FDA clears text

FDA Clears First Coronavirus Antibody Test for Use During Pandemic

April 2, 2020

The FDA has awarded Cellex an Emergency Use Authorization for its qSARS-CoV-2 IgG/IgM rapid diagnostic test, the first coronavirus antibody test to receive the authorization.

The test detects IgG and IgM antibodies in the blood of patients suspected to have COVID-19 but is limited to use in authorized laboratories.

The FDA said that based on the evidence the company presented, “it is reasonable to believe that [the] product may be effective in diagnosing COVID-19” despite certain risks it didn’t elaborate on.

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