Alere Inc, Waltham, Mass, recently received FDA clearance for its Alere i Strep A test, which detects group A Streptococcus bacteria from throat swab specimens in 8 minutes or less.

The test is performed on the Alere i platform, using isothermal technology that amplifies nucleic acids at a constant temperature. Because thermal cycling and sample purification steps are not required, the test produces fast results. The instrument features a compact footprint, intuitive touchscreen, visual guides, and unidirectional connectivity to the user’s network.

A multicenter study evaluating 481 throat swab specimens demonstrated that the test’s sensitivity is 95.9% while its specificity is 94.6%. A laboratory-developed, real-time polymerase chain reaction (PCR) assay evaluated all samples generating discordant results between assay and bacterial culture. Of the 6 samples negative by the Strep test and positive by bacterial culture, 4 were also negative for group A Streptococcus when evaluated by the real-time PCR assay. Of the 18 samples positive by the Strep test and negative by bacterial culture, 13 were also positive for group A Streptococcus according to the real-time PCR assay.

Upon receipt of its FDA clearance, Alere submitted an application for waived status under the terms of the Clinical Laboratory Improvement Amendments of 1988 (CLIA).

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Avi Pelossof, global president of infectious disease at Alere

“This FDA clearance brings the power of our Alere i molecular platform to the detection of Strep A,” says Avi Pelossof, global president of infectious disease at Alere. “The speed and accuracy of the Alere i Strep A test empower healthcare professionals to initiate the right treatment in an actionable timeframe, which is a critical step in reducing unnecessary prescription of antibiotics and enhancing operational efficiency.”

In 2014, FDA cleared the company’s platform for the detection and differentiation of influenza A and B virus. The first molecular test ever to receive a CLIA waiver, the Alere i influenza A and B test detects and differentiates influenza A and B virus in less than 15 minutes. Other assays currently in development include tests for respiratory syncytial virus and C. difficile, and a combined test for Chlamydia trachomatis and Neisseria gonorrhoeae.

For more information, visit Alere.