Abbott Grabs EUA for COVID-19 Antibody Blood Test
Abbott has earned the FDA’s Emergency Use Authorization (EUA) for AdviseDx SARS-CoV-2 IgM, a lab-based serology test.
The antibody test is run on the company’s ARCHITECT and Alinity platforms and is most useful in detecting recent infections. The test is now available on those two systems and is the seventh Abbott COVID-19 test to receive an EUA, according to the company.
In evaluations of its test, Abbott found that it provided 99.56 percent specificity and 95 percent sensitivity for patients tested 15 days after symptom onset.