Abbott gets FDA authorization for new COVID-19 antibody test

Abbott said Oct. 12 it has received emergency authorization from the FDA for a new antibody test that is designed to detect more recent infections. 

The AdviseDx test can detect a COVID-19 antibody called Immunoglobulin M, a sign of more recent infection since the antibody is undetectable weeks or months after infection. 

The lab-based test can help patients determine where they are in their recovery from the virus and help providers determine whether treatment, isolation or follow-up appointments are needed, Abbott said. 

“Abbott has developed tests to detect the virus at each stage of infection, so doctors and their patients are equipped with knowledge of how they are responding to the virus and progressing through recovery,” said Abbott CEO Robert Ford.

The test demonstrated 99.56 percent specificity, so it’s unlikely to find false negatives, as well as 95 percent sensitivity, meaning there’s a 5 percent chance it will give a false positive result.  

Read the full news release here.

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