This standard provides diagnostic laboratories and diagnostic test manufacturers updated guidelines for determining reference ranges for quantitative laboratory tests. Contains specific recommendations on procedures that can be used to establish and validate reliable reference ranges for use in clinical laboratory medicine. By following these recommendations, laboratories can provide sufficient and useful reference ranges for clinical interpretation.
The reference subject selection process, the importance of preanalytical and analytical considerations, calculation methods and requirements for estimating valid reference intervals, and issues related to the transfer of reference intervals are discussed. Examples of the proposed estimation and calculation processes are given. Finally, issues related to the presentation and use of reference ranges are discussed, followed by a short section that examines a number of important but complementary reference values that are not eligible for inclusion in this International Standard.
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