(Reuters) – The US drug regulator said on Friday that genetic variants of COVID-19, including the one found in the UK, could lead to false negative results from some molecular tests of COVID-19, but the risk of that mutations affect the overall accuracy of the tests is low.
The U.S. Food and Drug Administration (FDA) said it alerted laboratory staff and health care providers of possible false negative results and asked them to consider these results in combination with clinical observations and that they would use a different test if COVID-19 is still suspected to occur. . (bit.ly/3ost0R6)
The most contagious variant of COVID-19 that has swept the UK has been reported in at least five US states, National Institutes of Health Director Francis Collins said this week.
Scientists have said that newly developed vaccines should be equally effective against the new variant.
The combined TaqPath COVID-19 kit from Thermo Fisher Scientific Inc and the Linea COVID-19 test kit from Applied DNA Sciences significantly reduce sensitivity due to certain mutations, including variant B.1.1.7 or the so-called variant of the UK, according to the agency.
However, detection patterns from both tests can help identify new variants early in patients, the FDA said.
The performance of Mesa Biotech’s Accula test may also be affected by genetic variants, the health regulator added.
Mesa said his test would tolerate the genetic variation presented by the new strain and should not affect the clinical performance of the test.
Britain said in December that rapid lateral flow tests being rolled out in the country’s mass testing program could identify the variant, while Roche said its COVID-19 molecular test would not be affected by the strain mutant of the virus.
Reports from Vishwadha Chander to Bengaluru; Edited by Shounak Dasgupta and Devika Syamnath