Alere, a provider of diagnostic products, has received 510(k) marketing clearance from the FDA on its Alere i RSV test, which is capable of detecting respiratory syncytial virus (RSV) infection in children and adults in minutes.
The I RSV test was made to provide care in a fast and accurate for early care, avoiding unnecessary antibiotics and quickly administering care to the infections to prevent the spread of these highly infectious diseases. Detecting the RSV virus through nasopharyngeal swab samples, with Alere's Molecular In Minute isothermal nucleic acid amplification technology, the i RSV is able to give results in 13 minutes or less.
"Our innovative Alere i platform now allows for the rapid molecular detection of RSV, Influenza A and 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. We are excited to continue our ground-breaking innovation on this platform with multiple new analyses progressing well through product development."
In tests on sensitivity and specificity, the Alere i RSV using direct NP swab samples was 98.6 percent and 98 percent as effective as PCR. With viral transport media samples, the sensitivity and specificity of Alere i RSV was 98.6 percent and 97.8 percent when compared to PCR.