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11th January 2021  Author: rapidmicrobiology staff writer

FDA Issues Alert on Mutated Variants Avoiding Detection in COVID-19 Testing

The US FDA has alerted COVID-19 testing labs of false-negatives arising from new variants of SARS-CoV-2 in circulation. 

So far, the FDA has identified three emergency authorized molecular tests, likely to be impacted by genetic variations in the virus. The three tests are Mesa Biotech's Accula SARS-CoV-2 Test, Thermo Fisher Scientific TaqPath COVID-19 Combo Kit and Applied DNA Sciences' Linea COVID-19 Assay Kit. 

The FDA statement issued on Friday 8th January reads: "Tests that rely on the detection of multiple regions of the genome may be less impacted by genetic variation in the SARS-CoV-2 genome than tests that rely on detection of only a single region... Laboratories should expect some false results to occur even when very accurate SARS-CoV-2 tests are used. "

However, the FDA were keen to point out: "The detection pattern that appears with the TaqPath and Linea diagnostic tests when certain genetic variants are present may help with early identification of new variants in patients to reduce further spread of infection. The recently identified B.1.1.7 variant has been associated with an increased risk of transmission, therefore early identification of this variant in patients may help reduce further spread of infection."



Date Published: 11th January 2021

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