FDA Issues Alert for Roche’s COVID-19/Flu Test
The FDA has warned of potential false-positive results from Roche’s cobas SARS-CoV-2 and Influenza A/B nucleic acid test, which runs on the company’s cobas Liat system.
The agency noted that Roche has identified two issues that may be behind the false-positive results: assay tubes that may sporadically leak and abnormal polymerase chain reaction (PCR) cycling in the test’s reaction tubes.
Users running the test should watch for unexpected clusters of positive Flu B results, which may indicate a tube leak, and should repeat tests when two or three analytes are positive, the agency said. Different results on the repeat test could indicate abnormal PCR cycling. If either of these two issues occur, users should stop using the test system and contact Roche, the FDA said.