FDA probes accuracy issue with Abbott's rapid virus test
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U.S. Food and Drug Administration is alerting the public to early data that suggest potential inaccurate results from using the Abbott ID NOW point-of-care test to diagnose COVID-19. Specifically, the test may return false-negative results.

This test can still be used and can correctly identify many positive cases in minutes. Negative results may need to be confirmed with a high-sensitivity authorized molecular test, said FDA.

The test is used daily at the White House to test President Donald Trump and key members of his staff, including the coronavirus task force.

The FDA looks at a variety of sources to identify and understand potential patterns or significant issues with the use of the Abbott test. No diagnostic test will be 100% accurate due to performance characteristics, specimen handling, or user error, which is why it is important to study patterns and identify the cause of suspected false results.

The FDA will keep working with Abbott to further evaluate these accuracy issues and will publicly communicate any updates.

Source: https://health.economictimes.indiatimes.com/news/industry/fda-probes-accuracy-issue-with-abbotts-rapid-virus-test/75751803
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