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