Each year approximately 5-20% of U.S. residents get the flu and more than 200,000 people are hospitalized for flu-related complications. The cobas Influenza A/B test offers an effective, new diagnostic tool for the upcoming flu season and enables health care providers to provide faster diagnosis and treatment for patients in primary and urgent care settings, while the patient waits.
The U.S. Food and Drug Administration has granted CLIA waiver for the cobas® Influenza A/B test for use on the cobas® Liat System. It is the first polymerase chain reaction (PCR) test that can be used to detect influenza A and B in non-traditional (CLIA-waived) testing sites, including physician offices, emergency rooms, health department clinics, pharmacy clinics and other health care facilities.
The CLIA waiver expands access to this highly accurate PCR technology—the gold standard in molecular testing—that was previously only available within a laboratory setting.
The cobas Influenza A/B test is the second assay on the cobas Liat System to receive CLIA waiver, following the cobas Strep A test, which received CLIA waiver earlier this year.