FDA clears Abbott’s assays for influenza and Streptococcus

26 October 2018 (Last Updated October 26th, 2018 10:51)

The US Food and Drug Administration (FDA) has cleared Abbott’s next-generation, point-of-care molecular assays to detect certain strains of influenza and Streptococcus bacteria.

FDA clears Abbott’s assays for influenza and Streptococcus
Group A streptococcus is known to cause bacterial pharyngitis. Credit: National Institute of Allergy and Infectious Diseases, National Institutes of Health.

The US Food and Drug Administration (FDA) has cleared Abbott’s next-generation, point-of-care molecular assays to detect certain strains of influenza and Streptococcus bacteria.

The new Influenza A & B 2 assay has been designed for the molecular identification and differentiation of the influenza A and B virus strains within 13 minutes. Abbott said the assay can display positive results in five minutes.

Abbott developed the Strep A 2 test for the detection of Group A Streptococcus bacterial nucleic acid, which is known to cause bacterial pharyngitis.

“The Abbott molecular assays can be adopted in both inpatient and outpatient settings such as emergency rooms, physician offices, walk-in clinics and urgent care centres.”

This assay is claimed to detect the bacteria twice more rapidly than existing molecular tests, delivering results in six minutes or less, with a call out of positive results in two minutes. Strep A 2 test does not require culture confirmation for negative results.

Abbott Rapid Diagnostics senior vice-president Sharon Bracken said: “These Influenza A & B 2 and Strep A 2 assays combine speed with efficacy for rapid delivery of molecular results, further driving value for healthcare systems where time equals money.

“By delivering fast and accurate molecular results at the point of care, these tests provide physicians with the confidence to give the right diagnosis and the ability to prescribe the right treatment earlier.”

The Abbott molecular assays can be adopted in both inpatient and outpatient settings such as emergency rooms, physician offices, walk-in clinics and urgent care centres.

They are available for use on the ID NOW platform, an isothermal system for the qualitative identification of infectious diseases.

Previous variants of Influenza A & B and Strep A assays for the ID NOW platform were cleared in 2014 and 2015, respectively.