Alere announced the FDA has issued clearance for the Alere i Influenza A & B test, the first molecular test to distinguish influenza A and B virus in less than 15 minutes.

The Alere i Influenza A & B test was validated in a multicenter, prospective study conducted at 8 U.S. trial sites during the 2012–2013 flu season, in which 585 nasal swab specimens were collected from patients presenting with influenza-like syndromes. The specimens were evaluated with Alere i and then compared to viral culture. The Alere i Influenza test showed 97.9% (95% CI: 92.6, 99.4%) sensitivity and 86.2% (95% CI: 82.8%, 89.0%) specificity for influenza A. Regarding influenza B, the Alere i Influenza test showed 92.5% (95% CI : 84.6%, 96.5%) sensitivity and 96.5% (95%CI: 94.5%, 97.8%) specificity.

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Alere’s proprietary Molecular in Minutes (MIM) isothermic nucleic acid amplification technology (iNAT) can deliver PCR-caliber results faster because it does not require thermo cycling or DNA purification.

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