The US Food and Drug Administration (FDA) has issued emergency use approval to Swiss drug maker Roche Holding AG for an antibody test to help determine if people have ever been infected with the coronavirus.
Roche, which also makes molecular tests to identify active COVID-19 infections, said its antibody test has a specificity rate of 99.8 percent and a sensitivity rate of 100 percent.
This means the test, called Elecsys Anti-SARS-CoV-2, would show very few false positives and no false negatives.
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