CE Mark for Respiratory Infections Molecular Diagnostic Test Announced by Quidel

14 Mar 2012
Sonia Nicholas
Managing Editor and Clinical Lead

Product news

Quidel Corporation has announced that it has received a CE Mark for the Quidel MolecularTM RSV + hMPV assay for the detection of respiratory syncytial virus (RSV) and human metapneumovirus (hMPV). The assay distinguishes between RSV and hMPV, two different viruses that can cause respiratory infections with very similar symptoms.

The Quidel Molecular product line offers PCR reagent kits which can be run by molecular diagnostic laboratories using their existing thermocyclers. Advantages of the reagent kits include their simple transport and storage (refrigerated not frozen), convenient workflow, and quick results. The RSV + hMPV assay shares a common extraction protocol with the Quidel Molecular Influenza A+B PCR assay, they can be batched together in the same multi-well panel for customized multiplexing capability.

"We are very proud to receive CE Mark for RSV + hMPV, our newest Quidel Molecular product offering," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "We are pleased with our ability to provide healthcare workers in Europe with a diversified set of molecular testing options while also making efficient use of their existing test infrastructure."

This assay is Quidel's third molecular product offering to receive authorization to market in Europe. Quidel Molecular assays for Influenza A+B and hMPV received CE Marking in August and September of last year, respectively. Quidel Molecular RSV + hMPV is not for sale in the U.S. at this time.

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PCR and Thermal CyclingPolymerase chain reaction (PCR) kits and thermal cyclers are used for the in vitro amplification of DNA permitting subsequent analysis and experimental procedures. Explore a range of high-quality polymerase, primers and nucleotides or simplify your workflow with a PCR mastermix. Find reverse transcription PCR (RT-PCR) and cDNA synthesis kits for RNA products and libraries. Quantitatively measure the amplification of DNA with real-time PCR (qPCR) and droplet digital PCR (ddPCR) kits and systems, and discover automated PCR setup solutions to increase throughput. Alternative DNA amplification methods also include recombinase polymerase amplification (RPA) kits. Find the best PCR kits and thermal cyclers and purification equipment in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.MicrobiologyMicrobiology is the study of microorganisms including protists, prokaryotes, fungi, and, often, viruses. Microorganisms are a useful research tool as genetic vectors and, in immunology, for antibiotic susceptibility testing, cellular biology and genetics. Microorganisms commonly grow readily in incubators with microbial culture media; this can contain chromogenic supplements to differentiate between cell lines. Estimate your culture’s density of microorganisms with colony counters, or screen and select colonies for desirable clones with automated colony pickers. Additionally, equipment is available to monitor environments for the presence of microbes and identify with microbial identification instruments. Find the best microbiology products in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Clinical GeneticsMolecular Genetics covers the analysis of hereditary genetic disease and chromosomal abnormalities. Genetics can be analysed using DNA, RNA, and protein microarrays, PCR, RT PCR and DNA sequencing. Genetic equipment includes genetic workstations, thermal cyclers, cooling blocks and electrophoresis products. Diagnostic kits are used for DNA / RNA extraction and purification.Clinical MicrobiologyMicrobiology is the study of microorganisms including protists, prokaryotes, fungi, and, often, viruses. Microorganisms are a useful research tool as genetic vectors and, in immunology, for antibiotic susceptibility testing, cellular biology and genetics. Microorganisms commonly grow readily in incubators with microbial culture media; this can contain chromogenic supplements to differentiate between cell lines. Estimate your culture’s density of microorganisms with colony counters, or screen and select colonies for desirable clones with automated colony pickers. Additionally, equipment is available to monitor environments for the presence of microbes and identify with microbial identification instruments. Find the best microbiology products in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Respiratory InfectionsRespiratory infections are caused by pathogens such as bacteria, viruses, and fungi, leading to diseases like pneumonia, tuberculosis, and COVID-19. It is important to identify respiratory infections quickly in patients to ensure appropriate treatment and care, and to prevent sepsis. Browse our peer-reviewed product directory to find the best tools for respiratory infection detection, compare products, check reviews, and get pricing directly from manufacturers.