Cepheid declared that clearance has been granted by US FDA 510 (K) waiving clinical laboratory improvement Amendments CLIA for Xpert Xpress Flu test. Performed in near-patient settings, the test provides precise molecular detection of flu A and B RNA from patient specimens in 20 minutes.
The Xpert Xpress Flu Test indicates usage with nasal swabs in combination with nasopharyngeal (NP) swabs. NP swabs are claimed to be more invasive than nasal swabs, therefore, nasal swabs collection permits precision in its specimen collation.
David H. Persing, M.D., Ph.D., Cepheid’s Chief Medical and Technology Officer claimed: “Xpert Xpress Flu is the first highly sensitive PCR test on a CLIA waived multi-module system designed for greater surge capacity and menu versatility.”
World Health Organization states regular usage of antimicrobial usage owing to infections of the upper respiratory tract originating from viral not mandating treatment with antimicrobials.
The test offers access to molecular testing for community hospitals to physician offices and specialty clinics taking into account accuracy, precision, and quality. Xpress Flu test entails real-time reverse transcription polymerase chain reaction (RT-PCR) to detect influenza A and B RNA thus enhancing strain coverage prohibiting loss of sensitivity as natural variations of the influenza virus takes place. The test I itself testifies efficacy, therefore, requiring no additional testing.