INTRODUCTION

Focus Diagnostics offers the first commercially available assay
that differentiates 2009 H1N1 from seasonal flu.

PRODUCT ADVANTAGES

• Targets a region of the hemagglutinin gene of the 2009 H1N1 Influenza virus.
• Differentiates from the presence of seasonal Human Influenza A virus.
• Identifies patients infected with the pandemic virus with consideration of symptoms, medical background and other factors.

Analytical performance characteristics were comparable to the 2009 H1N1 PCR run at US public health laboratories.

TESTPRINCIPLE AND PROCEDURE

The Focus Diagnostics Simplexa Influenza A H1N1 (2009) assay is intended for use in laboratories with the ability to perform nucleic acid extraction using PCR on the 3M Integrated Cycler as part of the Microfluidic Molecular System for the in vitro qualitative detection and differentiation of seasonal Influenza A and 2009 H1N1 viral RNA in nasopharyngeal swabs (NPS), nasal swabs (NS), and nasopharyngeal aspirates (NPA) from human patients with signs and symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors.

Focus Diagnostics and 3M Health Care introduce the innovative 3M™ Integrated Cycler to run real-time PCR for:

• Quantitative detection
• Qualitative detection
• Mulit-analyte detection

The 3M Integrated Cycler is the stepping stone to putting new technology in your lab:

Small Footprint

• Length: 31cm (12”)
• Width: 21cm (8”)
• Height: 31cm (12”)

Lightweight

• Less than 8 kg (17 lb)

Regular Power Requirements

• 110/220 volt compatible

Fast Ramp Rates

• Heating > 5°C/sec
• Cooling > 4°C/sec

Universal Disc

• Single-use disc with 96-well capacity

Direct Amplification Disc

• Multi-use disc with 8-well capacity

Simple Barcode Scanning

• For easy sample load

Scalable

• From the amplification of preprocessed samples to full integration

Further information on Simplexa™ and 3M™ Integrated Cycler

EVALUATION

Concordance for 2009 H1N1 Influenza

*One sample was detected by CDC assay with Ct >= 38.0 for all three target detectors, whereas Simplexa assay detected Ct 39.0 for FLUA target and no Ct for H1N1 target. Upon retesting of frozen clinical specimen, both assays detected the sample as positive for Influenza A.
**One sample was detected by Simplexa assay with Ct >= 36.0 for both target detectors, whereas CDC assay did not detect Ct value for any target detectors. Upon retesting of frozen clinical specimens, both assays did not detect Influenza A or 2009 H1N1.

Concordance for Seasonal Influenza A
*One sample was detected by Simplexa assay with Ct > 37.0 for FLUA detector, whereas CDC assay did not detect Ct value for any target detector. Upon retesting of frozen clinical specimens, Simplexa assay did not detect Ct value for any target detector, whereas CDC assay detected the influenza A target with Ct >= 36.0. One sample was detected by Simplexa assay with Ct >= 36.0 for both target detectors, whereas CDC assay did not detect Ct value for any target detectors. Upon retesting of frozen clinical specimens, both assays did not detect Influenza A or 2009 H1N1.

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