Can the QIAsymphony DSP Virus/Pathogen system be used for diagnostic or prognostic procedures?
Yes. The QIAsymphony DSP Virus/Pathogen Kits are designated “For In Vitro Diagnostic Use”. It is the user’s responsibility to validate system performance for any procedures used in their laboratory that are not covered by the QIAGEN performance evaluation studies. The system performance has been established in performance evaluation studies purifying viral DNA and RNA from human serum, plasma, or cerebrospinal fluid (CSF), and purifying viral DNA and RNA, as well as bacterial DNA, from respiratory and urogenital samples. To minimize the risk of a negative impact on the diagnostic results, adequate controls for downstream applications should be used. For further validation, the guidelines of the International Conference on Harmonisation of Technical Requirements (ICH) in ICH Q2 R(1) Validation of Analytical Procedures: Text and Methodology are recommended. Any diagnostic results that are generated must be interpreted in conjunction with other clinical or laboratory findings.