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FDA Grants Emergency Use Authorizations for Access Bio, Truvian Sciences Coronavirus Antibody Tests

NEW YORK — The US Food and Drug Administration has granted separate Emergency Use Authorizations (EUAs) for SARS-CoV-2 antibody tests developed by Access Bio and Truvian Sciences.

Access' CareStart COVID-19 IgM/IgG SARS-CoV-2 test is an immunochromatographic lateral flow assay designed to detect immunoglobulin M and G antibodies against SARS-CoV-2 in human serum, plasma, and venous whole blood, according to the Somerset, New Jersey-based company. Results are provided in 10 minutes. The test may be performed by any lab CLIA-certified to perform moderate- or high-complexity tests, the FDA said.

Earlier this month, Access Bio received EUA from the FDA for its CareStart COVID-19 MDx RT-PCR test for SARS-CoV-2. 

Truvian's Easy Check COVID-19 IgM/IgG antibody test is designed to detect immunoglobulin M and G antibodies against the virus in blood samples. Results are provided in 10 minutes with 98.4 percent sensitivity and 98.9 percent specificity, according to San Diego-based Truvian.