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Quidel QuickVue RSV 10 test wins FDA 510(k) Clearance

Quidel, a provider of rapid diagnostic testing solutions, has received 510(k) clearance from the US Food and Drug Administration (FDA) for the sale of its QuickVue RSV 10, a lateral flow immunoassay test for the qualitative detection of acute respiratory syncytial virus (RSV) infections.

Quidel claims that QuickVue RSV 10 detects RSV antigen directly from nasopharyngeal swab and nasopharyngeal aspirate/wash specimens from symptomatic patients under the age of six.

Quidel president and chief executive officer Douglas Bryant said that the signs of an RSV infection are often similar to other respiratory infections, and diagnosis by symptoms alone can be difficult, but their new QuickVue RSV 10 product is a reliable, easy-to-use aid in detecting RSV in children.

“QuickVue RSV 10 offers results in 10 minutes, which can provide a significant time savings to healthcare professionals,” Bryant said.

QuickVue RSV 10 employs the identical test method and sample preparation of the QuickVue Influenza A+B test, allowing for the use of the same nasopharyngeal patient specimen when testing for influenza or an RSV infection.