MagNA Pure System for DNA Extraction from Whole Blood Clinical Verification of Pre-Analytical Phase of DNA Testing

Directive 98/79/EC guides laboratory medicine in Europe to large and preferable using properly tested and documented in vitro diagnostic medical devices and their accessories. From that point of view the role of bio-analysts working in clinical laboratories more closely associates with completely validated technologies, intra-laboratory verification of commercial methods and products, long-term total quality management, and making standard operation protocols including the pre-analytical phase of testing. A sufficient amount of purified DNA molecules (without any signs of degradation) is a fundamental preanalytical factor influencing molecular biology examination and correct clinical interpretation of analytical results. Conventional time-consuming extraction procedures based mainly on ethanol precipitation of DNA after cell lysis and removal of contaminants by organic solvents have recently been replaced by faster and more automated separation methods. The principle of these approaches is DNA affinity to the silica surface of chromatographic microcolumns (spin or vacuum systems), or paramagnetic DNA-binding microparticles (1–3). The objective of our work was to verify the clinical usefulness of Roche MagNA Pure system for extraction of human genomic DNA from whole blood, and to compare this robotic technology to Qiagen microcolumn-based extraction system, which has routinely been used in our laboratory since 1999. Klin. Biochem. Metab., 13 (34), 2005, No. 1, p. 10–13.