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10/29/2018

Abbott unveils next-gen point-of-care testing for flu, strep

The Food and Drug Administration has cleared Abbott’s s next-generation Influenza A & B 2 and Strep A 2 molecular assays for point-of-care testing. Both assays are available on the ID NOW platform, formerly Alere i.

The enhanced flu assay offers the fastest point-of-care molecular detection and differentiation of influenza A and B virus available — in 13 minutes or less, with early call out of positive results in as little as five minutes — allows for room temperature storage of all test components, simplifying and streamlining test ordering and storage, according to the company.

The strep A 2 test provides molecular detection of group A streptococcus bacterial nucleic acid, the primary cause of bacterial pharyngitis, or sore throat, more than twice as rapidly as other available molecular tests — in six minutes or less, with call out of positive results as early as two minutes — with no culture confirmation required for negative results, the company 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," Abbott Rapid Diagnostics senior vice president Sharon Bracken said in a statement. "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 ability to obtain early callouts for positive test results with molecular accuracy in as little as five minutes for influenza and two minutes for strep A is a game-changing development that allows prompt treatment decisions at the point of care," Lake Success, N.Y.-based Northwell Health Laboratories director of molecular diagnostics Gregory Berry said. "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."

The new assays are available in outpatient and inpatient settings, including emergency rooms, physician offices, walk-in clinics and urgent care centers.
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