Measurement traceability and US IVD manufacturers: the impact of metrology

Abstract

A goal of clinical laboratory science is to produce accurate and comparable patient test results for a specimen independent of analytical methodology. The In Vitro Diagnostics Directive in Europe has provided the impetus for the U.S. in vitro diagnostic (IVD) industry to adapt the concepts of Metrology, the science of measurement, including measurement traceability and measurement uncertainty. The joint committee for traceability in laboratory medicine has provided a valuable database of internationally recognized reference materials and methods and reference laboratories. Much of the responsibility for measurement traceability falls on IVD manufacturers, but all global stakeholders, including the clinical laboratory profession, government Regulatory bodies, metrology institutes, and the providers of EQA/PT surveys, must cooperate to progress toward this goal. The adaptation of the concepts of Metrology to the clinical laboratory is an appropriate and logical development and it will continue in the twenty-first century.