Biohit SARS-CoV-2 antibody test kit cleared by FDA

2020 06 17 20 35 0417 Covid 19 Antibody 400

Biohit Healthcare has received U.S. Food and Drug Administration (FDA) emergency use authorization for its SARS-CoV-2 immunoglobulin M (IgM)/immunoglobulin G (IgG) antibody test kit.

In a study conducted by researchers at Yale University, the test kit produced 100% sensitivity and 97.6% specificity for IgM, as well as 100% sensitivity and specificity for IgG, according to the company. Biohit said that more than six million of these test kits are in the pipeline and will be ready for delivery within a few days.

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