FDA sends January 8th warning stated that a new strain of the coronavirus could cause a false negative result in a molecular COVID-19 test.
The agency said false negatives could occur in the COVID-19 molecular test if mutations occurred in the part of the coronavirus genome used by the test to detect infection.
At least 52 cases of the COVID-19 variant were first discovered in the UK has been identified in the US Another variant first discovered in South Africa has been detected in several cases in the UK, France, Switzerland, Japan, Austria and Zambia.
The FDA said it was working with test developers and evaluating all official molecular tests to see how effective they were against the COVID-19 variant, and said they believed the risk the variants would affect the overall testing accuracy was low.
“While these efforts continue, we are working with official test developers and reviewing incoming data to ensure that healthcare providers and clinical staff can quickly and accurately diagnose patients infected with SARS-CoV-2, including those with an emerging genetic variant. . At this time, we believe the data show that the currently approved COVID-19 vaccine may still be effective against this strain. The FDA will continue to inform healthcare providers and the public about new information as it becomes available, “said FDA commissioner Stephen Hahn, MD.
Tests that use multiple regions of the viral genome may be less affected by the mutated strain than tests that use only one region, the FDA said.
The agency named three specific tests – MesaBiotech Accula, TaqPath COVID-19 Combo Kit, and Linea COVID-19 Assay Kit – as potentially affected by the COVID-19 variant, but said the impact appeared insignificant. The FDA also said that the detection patterns the TaqPath and Linea tests use when certain genetic variants are present in the coronavirus could actually help identify new variants of the virus earlier, which would help reduce the spread of infection.
Read the full FDA warning here.
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