FDA Approves Quidel's Flu, RSV Diagnostic Assays
Quidel Corporation and Life Technologies announced that the FDA has granted clearance to the Quidel Molecular Influenza A+B assay and the Quidel Molecular RSV+hMPV assay for use on the QuantStudio Dx Real-Time PCR Instrument.
The Quidel Molecular Influenza A+B assay reports the presence or absence of influenza A+B virus. It does not differentiate influenza A subtypes but it does detect the subtype H7N9 and H3N2v.
The Quidel Molecualr RSV+hMPV assay reports the presence of respiratory syncytial virus (RSV) and/or human metapneumovirus (hMPV).
The molecular kits feature refrigerated storage instead of freezing, ready-to-use reagents, short time to result, and others. The RSV and hMPV assay can be performed using the same extracted RNA as the Quidel Molecular Influenza A+B assay. The QuantStudio Dx provides a touch screen, reagent and sample tracking, and a laboratory information management systems (LIMS) interface.
The assays were previously cleared by the FDA for use with Life Technologies' Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument and Cepheid's SmartCycler II.
For more information call (800) 874-1517 or visit Quidel.com.