COVID-19 Omicron Variant Could Cause False-Negative Results In Tide Labs Test, FDA Says
The US FDA said this week that the DTPM COVID-19 RT-PCR Test made by Tide Laboratories LLC could give erroneous readings because of the latest coronavirus variant.
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The US FDA has added the Linea COVID-19 Assay Kit to its list of diagnostics that could produce false-negative results due to the most recent coronavirus mutation.
The Revogene SARS-CoV-2 test from Meridian Bioscience could give false-negative results because of the latest coronavirus variant. The good news is that the diagnostic hasn’t been distributed in the US, the FDA says.
US FDA device center director Jeff Shuren said on 22 July that the agency is worried about the Delta variant, but is taking the steps necessary to ensure that coronavirus diagnostics give accurate readings.