Roche Diagnostics is a pioneer in creating innovative medicines and diagnostic tests that help millions of patients globally. The U.S. Food and Drug Administration (FDA) recently granted CLIA (Clinical Laboratory Improvement Amendments) waiver for Roche’s cobas® Strep A test for use on the cobas® Liat System. CLIA (Clinical Laboratory Improvement Amendments) is a lab testing quality standard that is required for any laboratory that performs tests on “materials derived from the human body” for diagnostic, treatment, and health assessment or prevention purposes.
Cobas Strep A is the first molecular PCR test to deliver laboratory quality results in 15 minutes. With the CLIA waiver, the test is now available for use in non-traditional laboratory sites including physician offices, emergency rooms, health department clinics, pharmacy clinics and other healthcare facilities.
With polymerase chain reaction (PCR) technology in Roche’s cobas Liat System, this assay can detect Strep A bacteria in throat swab specimens in less than 15 minutes. According to 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 healthcare professional when compared to culture testing, which can take several days for a result.”
Roche reports that Group A Streptococcus bacteria cause about 37% of sore throats among children and 5-15% in adults. Left untreated, the infection could lead to life-threatening conditions, such as scarlet fever and streptococcal toxic shock syndrome.
Roche’s product line also includes other quality lab equipment such as Roche Cobas Mira – a random access chemistry analyzer, AVL 9180 – an electrolyte analysis system, and Roche Elecsys 2010 Immunoassay Analyzer. This manufacturer has also submitted its cobas Influenza A/B test for CLIA waiver.