(Reuters) – US drug regulators said on Friday that genetic variants of COVID-19, including one found in the UK, could lead to false negative results in some molecular COVID-19 tests, but the risk of mutations affecting accuracy overall test performance is low.
The US Food and Drug Administration (FDA) said it has alerted laboratory staff and healthcare providers to possible false-negative results and asked them to consider such results in combination with clinical observations and use a test. different if COVID-19 is still suspected. (Bit.ly/3ost0R6)
The most contagious variant of COVID-19 that has crossed the UK has been reported in at least five US states, said this week the director of the National Institute of Health Francis Collins.
Scientists have said that newly developed vaccines should be just as effective against the new variant.
Thermo Fisher Scientific Inc.’s TaqPath COVID-19 combo kit and Applied DNA Sciences COVID-19 test kit were shown to have significantly reduced sensitivity due to certain mutations, including variant B.1.1.7 or the so-called British variant , according to the agency.
However, the detection models of both tests can help identify new variants early in patients, the FDA said.
The performance of the Mesa Biotech Accula test may also be affected by genetic variants, the health regulator added.
Mesa stated that his test will tolerate the genetic variation presented by the new strain and should not have an impact on the clinical performance of the test.
The UK said in December that rapid side-flow tests in the country’s mass testing program could identify the variant, while Roche said its molecular test for COVID-19 was unlikely to be affected by the mutant strain of the virus. .
Report by Vishwadha Chander in Bengaluru; Editing by Shounak Dasgupta and Devika Syamnath