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FDA Expands Emergency Use Authorization for Abbott SARS-CoV-2 Serology Test

This story has been clarified and updated to reflect that a previous EUA was expanded.

NEW YORK – Abbott announced Monday the US Food and Drug Administration expanded the firm's previous Emergency Use Authorization to include the SARS-CoV-2 IgG serology blood test for use with the Alinity i platform. 

The test previously was authorized by the agency for use with Abbott's Architect i1000SR and i2000SR systems. It also received the CE mark last month. Abbott's Architect immunoassay system can run up to 100 to 200 tests in an hour, the company said.   

Abbott said it expects to ship almost 30 million antibody tests globally in May with capacity for 60 million tests in June. The Abbott Park, Illinois-based firm also said it expects to submit the Alinity test for CE mark this week.

The test has greater than 99.6 percent specificity and 100 percent sensitivity in patients tested two weeks after symptoms begin, 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," said President and CEO Robert Ford.