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FDA clearance for rapid influenza test

Alere has received confirmation that the US Food and Drug Administration (FDA) has cleared the Alere Influenza A&B test for the US market. This highly sensitive, rapid test is intended for use at the point of care and will help practitioners manage patients with influenza-like illness more effectively.

The Alere Influenza A&B test uses highly sensitive antibodies to detect influenza types A and B antigen. When compared to viral culture, the new test showed sensitivity/specificity of 93.8/95.8% for influenza A, and 77.4/98% for influenza B. Sample collection for the Alere Influenza A&B test, which makes use of a nasal swab, is minimally invasive. The test also provides results in 10 minutes, making it possible for clinicians to administer treatment while patients are still in their care.

The Alere Influenza A&B test adds a dipstick format test to the company’s existing portfolio of influenza diagnostics, which includes the card format BinaxNOW Influenza A&B test, enabling Alere to provide primary care physicians with a full range of easy-to-use, effective tools for identifying influenza A & B at the point of care.

www.alere.com

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