FDA revokes another SARS-CoV-2 serology EUA after NCI data suggests poor performance.
On Aug. 7, 2020, the US Food and Drug Administration (FDA) announced the revocation of a second SARS-CoV-2 antibody test emergency use authorization (EUA). The EUA had initially been issued for Autobio Diagnostics Co., Ltd.’s, Anti-SARS-CoV-2 Rapid Test. Autobio Diagnostics is based out of Zhengzhou, China, and had initially obtained the EUA on April 24, 2020.
The EUA revocation was based on research performed by the National Cancer Institute (NCI). The initial IgM sensitivity reported by Autobio Diagnostics was 85.43%, however, data by the NCI indicated an IgM sensitivity of 50%. Autobio Diagnostics, along with their distributor Hardy Diagnostics, proposed multiple test design changes and revisions to the instructions for use, but the FDA ultimately found these proposals inadequate.
The revocation of the Anti-SARS-CoV-2 Rapid Test EUA marks the second time that an EUA for a COVID-19 related test has been revoked. The first EUA revocation occurred on June 16, 2020, and involved the EUA issued for Chembio Diagnostic System, Inc.’s DPP COVID-19 IgM/IgG System, another SARS-CoV-2 antibody test (See Implications of Revocation of SARS-CoV-2 Serology EUA May Indicate FDA Enforcement That Could Affect Clinical Laboratories’ COVID-19 Tests). This EUA was also revoked based on NCI testing data.