FDA issues alert for false positive Covid results with widely used Roche PCR cobas rapid test for Covid and flu-AP, Modern Healthcare, 3/12/21
3/12/21, “The Latest: US health officials warn of false positives,” AP
“The Food and Drug Administration issued the alert on Friday [March 13] for health facilities using Roche’s [PCR] cobas test for coronavirus and seasonal flu.”
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3/12/21, “FDA warns of potential false positive results with Roche Cobas rapid coronavirus, flu test,” Genomeweb via Modern Healthcare
“The US Food and Drug Administration released a letter on Friday warning clinical laboratory and point-of-care staff, as well as healthcare providers, that false positive results for Roche’s [PCR] test for SARS-CoV-2 and influenza A/B may occur….
Roche’s test received Emergency Use Authorization from the FDA in September [2020] for use in moderate- or high-complexity labs and at the point of care. The test uses nasal swabs to differentiate viral nucleic acid from SARS-CoV-2 and influenza A and B and can return results in 20 minutes….
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Added: AP article
March 12, 2021, “The Latest: US health officials warn of false positives,” AP
“U.S. health officials are warning health professionals about the risk of false positive results with a widely used [PCR] laboratory test for COVID-19 and flu.
The Food and Drug Administration issued the alert on Friday [March 13] for health facilities using Roche’s [PCR] cobas test for coronavirus and seasonal flu.”
The agency warned that problems with the test’s processing tubes could result in false diagnosis in people who are not actually infected.
Roche’s testing system is widely used to screen large batches of patient samples in hospitals and laboratories.
The FDA recommends health workers test samples multiple times to help assure accuracy. If the test delivers conflicting results it may indicate a problem and use should be discontinued, the agency says.”
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