FDA has granted waived status under the terms of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for the Cobas Strep A test for use on the Cobas Liat system, by Roche Diagnostics, Basel, Switzerland. The Cobas test is the first CLIA-waived test to detect Strep A in throat swab specimens in approximately 15 minutes.
CLIA waived status 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,” commented Roland Diggelmann, COO at Roche Diagnostics. “The 15-minute turnaround time of the Cobas Strep A test offers a much improved experience for both the patient and the healthcare professional when compared to culture testing, which can take several days for a result.”
Strep A causes about 37% of sore throats among children, and roughly 5% to 15% of sore throats among adults.1,2 Strep A infections are most common among those between the ages of 5 and 15.3
Utilizing polymerase chain reaction technology, 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 to aid a treatment decision are generated in 20 minutes or less. The system will provide greater access for patients to prompt diagnosis in decentralized settings, removing the wait for confirmatory results.
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. For further information, visit the Cobas Liat hompage.
- Shaikh N, Leonard E, Martin JM. Prevalence of streptococcal pharyngitis and streptococcal carriage in children: a meta-analysis. Pediatrics. 2010;126(3):e557–e564; doi: 10.1542/peds.2009-2648.
- Shulman ST, Bisno AL, Clegg HW, et al. Clinical practice guideline for the diagnosis and management of group A streptococcal pharyngitis: 2012 update by the Infectious Diseases Society of America. Clin Infect Dis. 2012;55(10):e86–e102; doi: 10.1093/cid/cis629.
- Strep throat. PubMed Health [online]. Available at: www.ncbi.nlm.nih.gov/pubmedhealth/PMH0001663. Accessed May26, 2015.