Speedy Strep Test Cleared for Pharmacies
The FDA has cleared Roche's cobas Strep A test for use by health care professionals in non-traditional settings, including pharmacies and physician offices.
The FDA has cleared Roche’s cobas Strep A test for use by health care professionals in non-traditional settings, including pharmacies and physician offices.
Group A Streptococcus bacteria cause approximately 37% of sore throats in children and 5% to 15% in adults. If left untreated, the infection could lead to life-threatening conditions, such as scarlet fever and streptococcal toxic shock syndrome.
Through polymerase chain reaction technology in Roche’s cobas Liat System, the assay can detect Strep A bacteria in throat swab specimens in less than 15 minutes. This will provide prompt diagnosis in a decentralized setting, removing the wait for confirmatory results, Roche stated.
“[The FDA’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 Roche Diagnostics COO Roland Diggelmann in a press release. “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.”
The FDA’s Clinical Laboratory Improvement Amendments (CLIA) waiver for the Strep A test allows its use in physician offices, emergency rooms, health department clinics, pharmacy clinics, and other health care facilities.
Roche has also submitted its cobas Influenza A/B test for CLIA waiver.