70 developers have notified the FDA regarding the availability of serological tests. One major concern, Hahn pointed out, is that some of these companies are making false claims related to authorizations and capabilities. “The FDA will take appropriate action against firms making false claims or marketing tests that are not accurate and reliable,” he warned. Healthcare professionals and consumers are urged to report any fraudulent test kits by sending an email to FDA-COVID-19-Fraudulent-Products@fda.hhs.gov.
A list of diagnostic agents that have been issued Emergency Use Authorization are available here.
For more information visit fda.gov.