title: Nationwide Multicenter Reference Interval Study for 28 Common Biochemical Analytes in China.
abstract: A nationwide multicenter study was conducted in the China to explore sources of variation of reference values and establish reference intervals for 28 common biochemical analytes, as a part of the International Federation of Clinical Chemistry and Laboratory Medicine, Committee on Reference Intervals and Decision Limits (IFCC/C-RIDL) global study on reference values. A total of 3148 apparently healthy volunteers were recruited in 6 cities covering a wide area in China. Blood samples were tested in 2 central laboratories using Beckman Coulter AU5800 chemistry analyzers. Certified reference materials and value-assigned serum panel were used for standardization of test results. Multiple regression analysis was performed to explore sources of variation. Need for partition of reference intervals was evaluated based on 3-level nested ANOVA. After secondary exclusion using the latent abnormal values exclusion method, reference intervals were derived by a parametric method using the modified Box-Cox formula. Test results of 20 analytes were made traceable to reference measurement procedures. By the ANOVA, significant sex-related and age-related differences were observed in 12 and 12 analytes, respectively. A small regional difference was observed in the results for albumin, glucose, and sodium. Multiple regression analysis revealed BMI-related changes in results of 9 analytes for man and 6 for woman. Reference intervals of 28 analytes were computed with 17 analytes partitioned by sex and/or age. In conclusion, reference intervals of 28 common chemistry analytes applicable to Chinese Han population were established by use of the latest methodology. Reference intervals of 20 analytes traceable to reference measurement procedures can be used as common reference intervals, whereas others can be used as the assay system-specific reference intervals in China.
authors.affiliation: From the Department of Clinical Laboratory, Peking Union Medical College Hospital, Chinese Academic Medical Science and Peking Union Medical College (LX, XC, XQ, JH, PL, LH, SY, LQ), Beijing, China; and Department of Clinical Laboratory Medicine, Institute of Surgery Research, Daping Hospital, the Third Military Medical University (MC), Chongqing, China; Department of Clinical Laboratory, the first Affiliated Hospital, Sun Yat-sen University (ML), Guangzhou, China; Department of Clinical Laboratory, the Second Affiliated Hospital of Zhejiang University School of Medicine (ZT), Hangzhou, China; Department of Clinical Laboratory, the First Affiliated Hospital of Dalian Medical University (SL), Dalian, China; Department of Clinical Laboratory, Xinjiang Medical University (LW), Urumuqi, China; and Faculty of Health Sciences, Yamaguchi University Graduate School of Medicine (KI), Ube, Japan.
authors.forename: Liangyu
authors.initials: L
authors.lastname: Xia
authors.forename: Ming
authors.initials: M
authors.lastname: Chen
authors.forename: Min
authors.initials: M
authors.lastname: Liu
authors.forename: Zhihua
authors.initials: Z
authors.lastname: Tao
authors.forename: Shijun
authors.initials: S
authors.lastname: Li
authors.forename: Liang
authors.initials: L
authors.lastname: Wang
authors.forename: Xinqi
authors.initials: X
authors.lastname: Cheng
authors.forename: Xuzhen
authors.initials: X
authors.lastname: Qin
authors.forename: Jianhua
authors.initials: J
authors.lastname: Han
authors.forename: Pengchang
authors.initials: P
authors.lastname: Li
authors.forename: Li'an
authors.initials: L
authors.lastname: Hou
authors.forename: Songlin
authors.initials: S
authors.lastname: Yu
authors.forename: Kiyoshi
authors.initials: K
authors.lastname: Ichihara
authors.forename: Ling
authors.initials: L
authors.lastname: Qiu
mesh_terms: D000328:Adult; D000704:Analysis of Variance; D044466:Asian People; D002624:Chemistry, Clinical / Q000592:standards*; D002681:China; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D012016:Reference Values; D013048:Specimen Handling; D055815:Young Adult