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FDA-approved point-of-care Influenza and Strep A tests



Following the recent approval of Baloxavir Marboxil for the treatment of acute, uncomplicated influenza (influenza) in patients 12 years of age or older who have not been symptomatic for more than 48 hours, the US Food and Drug Administration (FDA) has called Point Abbott's next generation of-care Influenza A and B 2 and Strep A 2 molecule assays have been shown to improve the fastest time to market among the assays. Both assays also received a CLIA waiver certificate (CLIA).

The Grip Test provides point-of-care molecular detection and Grip A & B A & B differentiation results in 13 minutes or less with a compact memory system that allows for lean testing. The test also allows storage of all test components at room temperature, according to a statement by Abbott that simplifies and streamlines the order and storage of tests.

The Strep A 2 assay, which allows molecular detection of group A Streptococcus . bacterial nucleic acid is able to deliver results within 6 minutes or less. Positive results can be retrieved after just 2 minutes without requiring culture confirmation.

The assays are supported by the ID NOW platform, the first CLIA-based point-of-care platform based on an instrument-based isothermal system for the qualitative detection of infectious diseases. Initial Influenza A & B and Strep An assay for the platform was approved for marketed use in 201

4 and 2015, respectively, with a third Respiratory Syncytial Virus 2016 assay approved.

With FDA Following approval, Abbot now expects to offer new assays for fall.

It has been a particularly busy week for marketed flu therapies with the approval of Baloxavir Marboxil and the updated indication for the quadrivalent flu vaccine to involve pediatric patients. Achieving early use of positive test results with molecular accuracy in such a short time is noisy Gregory J. Berry, Director of Molecular Diagnostics, Northwell Health Laboratories at Lake Success, New York, found a "trailblazing evolution" for treatment purposes

"Rapid testing can also help reduce the abuse of antibiotics that can occur when the treatment is based solely on the patient's symptoms and contributes to antibiotic resistance, "Berry said in a statement.

This article originally appeared as" FDA Approved Fast & Strep Assays "on MD Magazine.com.

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