New test receives FDA clearance

 

Alere Inc. has announced its Alere™ i RSV test received 510(k) marketing clearance from the FDA.

Respiratory syncytial virus is similar to a cold, and highly contagious. The Alere i RSV test can test the virus in under 13 minutes. It detects the virus through nasopharyngeal (NP) swab samples using Alere's proprietary Molecular In Minutes™ isothermal nucleic acid amplification technology.

“Our innovative Alere i platform now allows for the rapid molecular detection of RSV, Influenza A & B and Strep A,” said Avi Pelossof, Alere Global President of Infectious Disease. “The availability of clinically meaningful results in an actionable timeframe empowers clinicians to deliver prompt and appropriate patient care.”

In studies, the Alere i RSV swab test was more than 98% accurate.

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