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Another Weapon Wins Emergency Approval

Roche says it will be able to produce more than 100 million COVID-19 antibody tests each month
By Bob Cronin,  Newser Staff
Posted May 3, 2020 9:52 AM CDT

(Newser) – For the second time in three days, the Food and Drug Administration has used its emergency powers to approve using a new tool against COVID-19. Roche announced Sunday that it has received the OK for an antibody test, the Wall Street Journal reports. Experts say antibody tests can help them understand how mild and asymptomatic cases of the disease are spreading. The FDA has given emergency approval to other tests, which are conducted on blood samples, that haven't proven sufficiently accurate. The Roche test has been 100% accurate at finding COVID-19 antibodies and 99.8% accurate when showing no antibodies in the blood, the Swiss company said. An executive said that when the blood sample is taken at least 14 days after the person has been infected by the coronavirus, the test is reliable in finding antibodies.

The test kits run on machines that are already in more than 100 labs in the US and ready for immediate use. By the end of the year, per CNBC, Roche said it can turn out more than 100 million tests per month. With other diseases, antibodies can stay in the blood for months or years. The hope for antibody tests is that identifying who has been infected could help governments form containment strategies around immunity, per Reuters. Roche did not announce a price for its antibody test, which it said is more accurate than others because it uses intravenous blood draws. "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," the executive said. (The FDA invoked its emergency powers Friday in allowing the use of an experimental drug.)

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