The Simplexa Influenza A H1N1 (2009) test by Quest Diagnostics, Madison, NJ, has been CE marked and is available as a test kit for distribution to approximately 35 countries in Europe. "As the influenza A(H1N1) 2009 virus continues to spread across the globe, it is imperative that clinicians have access to reliable tests for quickly and definitively identifying infected patients," said Harald Kessler, MD, Medical University of Graz, Austria. "The Simplexa assay may contribute to a fast and reliable option for generating 2009 H1N1 virus test results in molecular laboratories throughout Europe and many other regions. Fast turnaround time can aid in clinical management of patients and allow hospitals to segregate infected patients from other high-risk individuals."

The Focus Diagnostics Simplexa Influenza A H1N1 test employs real-time reverse transcription polymerase chain reaction (RT-PCR) to qualitatively detect the 2009 H1N1 flu virus in a patient's nasal or nasopharyngeal specimens. The test targets a region of the hemagglutinin gene of the 2009 H1N1 influenza virus specifically to detect the presence of 2009 H1N1 influenza RNA, thereby differentiating it from seasonal human influenza A viruses. The World Health Organization (WHO), which provides guidance for countries managing the pandemic, states that RT-PCR is the "only rapid diagnostic test for which a positive result is accepted as confirmation" of human infection with the 2009 H1N1 pandemic virus.

The Focus Diagnostics Simplexa Influenza A H1N1 (2009) test is an outgrowth of an exclusive global distribution agreement between Focus Diagnostics and 3M, under which Focus will develop molecular diagnostic test kits to be sold under the Simplexa brand name and on the 3M Integrated Cycler. The 3M Integrated Cycler supports real-time polymerase chain reaction (PCR) technology and employs advanced data management software to help laboratories process, store, and transfer data quickly and effectively. It can process up to 96 samples per run, and provides results in 30 to 85 min, depending on the test's parameters. It has a small laboratory footprint – 31 cm (12 in) high and 31 cm long.