WORKSHOP ON MEASUREMENT TRACE ABILITY FOR CLINICAL LABORATORY TESTING AND IN VITRO DIAGNOSTIC (IVD) TEST SYSTEMS.

In early November 2000, representatives of government, the IVD industry, and the medical professions from 15 nations representing four continents gathered at NIST to participate in the "Workshop on Measurement Traceability for Clinical Laboratory Testing and In Vitro Diagnostic Test Systems." Their goal: to develop recommendations regarding the needs for measurement traceability for health status markers to (1) address IVD industry needs for compliance with international standards (e.g., EU IVD Directive) and (2) improve comparability of clinical measurement data to facilitate better decision-making by medical professionals. The workshop was attended by 135 scientific experts and stakeholders from around the globe (25 % were from outside the United States).

Traceability to internationally recognized and accepted standards is an important component in assuring the accuracy and comparability of clinical laboratory measurements. In addition, the global marketplace is presenting new demands for measurement traceability. Recently, an important opportunity has emerged that applies new pressure to the quest for traceability and the demand for reference systems. Prompted by the European Union's In Vitro Diagnostics Directive (IVDD), the European Committee for Standardizations Technical Committee 140 (CEN/TC 140), in vitro diagnostic systems, began drafting a standard on metrological traceability. Full implementation of the IVD Directive is expected by December 2003 and will require that calibration of all IVD assays be traceable to available reference materials or methods of higher metrological order.

At the conclusion of the workshop, there was general agreement on some critical issues. The need for global reference systems composed of reference methods, reference materials, and a mechanism for demonstrating competence and equivalence was of paramount importance. Internationally recognized and accepted reference laboratories should implement these reference systems, using a networked approach. In order to meet the immediate requirements of the IVD Directive, a catalog of the available reference methods and reference materials must be communicated to the IVD manufacturers. There was concurrence, that when properly implemented, traceability is a value-added exercise that will improve patient care, testing accuracy, reliability and availability, market access, and, in the long run, reduce costs. However, it was emphasized that efforts undertaken must be designed to minimize redundancy and barriers, encourage new technologies, and facilitate global collaborations.