Title The Asian project for collaborative derivation of reference intervals: (1) strategy and major results of standardized analytes
Authors Ichihara, Kiyoshi
Ceriotti, Ferruccio
Tran Huu Tam
Sueyoshi, Shigeo
Poon, Priscilla M. K.
Mee Ling Thong
Higashiuesato, Yasushi
Wang, Xuejing
Kataoka, Hiromi
Matsubara, Akemi
Shiesh, Shu-Chu
Muliaty, Dewi
Kim, Jeong-Ho
Watanabe, Masakazu
Lam, Christopher W. K.
Siekmann, Lothar
Lopez, Joseph B.
Panteghini, Mauro
Affiliation Yamaguchi Univ, Grad Sch Med, Fac Hlth Sci, Dept Clin Lab Sci, Ube, Yamaguchi 7558505, Japan.
Ist Sci San Raffaele, I-20132 Milan, Italy.
Ctr Standardizat & QC Med Labs, Thanh Pho Ho Chi Minh, Vietnam.
Chiba Cardiovasc Ctr, Clin Lab, Ichihara, Chiba, Japan.
Chinese Univ Hong Kong, Dept Chem Pathol, Hong Kong, Hong Kong, Peoples R China.
Natl Heart Inst, Dept Lab & Blood Serv, Kuala Lumpur, Malaysia.
Univ Ryukyus, Grad Sch Med, Clin Lab, Okinawa, Japan.
Peking Univ, Hosp 1, Dept Clin Lab Med, Beijing 100871, Peoples R China.
Kochi Med Sch, Ctr Med Informat Sci, Kochi, Japan.
Hiroshima Univ Hosp, Clin Lab, Hiroshima, Japan.
Natl Cheng Kung Univ, Dept Med Lab Sci & Biotechnol, Tainan 70101, Taiwan.
Prodia Clin Lab, Jakarta, Indonesia.
Yonsei Univ, Coll Med, Dept Lab Med, Seoul, South Korea.
Beckman Coulter Japan Co, Tokyo, Japan.
Macau Univ Sci & Technol, Macau Inst Appl Res Med & Hlth, Taipa, Peoples R China.
Univ Klinikum, Inst Clin Chem & Pharmacol, Bonn, Germany.
MAHSA Univ Coll, Dept Biomed Sci, Kuala Lumpur, Malaysia.
Univ Milan, Ctr Metrol Traceabil Lab Med CIRME, Milan, Italy.
Yamaguchi Univ, Grad Sch Med, Fac Hlth Sci, Dept Clin Lab Sci, Minami Kogushi 1-1-1, Ube, Yamaguchi 7558505, Japan.
Keywords common reference interval
multicenter study
nested ANOVA
regionality
standardization
COMMON REFERENCE INTERVALS
INTERNATIONAL REFERENCE PREPARATION
PLASMA-PROTEINS
CITIES
Issue Date 2013
Publisher clinical chemistry and laboratory medicine
Citation CLINICAL CHEMISTRY AND LABORATORY MEDICINE.2013,51,(7),1429-1442.
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 degrees 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.
URI http://hdl.handle.net/20.500.11897/391421
ISSN 1434-6621
DOI 10.1515/cclm-2012-0421
Indexed SCI(E)
Appears in Collections: 第一医院

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