Now Available - PCR Test for H5 and H5N1 Viruses

QIAGEN N.V. a leading provider of solutions for molecular diagnostics have launched globally two novel test kits for the detection of influenza and the avian flu virus (H5N1). These new tests for use in humans and animals provide significant advantages:

- Breakthroughs in sensitivity and speed
- Broad detection of virus strains
- Integrated control mechanism to dramatically reduce false positives
- Most rapid molecular detection of H5 and H5N1 viruses - under 75 minutes
- First and only avian flu PCR (H5N1) test for animals with government approval
- Most widely used test since 2004 for veterinary, export/import and food safety.

The artus™ Influenza/H5 kit combines a broad screening test, with a highly specific assay for the detection of characteristic nucleic acids (RNA) of avian flu (H5N1) virus strains. The highly sensitive test requires only small sample amounts of a patient's sputum, throat and nasal swabs, can detect an infection of influenza or avian flu (H5N1) virus in less than two hours and can be run on the widely available LightCycler instrument.

The second kit added to the portfolio is a specific avian flu (H5N1) molecular detection kit targeting veterinary, import/export control and quarantine needs. This assay was launched in 2004 in China by PG Biotech. QIAGEN announced its agreement to acquire PG Biotech, a leading molecular diagnostics company in China in September of this year. This molecular test is worldwide the first product approved by a governmental authority specifically to detect avian flu (H5N1) in animals. It is believed to be by far the most widely used test kit for this purpose in the world.

QIAGEN has also made available a number of protocols recommended by various government and other public sources to test for avian flu. These protocols have adopted QIAGEN components as the recommended and standard components. Dr. Joachim Schorr, Senior Vice President Global Research & Development added. "Due to the high mutation rate and diversity of the avian flu virus, broad detection of all H5 strains is very important and a significant feature to our new artus™ Influenza/H5 detection kit. Following validation by a renowned research institution, the kit will now be disseminated to leading international institutions.

Product Information
artus™ Influenza/H5 LC RT-PCR Kit
Kit combines a broad screening test (RealArt™ Influenza LC RT-PCR Kit) which detects all influenza A and B viruses with a highly specific detection of characteristic nucleic acids (RNA) of avian flu (H5N1) virus strains. The test comes in a ready to use master mix format and provides a fully integrated solution for avian flu detection when combined with QIAGEN's purification technology for virus, RNA QIAamp®. This combination and an integrated control system dramatically reduce the risk of false positives or negative results thus leading to increases in safety and reliability. During the development of the test the sequences of all H5N1 isolates known to date have been considered. The reliability of the general screening assay (RealArt™ Influenza LC RT-PCR Kit) for all influenza A and B viruses has been validated by several internal and external studies, using among others, samples from the CDC, Atlanta/USA. The artus™ Influenza/H5 LC RT-PCR Kit and RealArt™ Influenza LC RT PCR Kit are based on the real-time PCR technology. Both kits have been developed for the detection of influenza viruses in human samples using the LightCycler instrument. Contrary to the classical detection procedures for influenza viruses which require 7 to 14 days time for results, the specific and highly sensitive QIAGEN detection kit reduces the time to detection of the influenza or avian flu (H5N1) virus to less than two hours. The much shorter analysis time, in combination with highest level s of sensitivity and reliability, allows detection of the influenza virus at a very early stage.

PG Biotech Avian Influenza Virus FQ-PCR Detection Kit
These highly efficient, sensitive and specific real-time PCR based kits can be used to detect Avian Influenza Virus in live poultry through anal and throat swabs, muscle or organ from dead animals, as well as serum or plasma samples. The Generic version of the real-time RT-PCR kit can detect all 15 subtypes (H1-H15) of Avian Influenza Virus A and is suitable for initial screening; the subtype H5, H7 and H9 specific versions can be used on generic tested positive samples subsequently to decide the viral subtypes. The real-time RT-PCR detection methods for Avian Influenza Virus, jointly developed by QIAGEN PG Biotech and Beijing Entry-Exit Inspection and Quarantine, recently approved as the new National Standards by the China State Bureau of Quality and Technical Supervision (CSBTS) and China Association for Standardization (CAS).