The U.S. Food and Drug Administration (FDA) said the DTPM COVID-19 RT-PCR test from Tide Laboratories is now expected to detect the SARS-CoV-2 Omicron variant (B.1.1.529), so the agency has reissued an emergency use authorization (EUA) for the test.
“The original test was a single target test that was expected to fail to detect the SARS-CoV-2 Omicron variant (B.1.1.529) due to a nine-nucleotide deletion in the N-gene, spanning positions 28370-28362, which is within the portion of the N-gene that the single target covered,” the FDA explained. However, the manufacturer has since modified the test, which is now a multiplex test with an added reverse primer to detect the omicron variant.
A bioinformatics analysis demonstrated a 100% match with Omicron and Delta variant sequences, the FDA said.
