Qiagen has launched an influenza A/H1N1 test and several updates to its surveillance solutions related to swine flu. It has been designed for use by governments and public health institutions as part of their efforts to identify and control outbreaks of pandemic A/H1N1 influenza.
The test kit is available in the U.S. for research use only. It has not been cleared or approved by the FDA or any other regulatory agency in the country or under the European IVD directive for human diagnostic or other clinical use.
The first customer to order lots of Qiagen’s artus Influenza/H1 RG/LC RT-PCR Kit is the government of Saudi Arabia. It is evaluating the possibility of implementing the screening solution in time to help contain the spread of the virus during the upcoming Mecca pilgrimage.
Qiagen says that the kit enables both the highly sensitive and specific detection of the influenza A/H1N1 as well as of all other known influenza A and B virus strains. Results for A/H1N1 are produced in approximately 40 minutes. This is unlike many current molecular solutions and most antigen-based H1N1 tests, which can either take up to several hours, as well as rapid protein-based tests, which have been found to have a low sensitivity in detecting the virus, according to Qiagen.
The kit is designed for use with Qiagen’s automated sample and assay technologies such as the thermocycler Rotor-Gene Q. The test is also compatible with certain other platforms used in laboratories worldwide, Qiagen notes.
“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,” remarks Peer Schatz, CEO.
Qiagen’s portfolio of H1N1 surveillance tools include two real-time PCR-based screening tests, a device that detects multiple pathogens in a single run, and protocols for resistance testing. The company’s solutions include individual sample-preparation reagents, enzymes, and instrumentation used in testing protocols recommended by international health authorities including the WHO and the CDC.
During the last few weeks Qiagen reports that it has entered into supply agreements for consumables and instruments with public health authorities in Europe, Asia, Latin America, and other regions.