Quality assurance

Abstract

The analysis of cell free DNA is increasingly being used for the early detection of biomarkers relevant to obstetric and oncology practice. Guaranteeing the quality of these analyses is critical to retaining the confidence of the public in these tests. This chapter outlines internal and external quality control and assessment procedures open to laboratories to ensure the production of valid test results. As an example clinical test, the chapter considers non-invasive prenatal testing to determine fetal sex using cell free DNA isolated from maternal plasma. External Quality Assessment as a method through which laboratories can compare their results with a set of peers is also discussed.