The FDA has granted a Clinical Laboratory Improvement Amendments (CLIA) waiver for the cobas Liat PCR System and the cobas Strep A test, the first FDA-cleared device to offer polymerase chain reaction (PCR) technology at the point of care, including doctor’s offices and pharmacies.
Strep A causes about 37 percent of sore throats among children and results in up to 1,800 deaths each year globally. Untreated, it can lead to acute rheumatic fever and post-streptococcal acute glomerulonephritis, which can have severe negative consequences on the health and well-being of infected patients, so faster diagnosis is necessary to properly treat the disease using appropriate antibiotic therapy.
The new technology provides highly accurate lab standard results in about 15 minutes, other rapid tests for Strep A require additional confirmatory testing for negative results, which can take 24 to 48 hours.
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. The analyzer and two initial assays, cobas Influenza A/B and cobas Strep A, are both CE Marked and FDA cleared. The manufacturer, Roche, has also submitted the cobas Influenza A/B test for CLIA waiver.
References:
Shaikh N, Leonard E, Martin JM (September 2010). "Prevalence of streptococcal pharyngitis and streptococcal carriage in children: a meta-analysis". Pediatrics 126 (3): e557–64. doi:10.1542/peds.2009-2648.
Shulman, ST; Bisno, AL; Clegg, HW; Gerber, MA; Kaplan, EL; Lee, G; Martin, JM; Van Beneden, C (Sep 9, 2012). "Clinical Practice Guideline for the Diagnosis and Management of Group A Streptococcal Pharyngitis: 2012 Update by the Infectious Diseases Society of America." Clinical infectious diseases: an official publication of the Infectious Diseases Society of America 55 (10): e86–102. doi:10.1093/cid/cis629.