Quidel receives two FDA clearances for MDx tests for use on the QuantStudio Dx instrument

Sept. 19, 2013

Quidel Corporation and Life Technologies Corporation have announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearances for the Quidel Molecular Influenza A+B assay and the Quidel Molecular RSV + hMPV assay, both for use on the QuantStudio Dx Real-Time PCR Instrument by Life Technologies. The QuantStudio Dx is Life Technologies' flagship instrument for the diagnostics market, offering the advanced capabilities in flexible sample batching needed by higher-volume hospital and reference laboratories. The two 510(k) clearances add to the infectious disease menu available on the QuantStudio Dx instrument with assays for the diagnosis of some common respiratory tract infections that often share similar influenza-like symptoms and can be difficult to distinguish based on clinical signs and symptoms alone.

The Quidel Molecular Influenza A+B assay reports the presence or absence of influenza A and/or B virus; it does not differentiate influenza A subtypes. However, it does demonstrate the analytical detection of subtype H7N9, and was also cleared to include the analytical detection of H3N2v.

The Quidel Molecular RSV + hMPV assay detects the presence of respiratory syncytial virus (RSV) and/or human metapneumovirus (hMPV). RSV is a respiratory virus that infects the lungs and breathing passages. hMPV, identified in 2001, accounts for approximately 7.1% of respiratory tract infections. RSV and hMPV generally cause mild respiratory tract infection, but can be severe, especially among young children, the immunocompromised, and the elderly. Learn more about Quidel’s molecular assays for RSV + hMPV.