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FDA Issues Alert for Clinical Laboratory Staff for Potential False Results with Roche COVID-19 Test

FDA maze of regulations

Roche COVID-19 and influenza combination test may provide false results, FDA warns clinical laboratory staff

The US Food and Drug Administration (FDA) issued an alert for clinical laboratory staff that false-positive results can occur with the Roche Molecular Systems, Inc., (Roche) cobas SARS-CoV-2 and Influenza A/B Nucleic Acid Test for use on the cobas Liat System.

According to the FDA, there are two issues that have been identified that can cause false-positive results with this test:

  1. The assay tubes for this test can sporadically leak, obstructing an optical analyzer. This can produce false positives, particularly for the influenza B test.
  2. According to Roche, “abnormal PCR cycling in the reaction tubes” may lead to false positives for multiple analytes on a single testing run.

The FDA’s alert letter to clinical laboratory staff made the following three recommendations for laboratories using this test:

  1. “Monitor for unexpected clusters of positive Flu B results, as this may indicate the cobas Liat System has experienced a tube leak.”
  2. “Repeat tests when two or three analytes are positive. Different results on the repeat test may indicate abnormal PCR cycling.”
  3. “Stop using the cobas Liat System and contact Roche if you suspect either of these two issues has occurred.”

Clinical laboratorians wishing to view the FDA alert can do so here.

Related Resource:

FDA: Potential for False Results with Roche Molecular Systems, Inc. cobas SARS-CoV-2 & Influenza Test for use on cobas Liat System-Letter to Clinical Laboratory Staff, Point-of-Care Facility Staff, and Health Care Providers