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Abbott SARS-CoV-2 Antibody Test Receives FDA Emergency Use Authorization

NEW YORK – Abbott Laboratories announced Monday its SARS-CoV-2 IgM antibody test has received Emergency Use Authorization from the US Food and Drug Administration.

The AdviseDx SARS-CoV-2 IgM serology test is for use on the firm's Architect and Alinity platforms. The test has shown nearly 100 percent specificity and 95 percent sensitivity in patients 15 days after symptom onset, the company said in a statement.

The company first developed an IgG blood test, the longer-lasting antibody after infection. In contrast, the IgM antibody is best for determining if a patient has had a recent infection, as the antibodies become undetectable in the months after an infection, Abbott said. IgG testing can "play a key role" in understanding if someone has recovered from the virus, along with contract tracing and epidemiological studies, the company added. IgM testing, meanwhile, can help clinicians decide if treatment, isolation, or additional follow-up visits are necessary.

"Antibody tests will continue to play an important role to better understand the virus, the prevalence of COVID-19 in an area and where a patient may be in their recovery," Abbott President and CEO Robert Ford said in the statement.

Abbott's SARS-CoV-2 IgG antibody test received EUA in April.