An international perspective on the derivation of reference intervals
Journal Title: Journal of Analytical Bio-Science - Year 2011, Vol 34, Issue 3
Abstract
International discussions on reference intervals (RI) date back to the late 1980s when the Expert Panel on a Theory of Reference Values in the IFCC elaborated the concept of reference values and methods for the derivation and utilization of RI. Subsequently, a more comprehensible coverage of the topics was made in the USA based on the original theory, which led to the publication of CLSI guidelines on ''Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory'' (C28-A3, the latest edition of 2008). Despite the theoretical formulation and achievement of a global standardization for commonly measured analytes, RIs remain in disagreement among most clinical laboratories. Such a situation reflects the difficulty of individual laboratories in deriving appropriate RIs. The IFCC Committee on Reference Intervals and Decision Limits (C-RIDL) established in 2005 is currently promoting multicenter studies on RIs worldwide. Their key strategy is to adopt centralized assays in each country/region so as to assure the comparability of test results and RIs between each participating laboratory and the central laboratory as well as among central laboratories worldwide. That comparability is achieved by measuring a panel consisting of freshly taken individual sera. The panel-of-sera-based approach allows the multicenter derivation of RIs even for non-standardized analytes, and may thus contribute to the regularization of laboratory tests in general.
Authors and Affiliations
Kiyoshi Ichihara
Keywords
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