Danaher : Unit's SARS-CoV-2 IgG Antibody Test Gets FDA Emergency Use OK

By Colin Kellaher

Danaher Corp.'s Beckman Coulter unit on Monday said its Access SARS-CoV-2 IgG assay received U.S. Food & Drug Administration emergency-use authorization.

Beckman Coulter said it has already shipped tests to more than 400 hospitals, clinics and diagnostics laboratories in the U.S., and that it has begun distribution of the new antibody tests globally.

The company said it is able to deliver more than 30 million tests a month.

Beckman Coulter said the test, which detects IgG antibodies directed to the receptor binding domain of the spike protein of the novel coronavirus, has shown 100% positive percent agreement and 99.6% negative percent agreement, significantly reducing the risk for false positives.

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