Developing a Quality System for Quantitative Laboratory-Developed Tests

Users of laboratory-developed assays face many challenges. In addition to designing an assay, collecting specimens for validation, and completing the validation, they must also design and implement a quality system to ensure continued performance of the assay. The situation is even more complex when dealing with a quantitative assay. This article presents some considerations for navigating the world of quantitative laboratory-developed assays and proposes a paradigm for developing a quality system for these assays.