Quest Diagnostics Incorporated (NYSE: DGX), the world's leading provider of diagnostic testing, information and services, today announced that the Simplexa Influenza A H1N1 (2009) test developed by its Focus Diagnostics business has been CE marked and is now available as a test kit for distribution to approximately 35 countries in Europe. Focus Diagnostics is showcasing the test at MEDICA 2009, November 18 to 21, 2009, at the Dusseldorf Fair Trade Centre, Hall 3, Stand D20, Booth 2 (American Pavilion).
"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, M.D., professor and head of the research unit "Molecular Diagnostics", Medical University of Graz, Austria. "The new 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(TM) Influenza A H1N1 (2009) 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.(1)