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