Quality assurance and quality control in diagnostic molecular biology

The newest forms of clinical diagnostic testing are based upon tools gleaned from molecular biology. Manipulations of RNA and DNA from various tissue sources (e.g., skin, blood, urine, excised tumor) can provide valuable information about an individual's genetic status or the basis or potential for metastasis of a tumor. As of 2002, over 200 laboratories in the United States provide clinical services. Particularly when such information is to be used to provide genetic counseling or determine treatment, care must be taken to ensure accuracy in the generation and reporting of results. This unit outlines the aspects of quality assurance that are important in nucleic acid-based diagnostic testing. More specifically, it describes the three elements of a quality assurance program: the directors qualifications, on-site laboratory inspection, and interlaboratory comparison and proficiency testing. The unit also discusses how to evaluate if a particular genetic test is suitable for clinical testing.