QIAGEN Tests Clinically Verified for the Monitoring of Swine Flu
German Bernhard Nocht Institute and Spanish Reference Laboratory Unequivocally Detect Infections with the H1N1 Strain Using the artus Influenza Test
Venlo, The Netherlands - April 30, 2009 - Analyses performed by the German Bernhard Nocht Institute for Tropical Medicine have proven that the influenza A / H1N1 virus can be unequivocally detected using a screening test developed by QIAGEN (NASDAQ: QGEN; Frankfurt Prime Standard: QIA). The company's artus Influenza LC RT PCR Kit was successfully used to screen a female patient who had come down with the disease in Mexico and is currently being treated at the Eppendorf University Hospital in Hamburg, Germany. The patient is currently one of three confirmed cases of swine flu in Germany. The results are a clinical verification of the reliability of the QIAGEN test demonstrated by the findings of a data analysis published the day before.
QIAGEN's artus kit is considered to be one of the most widely used assays in influenza screening and serves as standard for the detection of influenza A viruses in numerous laboratories around the world. The test was also used by the Instituto de Salud Carlos III, Centro Nacional de Microbiología in Majadahonda (Spain), to screen for Influenza A infections. Yesterday, the institute verified several possible infections with the H1N1 strain that occurred during the last few days. The national reference laboratory advises other institutions in Spain seeking support that the artus influenza Kit provides maximum reliability for the first-line screening for H1N1. Following this recommendation, some Spanish hospitals yesterday began to identify possible infections with H1N1 using the artus kit.
"QIAGEN's artus influenza test can be performed quickly and the results are faultless. This demonstrates the artus test's ability to detect infections with the influenza A virus including the currently circulating Mexican H1N1 viruses," said Dr Stephan Guenther, Head of Virology at the Bernhard Nocht Institute in Hamburg. Screening tests enable quick and reliable verification of potential infections and thus help to contain the spread of the epidemic. Patients that have tested positive for influenza A can then be treated with one of the commonly available pharmaceuticals such as Tamiflu or Relenza, according to the recommendations given by the corresponding drug manufacturers.
The infection with the H1N1 strain of influenza A in sample material obtained from the patient treated in Hamburg was also successfully detected using the company's second available screening test, the ResPlex II v.2.0 Multiplex Assay. "The signals obtained during the amplification of the corresponding viral sequence were unequivocal, which shows that this test is reliable as well," said Dr Thomas Grewing, Senior Director Research & Development at QIAGEN.
Regulatory approval of both products for in-vitro diagnostic applications has not been sought yet by QIAGEN, but applications can be officially submitted on a short-term basis depending on the further proliferation of the disease.
Meanwhile, the U.S. FDA regulatory body has cleared tests developed by the national Centers for Disease Control and Prevention (CDC) that include QIAGEN test components. "The CDC tests use our consumables for the extraction of genetic information from samples. One CDC test also incorporates our enzymes needed for the amplification of viral sequences to make the information visible," continued Grewing.
QIAGEN offers the broadest portfolio of molecular screening solutions for viral infectious diseases. Public health institutions and more than 80 reference laboratories around the globe use the company's molecular tests and testing components for surveillance of and research on viral infections. QIAGEN is the leading provider of Avian Flu (H5N1) molecular detection tools and also developed the first test for the detection of SARS.
About Swine Flu:
Swine flu (swine influenza) is a highly contagious respiratory disease of pigs, caused by one of several swine influenza A viruses. Since pigs can be infected with more than one virus type at a time, genes of several viruses from various sources (including humans) can mix, allowing the swine influenza viruses to cross the species barrier and eventually cause disease in humans. The clinical symptoms in humans are similar to seasonal influenza and other acute upper respiratory tract infections, in some cases leading to severe pneumonia and resulting in death. However, since mild or asymptomatic cases may have gone unrecognized, the true extent of this disease among humans is still unknown. Currently, there is no human vaccine on the market which protects against swine influenza. Antiviral drugs are available in many countries. More information on the swine flu is available on http://www.who.int/.
QIAGEN N.V., a Netherlands holding company, is the leading global provider of sample and assay technologies. Sample technologies are used to isolate and process DNA, RNA and proteins from biological samples such as blood or tissue. Assay technologies are used to make such isolated biomolecules visible. QIAGEN has developed and markets more than 500 sample and assay products as well as automated solutions for such consumables. The company provides its products to molecular diagnostics laboratories, academic researchers, pharmaceutical and biotechnology companies, and applied testing customers for purposes such as forensics, animal or food testing and pharmaceutical process control. QIAGEN's assay technologies include one of the broadest panels of molecular diagnostic tests available worldwide. This panel includes the digene HPV Test, which is regarded as the "gold standard" in testing for high-risk types of human papillomavirus (HPV), the primary cause of cervical cancer. QIAGEN employs more than 3,000 people in over 30 locations worldwide. Further information about QIAGEN can be found at http://www.qiagen.com/.
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