The Asian project for collaborative derivation of reference intervals: (2) results of non-standardized analytes and transference of reference intervals to the participating laboratories on the basis of cross-comparison of test results

Kiyoshi Ichihara, Ferruccio Ceriotti, Mori Kazuo, Yang Yang Huang, Yoshihisa Shimizu, Haruki Suzuki, Masami Kitagawa, Kazuyoshi Yamauchi, Sadao Hayashi, Chia Chun Tsou, Yoshikazu Yamamoto, Shigeo Ishida, Linda Leong, Michitaka Sano, Hwan Sub Lim, Akira Suwabe, Hee Yeon Woo, Keiya Kojima, Yoshio Okubo

Research output: Contribution to journalArticlepeer-review

Abstract

Background: The 2009 Asian multicenter study for derivation of reference intervals (RIs) featured: 1) centralized measurements to exclude reagent-dependent variations; 2) inclusion of non-standardized analytes (hormones, tumor makers, etc.) in the target; and 3) cross-check of test results between the central and local laboratories. Transferability of centrally derived RIs for non-standardized analytes based on the cross-check was examined. Methods: Forty non-standardized analytes were centrally measured in sera from 3541 reference individuals recruited by 63 laboratories. Forty-four laboratories collaborated in the cross-check study by locally measuring aliquots of sera from 9 to 73 volunteers (average 22.2). Linear relationships were obtained by the major-axis regression. Error in converting RIs using the regression line was expressed by the coefficient of variation of slope b [CV(b)]. CV(b)

Original languageEnglish
Pages (from-to)1443-1457
Number of pages15
JournalClinical Chemistry and Laboratory Medicine
Volume51
Issue number7
DOIs
Publication statusPublished - Jul 1 2013

Keywords

  • harmonization
  • immunoassays
  • multicenter study
  • standardization

ASJC Scopus subject areas

  • Clinical Biochemistry
  • Biochemistry, medical

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