The Quidel Molecular Influenza A+B and RSV + hMPV assays are part of Quidel's expanding line of molecular diagnostics products. Quidel's product line offers PCR reagent kits that are designed to be used with a molecular laboratory's existing thermocycling infrastructure, effectively requiring no additional capital commitment on the part of the customer. These molecular kits provide attractive features that include refrigerated storage instead of freezing, ready-to-use reagents, a short time to result, and other benefits that favorably affect diagnostic test outcomes. Because most Quidel Molecular assays share a common extraction protocol, the RSV and hMPV Assay can be performed using the same extracted RNA as the Quidel Molecular Influenza A+B Assay.
"Every day, we're hard at work developing products like our Quidel Molecular RT-PCR assays that can offer our customers several unique benefits," said Douglas Bryant, president and chief executive officer of Quidel Corporation, who also added, "We are pleased to have our Quidel Molecular assays FDA-cleared to run on Life Technologies' cutting-edge diagnostic instrument and are excited to provide healthcare professionals with easy-to-use, high-performance assays that aid in the diagnosis of human infectious diseases."
Combining multiple system capabilities in a single footprint, Life Technologies' QuantStudio™ Dx provides a touch screen, reagent and sample tracking, and LIMS (Laboratory Information Management Systems) interface specifically designed for ease of use in diagnostic laboratories.
Flexibility is enabled through an optional Test Development mode allowing the use of readily interchangeable thermal cycling blocks that accommodate 96- or 384-well plates and a proprietary qPCR microfluidics card, which can perform 48 tests on eight samples simultaneously without need for liquid-handling robots. The card can also be used to design and implement custom tests. The Test Development mode is for Research Use Only. Not for use in diagnostic procedures.
"Our partnership with Quidel constitutes a key component of our strategy to expand our presence in the diagnostics space," said Ronnie Andrews, president of genetic analysis and medical sciences at Life Technologies. "We will continue to pursue the opportunity to partner to add content to our FDA Cleared systems in key disease areas."
The Quidel Molecular Influenza A+B and RSV + hMPV assays and QuantStudio™ Dx will be sold and distributed by both Quidel and Life Technologies in the United States, as well as in Europe. Both the assays and instrument are CE-IVD marked for diagnostic use in Europe.
The assays were previously 510(k)-cleared by the FDA for use with Life Technologies' Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument and Cepheid's SmartCycler II.
2 Probable person to person transmission of novel avian influenza A (H7N9) virus in Eastern China, 2013: epidemiological investigation.BMJ 2013; 347.
4 Sloots T.P. et al. 2006 EID. 12:1236-66.
5 Ebihara, T. et al. 2004 J Med Virol 70:281-283.
About Quidel Corporation
Quidel Corporation serves to enhance the health and well being of people around the globe through the development of diagnostic solutions that can lead to improved patient outcomes and provide economic benefits to the healthcare system. Marketed under the QuickVue®, D3® Direct Detection and Thyretain® leading brand names, as well as under the new Sofia® and AmpliVue® brands, Quidel's products aid in the detection and diagnosis of many critical diseases and conditions, including, among others, influenza, respiratory syncytial virus, Strep A, herpes, pregnancy, thyroid disease and fecal occult blood. Quidel's research and development engine is also developing a continuum of diagnostic solutions from advanced lateral-flow and direct fluorescent antibody to molecular diagnostic tests to further improve the quality of healthcare in physicians' offices and hospital and reference laboratories.