Quality assurance and standardization in view of non-invasive prenatal testing (NIPT)

Abstract

Abstract:The development and utilization of non-invasive prenatal tests have provided new and exciting challenges for quality assurance. Quality managers, scientists and technicians have been faced with the question of appropriate validation and quality controls for these innovative tests. Guidelines on quality assurance and quality control are still lacking and the need is growing inexorably. To integrate non-invasive prenatal tests into existing guidelines, attention must be paid to ISO standard 15189 which describes the requirements for medical laboratories and therefore diagnostic molecular genetics laboratories. Performing the test in an accredited molecular genetics laboratory according to ISO 15189 ensures the adherence to, and compliance with, all important principles. In this article, an overview of quality requirements applied to non-invasive prenatal testing is given from a quality manager's point of view. Keywords

The role of cell-free nucleic acid diagnostics in clinical chemistry and pathology

“…While the results of a first ring trial scheme have been communicated by the Reference Institute for Bioanalytics (RfB), a notified body for external quality assessment in Germany, such schemes need further development. Schenk, who, together with Harasim, was the first to succeed in achieving a medical accreditation for a NIPT procedure in Germany by the DAkkS (the German accreditation body), provides a comprehensive summary on the different aspects of quality management and accreditation in cffDNA [7].…”