Point-of-Care Influenza and Strep A Assays Approved by FDA

On the heels of the recent approval of baloxavir marboxil for the treatment of acute uncomplicated influenza (flu) in patients 12 years of age and older who have been symptomatic for no more than 48 hours, the US Food and Drug Administration (FDA) has cleared next-generation point-of-care influenza A & B 2 and Strep A 2 molecular assays from Abbott that have been shown to improve on the fastest time to results among marketed assays. Both assays were also granted a Clinical Laboratory Improvement Amendments (CLIA) certificate of waiver.

The flu assay offers a point-of-care molecular detection and flu A & B differentiation result in 13 minutes or less, with a compact storage system that allows streamlined tests. The test also allows for room temperature storage of all test components, according to a statement from Abbott, simplifying and streamlining test ordering and storage.

The Strep A 2 assay, which provides a molecular detection of Group A Streptococcus bacterial nucleic acid, is capable of providing results in 6 minutes or less. Positive results can be called out in as early as 2 minutes, with no culture confirmation required.

The assays are supported by the ID NOW platform, the first CLIA-waived point-of-care molecular platform, with an instrument-based isothermal system for the qualitative detection of infectious diseases. The initial flu A & B and Strep A assays for the platform were approved for marketed use in 2014 and 2015, respectively, with a third assay indicated for respiratory syncytial virus was cleared 2016.

With the FDA approval, Abbot now anticipates offering new assays for use this fall.

It has been a particularly busy week for marketed flu therapies with the baloxavir marboxil approval and updated indication for the quadrivalent flu vaccine to include pediatric patients

The ability to obtain early call outs for positive test results with molecular accuracy in such short time is a “game-changing development” for treatment purposes, according to Gregory J. Berry, PhD, director of Molecular Diagnostics, Northwell Health Laboratories in Lake Success, New York.

“Rapid testing may also help reduce improper antibiotic usage, which can occur when treatment is based exclusively on a patient's symptoms, and contributes to antibiotic resistance,” said Berry in a statement.

This article originally appeared as, “FDA Approves Rapid Flu & Strep Assays,” on MD Magazine.com.