Physiological reference values: a shared business? Report of the second European symposium on clinical laboratory and in vitro diagnostics industry

Abstract

The Catalan Association of Clinical Laboratory Sciences, with the support of its corporative members, organized the second European symposium devoted to physiological reference values, in Barcelona. The objectives were: (i) to discuss ways to develop a common strategy among clinical laboratories and the in vitro diagnostic (IVD) industry for the generation of physiological reference values related to biological quantities of medical interest; and (ii) to establish consensus between both groups regarding the interpretation of the requirements related to physiological reference values contained in the European (EU) Directive 98/79-EC and in the EN-ISO 15189:2003 standard. The symposium was divided into four parts in which different aspects of the reference values were discussed: legal and normative aspects, alternatives to the production of own reference values, methodology, and diffusion and teaching. The main conclusions were the need to clarify the requirements described by the EU Directive 98/79-EC and EN-ISO 15189:2003 regarding reference values, and the need for cooperation between industry, clinical laboratories, and health authorities to achieve common reference intervals, including multicentric reference intervals.