Abbott's coronavirus antibody test gets FDA's emergency use approval
The test detects the IgM antibody, which differs from the IgG
Abbott Laboratories said Monday it was granted emergency use approval by the Food and Drug Administration (FDA) for a coronavirus antibody test that can signal a recent or prior infection of COVID-19.
The AdviseDX test, which detects the Immunoglobulin M (IgM) antibody in a blood sample, differs from another Abbott test which looks for the IgG antibody.
The IgM antibody is used to determine whether someone had a recent COVID-19 infection, as it becomes undetectable after several weeks, whereas an IgG antibody remains detectable in the body for a longer period of time.
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“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,” Robert B. Ford, the company’s president and chief executive officer, said in a press release Monday. “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.”
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The company said the AdviseDx test has demonstrated a 99.56% specificity and 95% sensitivity for patients tested 15 days after symptoms began.
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Abbott has had seven other tests receive emergency use authorization during the coronavirus pandemic, according to Reuters, which allows for the use of unapproved medical products in an emergency to diagnose, treat or prevent serious or life-threatening diseases with no adequate or approved alternatives.