Home » FDA Clears First Coronavirus Antibody Test for Use During Pandemic
FDA Clears First Coronavirus Antibody Test for Use During Pandemic
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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