Abbott Laboratories was granted emergency use approval (EUA) by the Food and Drug Administration for a new coronavirus antibody test it says can exclude false positives 99.6% of the time and exclude false negatives 100% of the time.
The EUA means laboratories will be allowed to use the test even though it has not been formally approved or cleared by the FDA. Last week, the FDA tightened rules for coronavirus antibody tests, ordering manufacturers to submit emergency use authorization forms and data proving the tests work within 10 days or face possible removal.
Abbott plans to ship nearly 30 million tests — which can indicate whether a person has had Covid-19 in the past and was either asymptomatic or recovered — in May and will have the capacity to ship 60 million tests in June, the company said in a press release.
