The Shanghai biobanking DNA quality control program.

Method validation is one of the crucial processes for a professional biobank. However, there are no routine guidelines specially designed for such studies. Therefore, in line with the need for competence in testing and calibration, the International Organization for Standardization (ISO) concept has been introduced to biobanking as a model for Quality Management Systems in this field. Accurate interpretation of the experimental data about the human genome depends on the quality of the genomic DNA. In this study, we focused on the validation of DNA quantitation by spectrophotometry, a basic bio-analytical method in molecular biology. The key factors of precision, accuracy testing, and linearity assessment are presented in assessing the method quality. Internal and external quality controls have been included as required. Our data show that the method of spectrophotometry is qualified for DNA quantitation.