RSV Plus Human Metapneumovirus Assay Approved

Viral infections are the most frequent causes of morbidity and mortality due to respiratory dysfunction worldwide, especially in children under five years of age. Several studies have reported the association of Human Metapneumovirus (hMPV) and Respiratory Syncytial Virus (RSV) with acute respiratory infection.

The most common clinical symptoms are cough, fever, nasal congestion, and shortness of breath, but may progress to bronchiolitis or pneumonia. RSV and hMPV are also important viral respiratory pathogens in the elderly. In adults greater than 50-years-old, hospitalization rates for RSV and HMPV were similar to those associated with influenza.

The US Food and Drug Administration (FDA, Silver Springs, MD, USA) have approves for clearance to market the Solana respiratory syncytial virus (“RSV”) + human metapneumovirus (“hMPV”) Assay (Quidel, San Diego, CA, USA) for the detection of nucleic acids isolated from nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection to aid in the diagnosis of RSV and/or hMPV infections. The Solana RSV + hMPV Assay is intended for use only with the Solana instrument.

The Solana molecular platform leverages Quidel’s Helicase-Dependent Amplification (HDA) technology, and in the case of Solana RSV + hMPV Assay, a novel Reverse-Transcriptase HDA that is resident in Quidel’s AmpliVue molecular product line to generate a fast and accurate test result. Solana can process up to 12 patient samples in each 45-minute run, thereby providing time-saving workflow advantages to healthcare professionals in moderately complex settings, which is critical during a busy respiratory season when testing volumes are at their highest.

Douglas C. Bryant, BA, president and chief executive officer of Quidel Corporation, said, “We are pleased to introduce an additional innovative, rapid testing solution that addresses the leading cause of viral respiratory infections in both the young and elderly, RSV and hMPV. This economic and focused approach to testing to detect and differentiate these infections replaces expensive syndromic panels or laboratories capable of performing high complexity testing. The Solana RSV + hMPV assay is an easy-to-use, rapid molecular diagnostic test that has superb clinical accuracy. The assay requires no upfront extraction of RNA and generates an accurate result in approximately 45 minutes.”