Abbott Launches COVID-19 Antibody Test, Plans 20 Mln Tests Per Month by June

By Reuters Staff

April 16, 2020

(Reuters) - Abbott Laboratories Inc said on Wednesday it launched a coronavirus blood test that could show whether a person has been infected and plans to ramp up manufacturing to produce 20 million tests per month by June.

The test helps identify 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 are considered a potential game changer in the battle to contain infections and offers the chance to get the economy back on track by identifying people who may have immunity to the virus and could return to their jobs.

The company said it plans to file for FDA approval for its test through the emergency use pathway.

Last month, the U.S. Food and Drug Administration relaxed the rules on use of diagnostic tests by allowing body-fluid tests to proceed to market without full agency review and approval. (https://reut.rs/2RFgway)

Abbott's test identifies the IgG antibody, a protein the body produces in the late stages of infection and may remain for up to months and possibly years after a person has recovered.

The company expects to immediately ship close to 1 million tests this week to U.S. customers, and will ship a total of 4 million tests for April.

Abbott has previously won U.S. authorization for two 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.

The company also said it would work on expanding its testing to detect the IgM antibody, made by the body a few days after infection.

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