FDA Approves Emergency Use Authorization of Abbott Labs' Antibody Test

Abbott Laboratories’ new antibody test received emergency use approval from the Food and Drug Administration Monday, the company announced.

In a press release, the company said it has plans to ship 30 million tests this month. 

The antibody blood tests show whether a person has had COVID-19 in the past and was either asymptomatic or recovered.

Abbott said the new test, the "Alinity" system, takes up less space and can provide more testing. The test can exclude false positives 99.6% of the time and exclude false negatives 100% of the time for patients tested 14 days after symptoms began, the company said.

“Having more options of highly reliable tests across our platforms will help healthcare workers and health officials as they conduct broad scale testing for COVID-19,” Abbott CEO Robert Ford said in a statement.

Abbott representatives said they will have the capacity to ship 60 million tests in June.

The FDA approval means labs will be allowed to use the test even though it doesn’t have formal approval or clearance by the FDA. 

Abbott already has received several FDA approvals from coronavirus-related testing, including a rapid test that shows results in about five minutes. 

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