In Europe the IVD-CE-mark is mandatory for all in vitro medical devices. Since December 2005 manufacturers are required to validate diagnostic kits according to the European Directive 98/79/EC for in vitro diagnostics. Routine diagnostic laboratories are obligated to use IVD-CE-marked products.

Full CE validation certifies that the product is of highest quality and provides significant cost savings by eliminating the need to spend time and money for extensive validation work and quality control.

QIAGEN offers numerous CE-marked products for human diagnostic use: digene HPV Test, QIAamp DSP Kits, EZ1 DSP Kits, PAXgene Blood RNA Kit, artus PCR Kits, and EASYartus PCR Kits. The CE-marked kits provide exact performance specifications, assuring reliable diagnostic sample preparation and sensitive molecular detection.

QIAGEN holds a worldwide PCR license for diagnostics which allows end customers the use of PCR products in accordance with the applicable label licenses attached to such products as ready-to-use diagnostic kits. QIAGEN's licensed products avoid additional costs for our customers. ISO certification

QIAGEN is ISO-certified (EN ISO 9001, EN ISO 13485), which guarantees highest quality for all processes related to manufacturing diagnostic products.

PAXgene Systems provide complete preanalytical solutions from on-site stabilization and storage to rapid and efficient purification of high-quality nucleic acids. The PAXgene Blood RNA System is IVD-CE-marked in accordance with EU Directive 98/79/EC for in vitro diagnostic use.

QIAamp DSP Kits and BioRobot DSP Instruments are validated for purification of viral nucleic acids from human plasma and serum for in vitro diagnostic purposes. The BioRobot EZ1 DSP and the BioRobot MDx DSP Systems are CE-IVD-marked for in vitro diagnostic use.

A large number of QIAGEN’s diagnostic tests are based on modern molecular analytical methods such as real-time PCR or multiplex PCR. Real-time PCR allows quantification and highly sensitive, specific and rapid detection of pathogens as well as allelic discrimination.

• digene HPV test
  The digene HPV Test detects the 13 clinically-relevant high-risk HPV types that can cause abnormal cervical cells and cervical cancer. It is based on the Hybrid Capture technology using specific RNA probes, hybridization, antibody capture and signal amplification to allow rapid, standardized testing of the genetic material of infectious agents.
  
  
• artus PCR Kits
  Ready-to-use artus real-time PCR kits are developed for the detection of viruses, bacteria and parasites. All artus PCR Kits are validated with manual acid purification systems. Accurate quantitation is ensured through quantitation standards provided with the kits. A ready-to-use master mix facilitates handling, saves time, reduces the risk of contamination, and helps to avoid handling mistakes. An internal control allows monitoring the purification process and excludes false negative results.
  
  EASYartus PCR Kits
  EASYartus PCR Kits are a CE-IVD validated combination of EZ1 DSP Virus Kits with artus PCR technology using the BioRobot EZ1 DSP workstation. This new product line includes EBV, HSV-1/2, and VZV for IVD use ensuring automated processing of clinical samples with full IVD compliance.
  
  
• QIAplex Panels
  QIAplex multiplex PCR panels allow sensitive detection of multiple molecular targets in one test. All QIAplex panels share a proprietary, PCR-based multiplex amplification technology enabling high analytical sensitivity and specificity. QIAplex products are optimized for use with QIAGEN’s LiquiChip 200 Workstation. QIAplex Panels and the LiquiChip 200 Workstation are currently for research use only.
  
  
• Kits for HLA typing
  Olerup SSP kits are for low- and high-resolution HLA typing using the SSP method, and SBTexcellerator HLA Kits enable high-resolution HLA sequencing-based typing. Olerup SSP Kits are CE-marked for in-vitro diagnostic use in Europe.