NEW YORK (GenomeWeb) – Alere announced today that it has received 510(k) clearance from the US Food and Drug Administration for a point-of-care isothermal nucleic acid amplification test that detects respiratory syncytial virus infection in children and adults from nasopharyngeal swab samples in 13 minutes or less.
In clinical performance studies, the Alere i RSV test delivered 98.6 percent sensitivity and 98 percent specificity from nasopharyngeal swab samples, and 98.6 percent sensitivity and 97.8 percent specificity from viral transport media samples, Alere said, and the test will be available for use in hospitals in time for the 2016-2017 respiratory season.
The firm will soon submit an application for a CLIA waiver for the RSV test, having already received CLIA waivers for its influenza A and B and strep A tests.
It is the latest test on the Alere i platform, following the release of tests for influenza A and B and Strep A, and it is among the first molecular tests for RSV that can be used at the point of care, according to Alere.
In June 2014, FDA cleared the Alere i molecular platform for the detection and differentiation of influenza A and B virus, and in March of the same year the agency cleared Alere’s strep A test.
Multiple new analytes on the Alere i platform are progressing well through product development, Avi Pelossof, Alere’s global president of infectious disease, said in a statement.