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	Genetic Analysis Systems in the Clinical Mainstream

> > > ProFlu+™ Assay

ProFlu+™ Assay

General Information

Vendor		Prodesse, Inc.
Item		ProFlu+™ Assay
Features		A Multiplex Real Time PCR Assay for Detection of Influenza A (Matrix Gene) Influenza B (Non-Structural Gene) RSV (Polymerase Gene) Easy to Use Includes Internal Control Includes Enzymes Royalty-Free Simple Workflow A Superior Solution Faster and easier than culture -A few hours, not days; Highly automated Cost-Effective versus rapid tests
Approval		US FDA
Product Number		H44VK00 (Detection Kit) H44VK55 (Control Kit)
Sample		Nasopharyngeal Swab Specimens
Sensitivity		Influenza A - 92.6% (90.4% - 94.3%) 95% CI Influenza B - 98.6% (97.5% - 99.2%) 95% CI RSV - 94.9% (93.2% - 96.2%) 95% CI
Instrumentation Needed		Polyester, rayon or nylon tipped nasopharyngeal swabs RNase/DNase-free 1.5 mL polypropylene microcentrifuge tubes Sterile RNase/DNase-free filter or positive displacement micropipettor tips MagNA Pure LC System Disposables (Reagent Tubs, Reaction Tips, Tip Trays, Cartridges) Cepheid PCR reaction tubes, 25μL Parafilm® M or MagNA Pure LC Cartridge Seal – 70oC Freezer Roche MagNA Pure LC System with software version 3.0.11 Cepheid SmartCycler II Real Time Instrument with Dx Software version 1.7b Micropipettors (range between 1-10 μL, 10-200 μL and 100-1000 μL) Mini-centrifuge with adapter for Cepheid Reaction Tubes Cepheid cooling block
Specificity		Influenza A - 100% (97.1% - 100%) 95% CI Influenza B - 97.8% (88.7% - 99.6%) 95% CI RSV - 89.5% (75.9% - 95.8%) 95% CI
Test Method		Molecular Diagnostic Test
Pricing		Inquire

Product Description

The ProFlu+™ Assay is a multiplex Real Time RT-PCR in vitro diagnostic test for the rapid and qualitative detection and discrimination of Influenza A Virus, Influenza B Virus, and Respiratory Syncytial Virus (RSV) nucleic acids isolated and purified from nasopharyngeal (NP) swab specimens obtained from symptomatic patients. This test is intended for use to aid in the differential diagnosis of Influenza A, Influenza B and RSV viral infections in humans and is not intended to detect Influenza C.

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