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FDA Approves COVID-19 Antibody Test that Offers Near-Perfect Accuracy

Virus Outbreak US Testing

The Food and Drug Administration gave emergency approval to a COVID-19 antibody test that provides near-perfect accuracy, the agency announced Sunday.

Swiss drugmaker Roche says the new test, which determines whether someone had a past infection, has proven to be 100 percent accurate at detecting antibodies in the blood and 99.8 percent accurate at ruling out their presence.

The test requires intravenous blood draws, which typically have higher accuracy than finger-prick tests.

“If you take blood from a finger prick, you will never be able to achieve the same level of specificity that you will achieve … when you take blood from the vein,” says Thomas Schinecker, Roche’s head of diagnostics. “You have to have very, very high specificity. Even 0.1% or 0.2% makes a difference.”

Schinecker explains that the tests are an important step in determining whether someone may have immunity. Still, he acknowledges that more research needs to be done in order to determine whether antibodies actually protect people from being reinfected.

“Since this virus is not well known, one can hypothesize, but the proof will take longer,” Schinecker adds. “Testing these people … is key to seeing whether or not people really have developed immunity.”