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Abbott SARS-CoV-2 Antibody Test Nabs FDA EUA

NEW YORK – The US Food and Drug Administration announced Sunday it has granted Emergency Use Authorization to Abbott Laboratories' SARS-CoV-2 IgG antibody test.

The qualitative test detects IgG antibodies in human serum, including and plasma. It uses the SARS-CoV-2 IgG Reagent kit with the SARS-CoV-2 IgG Calibrator kit on Abbott's Architect i1000SR and i2000SR systems. 

Abbott's two-step test uses chemiluminescent microparticle immunoassay technology and it can help identify people with an adaptive immune response to the virus, indicating prior infection. The test can be performed by CLIA-certified moderate and high complexity laboratories.

Abbott now has three tests for the coronavirus that have received FDA EUA, including two molecular tests. Abbott announced the serology test earlier this month and said it plans to ship 4 million serology tests in April. To date, FDA has issued EUAs for eight coronavirus serology tests.