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The Quidel® Molecular Influenza A+B Assay is a multiplex real-time RT-PCR assay for the qualitative detection and identification of viral nucleic acids extracted from nasal swabs, nasopharyngeal swabs, and nasal aspirate/wash specimens. The assay is intended to aid in the differential diagnosis of influenza A and/or influenza B viral infections in humans. It has been validated on the Applied Biosystems® 7500 series of real-time PCR systems.
• In a head to head clinical study with over 600 patient samples, the Quidel® Molecular Influenza A+B Assay was more sensitive, specific, and less prone to inhibition than the US market-leading FDA cleared molecular test –The Quidel® Molecular assay revealed 3 more positive A results and 5 more positive B results (confirmed by sequencing) –The Quidel® Molecular assay produced no false positive results compared to 4 generated by the competing assay (again confirmed by sequencing) –The competing assay had a 3% inhibition rate, 3 times more inhibition than the Quidel® Molecular assay • The Influenza A+B assay was successfully tested against 50 strains of influenza including Influenza 2009 H1N1 • Tested using common respiratory specimens such as nasal swabs, nasopharyngeal swabs, and nasal aspirates and washes • Validated on the Applied Biosystems® 7500 series of real-time PCR systems
How It Works The Quidel® Molecular Influenza A+B Assay detects viral nucleic acids that have been extracted from a patient sample. A multiplex RT-PCR reaction is carried out under optimized conditions in a single tube generating amplicons for each of the target viruses present in the sample. Virus identification occurs through the use of target specific primers and a fluorescent-labeled probe that hybridize to a conserved region of a viral gene. For influenza A, this region is a 162 bp sequence within the matrix protein gene. For influenza B, it is a 232 bp sequence within the neuraminidase gene.
The Quidel® Molecular Influenza A+B Assay includes rehydation solution, master mix (containing DNA polymerase with RT activity, primers/probes, dNTPs, and stabilizers), and a process control.
Limitations The Quidel® Molecular Influenza A+B Assay has demonstrated analytical reactivity for multiple subtypes of influenza A (including H1N1). However, this assay is not intended to differentiate influenza A subtypes, such as novel Influenza A H1N1. Additional testing is required if subtype differentiation is required.
For Research Use Only. Not intended for any animal or human therapeutic or diagnostic use.
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