Switzerland-based Roche has received clinical laboratory improvement amendments (CLIA) waiver from the US Food and Drug Administration (FDA) for its cobas Strep A test to use on the cobas Liat System.
Roche noted that the assay is the first CLIA-waived PCR test to detect Strep A in throat swab specimens in around 15 minutes.
CLIA waiver allows healthcare providers to use the test in non-traditional laboratory sites, including physician offices, emergency rooms, health department clinics, pharmacy clinics and other healthcare facilities.
Roche Diagnostics COO Roland Diggelmann said: "Today’s decision allows the cobas Strep A test to be utilized in clinical settings that previously relied on rapid antigen technology, which is less sensitive and often requires confirmatory testing.
"The ~15-minute turnaround time of the cobas Strep A test offers a much improved experience for both the patient and the health care professional when compared to culture testing, which can take several days for a result."
Using polymerase chain reaction (PCR) technology, the cobas Strep A test will detect Strep A DNA obtained from throat swab specimens in around 15 minutes with the cobas Liat System. It received both CE mark and FDA approval.
The PCR technology allows the cobas Liat System to automate the testing process and enables healthcare professionals to carry out molecular testing in a variety of settings with speed, reliability and minimal training.