FDA Approves Quidel's Flu, RSV Diagnostic Assays

FDA Approves Quidel's Flu, RSV Diagnostic Assays
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.

RELATED: Diagnostic Agents Resource Center

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.