FDA Approves Abbot’s COVID-19 Antibody Test for Second System
The U.S. Food and Drug Administration (FDA) Monday authorised the emergency use of Abbott Laboratories’ coronavirus test for detecting antibodies utilizing another of its diagnostic platforms, which will enable the company to ship nearly 30 million tests this month.
Earlier, the company had clearance to run the antibody test on its Architect platform. The authorization now permits Abbott to employ the test on its Alinity platform.
Abbott also stated it might have the capacity for shipping 60 million antibody tests the world over in June, which included tests on its Architect system, for which it gained authorization in April.
Alinity systems are created to run more tests in less space and minimize human errors, Abbott stated.
The test identifies disease-fighting antibodies in people who have been infected; however, it may have had delicate symptoms or none at all, making it different from the current diagnostic exams that require nasal swabs to confirm lively infection.
Antibody tests, nonetheless, are not advisable as the sole basis of the diagnosis of COVID-19 as these antibodies might not be detected in the early days of the infection.
Such tests are deemed crucial in attempts to get Americans back to work safely as the presence of antibodies to the virus signifies possible immunity to future infection.
Abbott has previously won U.S. authorization for two different coronavirus testing kits: an automated test that can be employed in labs and a test that can deliver outcomes inside minutes and be utilized in physicians’ offices, clinics and hospitals.