The Asian project for collaborative derivation of reference intervals: (1) strategy and major results of standardized analytes

Kiyoshi Ichihara, Ferruccio Ceriotti, Tran Huu Tam, Shigeo Sueyoshi, Priscilla M.K. Poon, Mee Ling Thong, Yasushi Higashiuesato, Xuejing Wang, Hiromi Kataoka, Akemi Matsubara, Shu Chu Shiesh, Dewi Muliaty, Jeong Ho Kim, Masakazu Watanabe, Christopher W.K. Lam, Lothar Siekmann, Joseph B. Lopez, Mauro Panteghini

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Abstract

Background: A multicenter study conducted in Southeast Asia to derive reference intervals (RIs) for 72 commonly measured analytes (general chemistry, inflammatory markers, hormones, etc.) featured centralized measurement to clearly detect regionality in test results. The results of 31 standardized analytes are reported, with the remaining analytes presented in the next report. Method: The study included 63 clinical laboratories from South Korea, China, Vietnam, Malaysia, Indonesia, and seven areas in Japan. A total of 3541 healthy individuals aged 20-65 years (Japan 2082, others 1459) were recruited mostly from hospital workers using a well-defined common protocol. All serum specimens were transported to Tokyo at -80 C and collectively measured using reagents from four manufacturers. Three-level nested ANOVA was used to quantitate variation (SD) of test results due to region, sex, and age. A ratio of SD for a given factor over residual SD (representing net between-individual variations) (SDR) exceeding 0.3 was considered significant. Traceability of RIs was ensured by recalibration using value-assigned reference materials. RIs were derived parametrically. Results: SDRs for sex and age were significant for 19 and 16 analytes, respectively. Regional difference was significant for 11 analytes, including high density lipoprotein (HDL)-cholesterol and inflammatory markers. However, when the data were limited to those from Japan, regionality was not observed in any of the analytes. Accordingly, RIs were derived with or without partition by sex and region. Conclusions: RIs applicable to a wide area in Asia were established for the majority of analytes with traceability to reference measuring systems, whereas regional partitioning was required for RIs of the other analytes.

Original languageEnglish
Pages (from-to)1429-1442
Number of pages14
JournalClinical Chemistry and Laboratory Medicine
Volume51
Issue number7
DOIs
Publication statusPublished - 2013 Jul 1

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All Science Journal Classification (ASJC) codes

  • Clinical Biochemistry
  • Biochemistry, medical

Cite this

Ichihara, K., Ceriotti, F., Tam, T. H., Sueyoshi, S., Poon, P. M. K., Thong, M. L., Higashiuesato, Y., Wang, X., Kataoka, H., Matsubara, A., Shiesh, S. C., Muliaty, D., Kim, J. H., Watanabe, M., Lam, C. W. K., Siekmann, L., Lopez, J. B., & Panteghini, M. (2013). The Asian project for collaborative derivation of reference intervals: (1) strategy and major results of standardized analytes. Clinical Chemistry and Laboratory Medicine, 51(7), 1429-1442. https://doi.org/10.1515/cclm-2012-0421