Solutions for Swine Flu Surveillance

Viral sequence analysis suggests that two of the company’s screening tests identify currently spreading H1N1 subtype

QIAGEN today announced that two of its tests can be used to screen for the swine flu virus which increasingly affects humans in countries around the globe. Data analysis of the viral gene sequences showed that both products already marketed, the artus Influenza LC RT PCR Kit and the Resplex II 2.0 Kit*, can be used to detect whether or not Influenza A virus sequences are present in a sample, including the H1N1 subtype. If the sample proves positive, treatment with widely available medication such as Tamiflu or Relenza can be prescribed, according to the recommendations given by the corresponding drug manufacturers.

 “We have compared the swine fever virus’ sequence with our assays. The primers, which define the starting and end points of a genetic sequence that is amplified to make the target sequence visible, match 100 percent for the artus kit and almost 100 percent for the Resplex kit”, said Dr Thomas Grewing, Senior Director R&D for QIAGEN Hamburg. “We are now working closely with reference institutions to have both assays further re-validated and optimized based on clinical samples”.

 QIAGEN provides several solutions for swine flu screening, testing and research which include:

 1) QIAGEN’s artus Influenza Kit, globally one of the most widely used assays in influenza screening, uses Polymerase Chain Reaction (PCR) and runs on LightCycler, a widely used detection platform.

2) QIAGEN’s Resplex II v 2.0 assay, a multiplex test which is also PCR based, not only differentiates between Influenza Type A and B, but also detects whether a sample contains additional respiratory related viruses.

3) QIAGEN components: In addition to test kits, QIAGEN offers a number of components used for testing of samples including sample preparation reagents, PCR enzymes, and instrumentation. These components are widely used by laboratories to create their own tests (so called homebrew assays). For instance, in the United States, the Centers for Disease Control and Prevention (CDC) has identified a study performed in Norway that utilized an assay which incorporated QIAGEN components (QIAGEN OneStep RT PCR) and ran on the company’s Rotor-Gene Q detection platform (http://www.cdc.gov/eid/content/15/2/155.htm).

 Influenza diagnostics using PCR are considered to be faster and more reliable than other methods such as immunodiagnostics. In its recent guidance to Influenza laboratories issued on April 25, the WHO stated that “Rapid antigen tests designed to detect Influenza A viruses should be able to detect this swine virus but due to the low sensitivity, compared to other lab diagnostic methods, may give false negative results”.

 Guidance to Influenza Laboratories

“Early and reliable screening is a key factor for efficient surveillance and effective response strategies, especially since antiviral influenza treatment is available in large amounts and vaccines are still under development”, says Peer Schatz, CEO of QIAGEN. “Our tests are suited for fast and reliable screening of Influenza A virus types, including the swine flu strain which currently is reported to spread around the world so rapidly. They can therefore help to contain an outbreak which imposes a serious threat to all citizens worldwide. We continue to collaborate with international public health institutions and currently prepare to meet foreseeable increases in demand for our testing solutions.”

 QIAGEN has the worldwide 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 and research of viral infections. QIAGEN is the leading provider of Avian Flu (H5N1) molecular detection tools worldwide and has also developed the first test for the detection of SARS.

 * Both test kits are for research use only. They have not been cleared or approved by authorities including the United States Food and Drug Administration or any other regulatory agency in the United States, or under the European IVD Directive, for human diagnostic or other clinical use, and are not intended and should not be used for human diagnostic or any other clinical purposes. 

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 species barrier and eventually cause disease in humans. The clinical symptoms then 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 escaped from recognition, 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 www.who.int.