A real-time RT-PCR assay intended for the in vitro qualitative detection and differentiation of influenza A and 2009 H1N1 influenza viral RNA.

The Focus Diagnostics Simplexa™ Influenza A H1N1 (2009) assay is intended for use on the 3M Integrated Cycler as part of the Microfluidic Molecular System for the in vitro qualitative detection and differentiation of influenza A and 2009 H1N1 influenza 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.

The Focus Diagnostics assay is for use in CLIA high complexity laboratories only.

1. The use of Scorpion^® probes for human in vitro diagnostic purposes is covered by a license to Focus Diagnostics, Inc. from DxS, Ltd.
2. CAL Fluor™ and Quasar™ dyes are trademarks of Biosearch Technologies, Inc. ('BTI'). CAL Fluor and Quasar dye technology is licensed pursuant to an agreement with BTI, and these products are sold exclusively for clinical, diagnostic, or research and development purposes.