First Test to Accurately Detect Influenza A and B in Under 15 Minutes

Rapid diagnostics with increased sensitivity are essential for enabling healthcare professionals to make more effective decisions. The "Alere i Influenza A & B" test from Alere (Waltham, MA, USA) provides highly accurate, rapid molecular results via the simple, user-friendly "Alere i" platform.

“Alere i is a transformational platform that allows healthcare professionals to make a rapid influenza diagnosis and effective patient management decisions in a clinically meaningful timeframe, whether the patient is in the physician office, emergency department, or urgent care clinic,” said Avi Pelossof, Alere Global President of Infectious Disease. “Alere i also significantly expands screening opportunities by making innovative, rapid molecular testing technology available at the point of care as well as in laboratory settings.”

The proprietary technology utilizes isothermal nucleic acid amplification technology (iNAT), which, unlike polymerase chain reaction (PCR) testing, does not require temperature cycling and can therefore deliver results more quickly ("Molecular-In-Minutes" (MIM)) and to a broader range of settings.

Alere i Influenza A & B delivers actionable, lab-accurate results. Its clinical performance was established in a multicenter, prospective study conducted at 8 US trial sites during the 2012-2013 respiratory season. A total of 571 prospective nasal swab specimens, collected from patients presenting with influenza-like symptoms and representing a wide range of ages, were evaluated with Alere-i Influenza A & B and compared to viral culture. All discrepant samples were tested on an FDA-cleared RT-PCR assay at a central testing laboratory to confirm influenza status. Performance vs. culture discrepant results resolved by RT-PCR were: Influenza A: resolved sensitivity – 99.3%, resolved specificity – 98.1%; Influenza B: resolved sensitivity – 98.9%, resolved specificity – 99.6%.

Alere i Influenza A & B is now commercially available in Austria, France, Spain, Switzerland, Germany, Italy, and the UK. It is currently not available in the USA pending completion of regulatory review by the US Food and Drug Administration (FDA).

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