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Quidel gains CLIA waiver for RSV test

This article was originally published in Clinica

Executive Summary

The US FDA has granted CLIA waiver status for the QuickVue respiratory syncytial virus (RSV) test developed by Quidel. The diagnostic received FDA 510(k) clearance in 2006 (see Clinica No 1228, p 18), and is now more widely available, as the CLIA waiver means it may be offered in physicians' offices and clinics. The QuickVue product detects RSV from nasopharyngeal swab and nasopharyngeal aspirate specimens. It is intended to aid the diagnosis of acute RSV infections in symptomatic paediatric patients, the San Diego, California-based firm said.

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