FDA warns new coronavirus variant could trigger false negatives among gold-standard tests

"The FDA is alerting healthcare professionals that mutations in the novel coronavirus’s genetic code—such as the type powering the fast-spreading variant identified in the U.K.—can trigger false negative results in gold-standard COVID-19 tests.
Accuracy can suffer if the alterations occur within the specific region of the virus’s RNA used by molecular diagnostics to line up a positive result, which may vary product to product, the agency said.
While FDA staff said they believe these risks are low, the agency listed three currently authorized tests—Thermo Fisher’s TaqPath combo kit, Mesa Biotech’s hand-held Accula test and Applied DNA Sciences’ Linea assay—that may be compromised by genetic variants.
However, the detection patterns provided by the TaqPath and Linea tests could also help identify new mutated strains of the coronavirus, the FDA said—such as the new B117 variant, which could be 50% more contagious.
Tests that use multiple areas of the coronavirus’s genome to establish a positive match may offer more chances to pick up an accurate result, the agency said..." Lire la suite