May 11, 2020 / 5:46 PM / 3 months ago

U.S. FDA authorises use of Abbott's COVID-19 antibody test on second system

(Reuters) - The U.S. Food and Drug Administration on Monday authorised the emergency use of Abbott Laboratories’ coronavirus test for detecting antibodies using another of its diagnostic platforms, which will allow the company to ship nearly 30 million tests this month.

Earlier, the company had permission to run the antibody test on its Architect platform. The authorization now allows Abbott to use the test on its Alinity platform.

Abbott also said it could have capacity for shipping 60 million antibody tests across the world in June, which included tests on its Architect system, for which it gained authorization last month.

Alinity systems are designed to run more tests in less space and minimize human errors, Abbott said.

The test identifies disease-fighting antibodies in people who have been infected but may have had mild symptoms or none at all, making it different from the current diagnostic tests that require nasal swabs to confirm active infection.

Antibody tests, however, are not recommended as the sole basis of diagnosis of COVID-19 as these antibodies may not be detected in the early days of the infection.

Such tests are considered crucial in efforts to get Americans back to work safely as the presence of antibodies to the virus indicates possible immunity to future infection.

Abbott has previously won U.S. authorization for two other coronavirus testing kits: an automated test that can be used in labs and a test that can deliver results within minutes and be used in physicians’ offices, clinics and hospitals.

Reporting by Manas Mishra in Bengaluru; Editing by Shailesh Kuber

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