New warnings about the strain variant of SARS-CoV-2

The US Food and Drug Administration (FDA) warns that new strains of the SARS-CoV-2 virus can cause false negative at low rates.

The US Food and Drug Administration (FDA) has issued additional warnings about new strains of the SARS-CoV-2 virus, including those found in the UK. According to this warning, viral strain variables can affect the performance of some nucleic acid assays and cause false negatives.

FDA sends this information to the employees of the clinical laboratory and health care provider. False negative results can occur with any nucleic acid assay. The FDA asks them to review these results, combine clinical observations and may retest if there is suspicion that a person with Covid-19 is suspected.

Analysis from the FDA showed that the performance of the three trials (which were approved for emergency use) was affected by strains of SARS-CoV-2. However, the impact is considered insignificant.

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The FDA warns that a new strain of the nCoV virus could cause false but insignificant negatives. Photo: FMT.

According to the agency, the Thermo Fisher Scientific Inc’s TaqPath Covid-19 combination kit and the Linea Covid-19 assay kit significantly reduced susceptibility to strain variables, including B.1.1.7 from the UK. According to the health regulator, Mesa Biotech’s Accula SARS-CoV-2 test performance could also be affected by genetic strains.

However, FDA also believes that the risk of these strains affecting test accuracy is quite low.

In the past week, the director of the National Institutes of Health Francis Collins said that the new strain of the virus with a rapid spread has spread from the UK to at least five US states. The newly developed vaccine will be as effective as the new strains of the virus, the scientists confirmed. Meanwhile, the vaccine maker Pfizer / BioNTech did experiments and said their drugs could fight the new strain of virus.


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