FDA Approves Covid-19 Antibody Test
The Food and Drug Administration gave emergency approval to a COVID-19 antibody test that boasts near-perfect accuracy, the company said Sunday • Full Story
The Food and Drug Administration gave emergency approval to a COVID-19 antibody test that boasts near-perfect accuracy, the company said Sunday.
Swiss drugmaker Roche said the new test, which determines whether someone had a past infection, has proven 100% accurate at detecting antibodies in the blood and 99.8% accurate at ruling out the presence of them.
The company said the test requires intravenous blood draws, with 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,” Thomas Schinecker, the company’s head of diagnostics, said.
“You have to have very, very high specificity. Even 0.1% or 0.2% makes a difference.”
Schinecker said the tests are an important step in determining whether someone may have immunity, but acknowledged that more research is required to determine whether antibodies protect people from being reinfected.
“Since this virus is not well known, one can hypothesize, but the proof will take longer,” Schinecker said. “Testing these people … is key to seeing whether or not people really have developed immunity.”
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