CLIA Waiver for Roche's cobas Liat PCR System and Strep A assay
Roche has been granted CLIA (Clinical Laboratory Improvement Amendments) waiver for the cobas® Strep A test for use on the cobas® Liat System. It is the first CLIA-waived PCR test to detect Strep A in throat swab specimens in ~15 minutes. CLIA waiver allows for broad use of the test by healthcare providers in non-traditional laboratory sites, including physician offices, emergency rooms, health department clinics, pharmacy clinics and other healthcare facilities.
“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,” said Roland Diggelmann, COO, Roche Diagnostics. “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 PCR technology, the cobas Strep A test which is CE Marked and FDA cleared, can detect Strep A DNA obtained from throat swab specimens in ~15 minutes with the cobas Liat System. The cobas Liat System fully automates the testing process, simplifies workflow and enables healthcare professionals to perform molecular testing in a variety of settings with speed, reliability and minimal training. Definitive results are generated in 20 minutes or less to aid a treatment decision. The analyzer and two initial assays, cobas Influenza A/B* and cobas Strep A, are both CE Marked and FDA cleared. Roche has also submitted the cobas Influenza A/B test for CLIA waiver.
Tags: Influenza, Group A Streptococcus
Date Published: May 26, 2015
Source article link: Roche Diagnostics » company contact details
FDA Clearance for Direct Detection of Strep from Throat Swabs
Are You Prepared for the Flu Season Ahead?
New Primer Pairs for LDTs for P. jirovecii, Group C and G Strep
Discover VirClia®, Chemiluminescence in Monotest That Adapts to Your Lab
Flu Season Still to Reach Peak