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Abbott Wins U.S. Emergency Use Authorization for New COVID-19 Antibody Test | Top News

(Reuters) – Abbott Laboratories said on Monday the U.S. Food and Drug Administration has issued an emergency use authorization for its lab-based COVID-19 antibody blood test.

The test, AdviseDx, can be used to identify a type of antibody called Immunoglobulin M (IgM) in blood samples to determine if someone has been exposure to the novel coronavirus, potentially indicating a recent or prior infection.

Abbott has already received emergency use authorization for seven tests, including molecular tests, a rapid antigen test and another test which can detect a type of antibody called IgG.

The FDA’s emergency use authorization allows 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.

IgG is longer lasting in the body after an infection, but IgM is more useful for determining a recent exposure to the coronavirus as these antibodies become undetectable weeks to months following an infection, Abbott said http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20201012:nPn8KFxtXa.

Unlike molecular tests, which can detect whether someone has the coronavirus, antibody tests determine if someone has had a previous infection by detecting disease-fighting proteins called antibodies.

However, antibody tests are not recommended as the sole basis of diagnosis of COVID-19 as these antibodies may not be detected in the early days of the infection.

Shares of Abbott were up 0.5% at $110.21 in early trading.

(Reporting by Manojna Maddipatla in Bengaluru; Editing by Amy Caren Daniel)

Copyright 2020 Thomson Reuters.

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Abbott says new data shows rapid COVID-19 test used at White House is highly accurate

By Manojna Maddipatla and Carl O’Donnell

(Reuters) – Abbott Laboratories on Wednesday released early data from a study on the accuracy of its ID NOW COVID-19 test, which is used in the White House, that could help alleviate concerns the diagnostic frequently fails to detect the virus.

Interim data from Abbott’s 1,003-participant study shows that its test, which can deliver results in under 15 minutes, correctly identified positive COVID-19 cases 95% of the time when used within seven days of symptom onset.

The U.S. Food and Drug Administration issued an emergency use authorization for the test in March, but said in May that early data suggested it could sometimes fail to detect the virus in sick patients. Abbott said it would conduct multiple studies of the test in a variety of healthcare settings.

U.S. President Donald Trump, his wife Melania and several members of the White House staff have contracted COVID-19, raising questions about whether Abbott’s test was reliable enough to be used as the White House’s daily screening tool.

A study conducted by Cleveland Clinic in April showed the test detected the virus in around 85% of cases, lower than many other COVID-19 tests. Other studies, including one by New York University, raised similar concerns.

The FDA said it had received 302 “adverse event” reports as of Sept. 30, including numerous accounts of false negatives – results showing people were not infected when they actually were.

Rapid tests such as Abbott’s are generally less accurate than molecular diagnostic tests, which are the industry gold standard but must be sent to a laboratory to produce results, a process that often takes several days.

Rapid tests are also seen as essential tools to help schools and businesses reopen and stay open.

The latest results confirm the data submitted to the FDA in March that won emergency use authorization for the test, Abbott said. (https://refini.tv/2GLCVA4)

Abbott said it has so far shipped more than 12 million ID NOW tests to all 50 states.

(Reporting by Manojna Maddipatla in Bengaluru; Editing by Saumyadeb Chakrabarty and Bill Berkrot)

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