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# Chembio Covid-19 Antibody Test Authorization Revoked
- URL: https://www.fdaweb.com/chembio-covid-19-antibody-test-authorization-revoked/
- Published: 2020-06-17T12:00:00.000Z
- Updated: 2026-09-14T16:18:34.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5147031

FDA has [revoked the emergency use authorization](https://www.fda.gov/media/139109/download?ref=fdaweb.com) of Chembio Diagnostic System’s antibody test, DPP Covid-19 IgM/IgG System, due to performance concerns with the accuracy of the test. The serological test, which is intended to assess a person’s exposure to Covid-19, was one of the first antibody tests authorized by FDA during the public health emergency. “At the time of authorization, based on the information that Chembio submitted to the FDA at that time, the agency concluded that the test met the statute’s ‘may be effective’ standard for emergency use authorization, and that the test’s known and potential benefits outweighed its known and potential risks,” an [FDA release](https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-revokes-emergency-use-authorization-chembio-antibody-test?ref=fdaweb.com) says. “Data submitted by Chembio as well as an independent evaluation of the Chembio test at NCI showed that this test generates a higher than expected rate of false results and higher than that reflected in the authorized labeling for the device. Under the current circumstances of the public health emergency, it is not reasonable to believe that the test may be effective in detecting antibodies against SARS-CoV-2 or that the known and potential benefits of the test outweigh the known and potential risks of the test, including the high rate of false results.”