INTRODUCTION

A real-time RT-PCR assay intended for the in vitro qualitative detection and differentiation of influenza A, influenza B & RSV viral RNA.

The Focus Diagnostics Simplexa™ Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (NPS) from human patients with signs and symptoms of respiratory tract infection in conjunction with clinical and epidemiological risk factors. This test is intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C.

Simplexa Flu A/B & RSV Positive Control (Article number 57021) may be used as an external control for QC testing, training or proficiency testing.

TESTPRINCIPLE AND PROCEDURE

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

COMMERCIAL PRODUCT