Rapid Strep A PCR Test Approved for Use Outside Traditional Clinical Labs

A 15-minute diagnostic test for the detection of Streptococcus A (Strep A) in throat cultures that was designed to be run on a user-friendly, automated PCR platform has been granted a CLIA (Clinical Laboratory Improvement Amendments) waiver from the [US] Food and Drug Administration.

The CLIA waiver allows use of the Roche (Basel, Switzerland) cobas Liat System Strep A test in nontraditional laboratory sites, including physician offices, emergency rooms, health department clinics, pharmacy clinics, and other healthcare facilities.

The cobas Liat System is a rapid, easy-to-use, compact PCR platform designed for on-demand testing in point-of-care settings such as physician clinics, pharmacy, and hospital and satellite laboratories. The system is fully-automated with touchscreen guided operation, requiring minimal training and hands-on time. The system includes the cobas Liat Analyzer—a small, benchtop analyzer safeguarded by an extensive array of instrument controls—plus a growing portfolio of assays, including cobas Influenza A/B, cobas Influenza A/B and RSV, and cobas Strep A.

“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 of Roche Diagnostics. “The approximately 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.”

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