FDA approves near-perfect anti-coronavirus antibody test


The Food and Drug Administration has urgently approved an almost perfect COVID-19 antibody test, the company said on Sunday.

Swiss drug maker Roche said the new test, which determines whether someone has ever had an infection, was 100% accurate at detecting antibodies in the blood and 99.8% accurate at excluding their presence.

The company said the test requires intravenous blood samples, with higher accuracy than finger prick tests.

“If you take blood on a finger prick, you can never achieve the same level of specificity that you will get … when you take blood in the vein,” said Thomas Schinecker, the company’s diagnostic manager.

“You have to have a very, very high specificity. Even 0.1% or 0.2% makes the difference. “

Schinecker said testing is an important step in determining if someone can have immunity, but acknowledged that more research is needed to determine if antibodies protect people from re-infection.

“Since this virus is not well known, we can speculate, but the proof will take longer,” said Schinecker. “Testing these people … is essential to see if people have really developed immunity.”

With post wires


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