HIV and Borrelia PCR Kits from QIAGEN now CE-marked
Kits offer reliable and rapid new tests for routine diagnostics
Venlo, Netherlands -- June 26, 2008 - Two new kits for the detection and quantification of the HI virus-1 RNA and Borrelia-specific DNA from QIAGEN are now IvD-CE-certified and available for in vitro diagnostic use across Europe. The artus HI Virus-1 RG RT-PCR Kit provides a high sensitivity of 67 IU/ml and reliable quantification of HIV-1 specific RNA over a broad linear range from 120 to 108 IU/ml. The test allows exact quantification of the viral load, which is essential to monitor the therapeutic success. HIV damages the body's immune system leading to the onset of acquired immune deficiency syndrome (AIDS), the later stage of infection. If HIV is detected at an early stage, life expectancy and quality can be improved tremendously. QIAGEN's HIV test has been CE-validated for use with viral RNA purified from human plasma and has demonstrated quantitative and qualitative concordance with other commercial test systems.
The artus Borrelia LC PCR Kit* detects and quantifies all human pathogenic Borrelia species from skin biopsies, synovial fluid, CSF and ticks. Borrelia infections, caused by tick bites, have increased worldwide and can trigger severe illnesses such as Lyme disease (borreliosis). Symptoms often occur years later if the infection is not detected at an early stage, resulting in chronic and incurable infection. Early detection and prescription of antibiotics is the only way to prevent development of the disease, which is characterized by rheumatic and neurological disorders. QIAGEN's real-time, PCR-based test allows rapid detection of even small numbers of Borrelia bacteria. Another important advantage is its supplementary protocol for the simple extraction of total DNA from ticks using the company's DNeasy Blood & Tissue Kit. Due to the difficult cultivation of Borrelia, up to now only specialized laboratories were able to diagnose borreliosis.
"With the CE mark for the two new artus PCR kits, we provide further standardized, easy-to-use and reliable systems for clinical diagnostic use, allowing appropriate and immediate treatment to improve patient healthcare, " said Dr. Tobias Ruckes, Associate Marketing Director for Molecular Diagnostics. "The CE certificate for high-risk pathogens such as HIV is only granted to test systems that adhere to very strict quality regulations."
The CE mark certifies that the molecular diagnostic kits meet the high quality standards of the European IVD Directive 98/79/EC. It is granted by the TÜV Rheinland as Notified Body only to molecular detection systems of top quality, and is required for sales related to diagnostic use in the European Union.
About the artus HI Virus -1 RG RT-PCR Kit and artus Borrelia LC PCR Kit:
- Highly sensitive detection of as few as 67 IU/ml for the HIV-1 kit and 1.7 copies/µl for the Borrelia kit
- Specific detection of HIV-1 genotypes A to H
- Accurate quantification of viral load over a very broad range
- Full compliance with EU IVD Directive 98/79/EC
* artus PCR kits are not available in all countries.
For more information, please visit: www.qiagen.com/mdx
Pictures for download: http://www.qiagen.com/ProductImages
QIAGEN NV, headquartered in the Netherlands, 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, and assays make these isolated molecules visible to facilitate such vital activities as biological research and detection of disease. QIAGEN has developed and markets more than 500 products as well as instruments that make their use more efficient and accurate. 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, including the only FDA-approved test for human papillomavirus (HPV), the primary cause of cervical cancer. QIAGEN employs more than 2,600 people in over 30 locations worldwide.
Further information about QIAGEN can be found at http://www.qiagen.com/ .