Molecular Reverse Transcription Polymerase Chain Reaction Detects H1N1 Influenza

A test for Influenza A (H1N1) is available in the form of a test kit for distribution to approximately 35 countries in Europe.

The test, called Simplexa A, was showcased at MEDICA 2009, from November 18-21, 2009, at the Düsseldorf Fair Trade Center in Germany. The 2009 H1N1 Flu Test was developed by Focus Diagnostics (Cypress, CA, USA), a subsidiary of Quest Diagnostics (Madison, NJ, USA), and is now CE marked for international distribution. The Simplexa molecular reverse transcription polymerase chain reaction (RT-PCR) test runs on the 3M (St. Paul, MN, USA) Integrated Cycler.

The Focus Diagnostics Simplexa Influenza A H1N1 (2009) test is an offshoot of an exclusive global distribution agreement between Focus Diagnostics and 3M under which Focus develops and offers molecular diagnostic test kits, to be sold under the Simplexa brand name, on the 3M integrated cycler. The instrument supports RT-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 minutes, depending on the test's parameters. It has a small laboratory footprint, at approximately 31 cm high and 31 cm long.

The Simplexa kit qualitatively detects 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 A virus specifically to detect the presence of 2009 H1N1 influenza RNA, thereby differentiating it from seasonal human influenza A viruses.

"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 molecular diagnostics unit, 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 U.S. Food and Drug Administration (FDA; Silver Spring, MD, USA) has authorized Focus Diagnostics to market and offer its Simplexa Influenza A H1N1 (2009) test for use on the 3M Integrated Cycler to Clinical Laboratory Improvement Amendments (CLIA) high-complexity laboratories for use during the emergency. The 3M Integrated Cycler is a microfluidic molecular diagnostic testing system and is not FDA cleared or approved. This Simplexa Influenza A H1N1 (2009) test has not been FDA cleared or approved. The test has been authorized by FDA under an Emergency Use Authorization. The declaration of emergency will expire on April 26, 2010, unless it is terminated or revoked sooner, or renewed.

Focus Diagnostics, Inc. is an infectious disease diagnostics company, which provides infectious disease reference-laboratory services to hospitals and laboratories throughout the U.S., and manufactures and distributes diagnostic products worldwide. HerpeSelect type-specific Herpes simplex virus (HSV) serology and West Nile virus DxSelect are Focus Diagnostics products used in laboratories throughout the world.

Related Links:
Focus Diagnostics
Quest Diagnostics
3M
Medical University of Graz