Exploration of verification and validation of clinical molecular diagnostics method inspection procedure / 中华检验医学杂志

ABSTRACT

Molecular testing are more and more widely used in clinical practice. The premise of clinical application is the verification or validation of the molecular testing procedure. Establishing a verification and validation model suitable for the testing procedures of clinical molecular testing is helpful for the practitioners of clinical molecular testing to carry out the verification and validation work more conveniently and efficiently. It is also helpful for the standardization of testing and quality control significantly. This article will elaborate on the status of verification and validation of molecular testing projects, the requirements of the ISO15189 accreditation system, the establishment of verification validation models and the prospects in the field.