October 14, 2015
Pharmacy Clinics Now Can Use Rapid PCR Influenza Tests

Basel, Switzerland—U.S. pharmacy clinics now will be able to offer detection of influenza and Strep A in about 20 minutes or less through real-time polymerase chain reaction (PCR) testing.

For the first time, the FDA has granted a CLIA (Clinical Laboratory Improvement Amendments) waiver for the cobas Influenza A/B test for use on the cobas Liat System. A press release from Roche Diagnostics notes that is the first CLIA-waived PCR test to detect both influenza A and B that quickly.

The company announced that, in conjunction with the CLIA-waived cobas Strep A test, the cobas Influenza A/B test can now be used by healthcare providers in nontraditional testing sites, including pharmacy clinics, physician offices, emergency departments, health department clinics and other healthcare facilities.

“Today’s CLIA waiver for the cobas Influenza A/B test allows real-time PCR technology, the gold standard in molecular testing, to be utilized at the point of care to accurately and quickly detect and differentiate influenza A and B,” said Roland Diggelmann, COO of Roche Diagnostics. “Effective management of influenza relies on accurate detection within 48 hours of onset, which can be challenging with current turnaround times for lab-based test results. The cobas Influenza A/B test provides lab-quality PCR results in ~20 minutes, enabling health care providers in all settings to give prompt and confident diagnosis and treatment to patients.”

The cobas Influenza A/B test targets highly conserved regions of the influenza A and B genomes to provide broad strain coverage of over 30 commonly found strains of influenza A and B, according to Roche. The company’s cobas Liat System uses PCR and fully automates the process.

The cobas Strep A test received the CLIA waiver in May.

Real-time PCR is considered to be highly accurate and offers a low limit of detection (LOD) to detect viruses in patients with low viral load, such as some adults with influenza infection. It also allows for high multiplex testing—such as influenza A, influenza B, and respiratory syncytial virus (RSV) in the same test—quantification of viral load count, and detection, according to the press release. Roche also points out that, compared to physician clinical management, rapid antigen testing and other point-of-care testing methods, real-time PCR has demonstrated improved detection of influenza.
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