A new test kit to detect swine flu causing pandemic Influenza A/H1N1 virus strain has been launched by Qiagen.
The new H1N1 screening test enables both the highly sensitive and specific detection of the novel Influenza A/H1N1, the virus that causes swine flu as well as of all other known Influenza A and B virus strains, Qiagen said in a press release.
Qiagen’s new H1N1 screening test artus Influenza/H1 RG/LC RT-PCR Kit can provide accurate results in approximately 40 minutes.
Currently available H1N1 screening tests based on current molecular solutions and most antigen-based can either take up to several hours to produce results. While rapid protein-based H1N1 tests have been found to have a low sensitivity in detecting the virus.
Qiagen’s H1N1 screening test is designed using automated sample and assay technologies such as the thermo cycler Rotor-Gene Q. So the test is also compatible with certain other platforms used in laboratories worldwide, allowing labs to quickly adopt and run it on existing instruments and without the need for additional training.
Qiagen’s H1N1 test kit’s rapid turn around time can result in faster reporting of results which plays a key factor in monitoring and controlling outbreaks.
Artus Influenza/H1 RG/LC RT-PCR Kit has been designed for use by governments and public health institutions as part of the efforts to identify and control outbreaks of pandemic A/H1N1 Influenza, the release said.
Qiagen’s new H1N1 screening kit can also detect infections with other known Influenza A and B strains likely to emerge and disseminate in the population during the upcoming flu season.
“With Qiagen’s new test and our existing solutions to support Tamiflu/Oseltamivir resistance testing, we offer healthcare professionals powerful tools not only to quickly and reliably detect the origin of flu-like symptoms in patients, but also to profile the pathogen and thus to rapidly take the necessary actions to control an outbreak,” said Peer Schatz, CEO of Qiagen.
In the light of the upcoming flu season and the likely emergence and dissemination of other Influenza A and B strains, these capabilities are vital to effectively fight the further dissemination and the effects of the H1N1 pandemic, he added.
Qiagen has already supplied the first lots of new artus Influenza/H1 RG/LC RT-PCR Kit to the government of Saudi Arabia. The government is evaluating the possibility of implementing the screening solution in time to help contain the spread of the virus during the upcoming Mekka pilgrimage.
Qiagen provides a broad portfolio of solutions for the surveillance of the H1N1 pandemic. These include two real time PCR-based screening tests, a test which detects multiple different pathogens in one single run (so called multiplex), and protocols for resistance testing.
Qiagen’s H1N1 portfolio also has sample preparation reagents, enzymes and instrumentation used by labs in testing protocols recommended by international health authorities, including the WHO and the U.S. Centers for Disease Control and Prevention (CDC).
Qiagen entered into supply agreements for pandemic H1N1 swine flu related consumables and instruments with public health authorities in Europe, Asia, Latin America and other regions, during the last few weeks.
Qiagen’s artus Influenza/H1 RG/LC RT-PCR Kit has already been listed for Emergency Use Authorization by the the US Centers for Disease Control and Prevention (CDC).The CDC protocol has now been adopted for the surveillance of swine flu infections in U.S. troops world-wide. A test protocol for evaluating influenza A/H1N1 variations is being widely adopted for H1N1 resistance testing against Tamiflu/oseltamivir.
The new protocol for H1N1 testing is based on Qiagen’s proprietary “Pyrosequencing” assay technology as well as the company’s sample preparation technologies. Qiagen sees significant demand for these solutions as resistance testing on samples that have been found positive using screening tests. This second line testing is increasingly being added to the front line screening efforts.
Artus Influenza/H1 RG/LC RT-PCR Kit is available in the United States for research use only. It has 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 is not intended and should not be used for human diagnostic or any other clinical purposes, Qiagen release clarified.
Swine flu or H1N1 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. H1N1 infection’s 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.
Netherlands-based Qiagen NV, 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. Qiagen provides its H1N1 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 has also developed the first test for the detection of SARS. 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 these viral infections.