"Variant COVID-19 May Be Misdiagnosed as Negative, FDA Warns"

Electron microscope image of the novel coronavirus (COVID-19). Photo by Yonhap News.

[Asia Economy Reporter Hana Na] The U.S. Food and Drug Administration (FDA) has warned that variant viruses, including the mutated novel coronavirus infection (COVID-19), may be incorrectly diagnosed as negative in some tests.

On the 8th (local time), the FDA sent a letter to medical professionals and laboratories notifying them that genetically mutated COVID-19, including the UK-origin variant virus B117, may be incorrectly diagnosed as negative in tests, CNN reported.

The FDA explained that any molecular test designed to detect COVID-19 could yield a false negative if mutations occur in the part of the coronavirus genome targeted by the test.

The FDA stated, "Specifically, three tests, including Mesa Biotech's Accula, may be affected by genetic mutations," but added, "The impact appears to be not significant."

It also recommended, "If a negative result is obtained but COVID-19 infection is still suspected, testing should be repeated using a different method."

The FDA said it will continue to monitor genetic mutations of the novel coronavirus to ensure that approved tests provide accurate results to patients.

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