Biological variation estimates obtained from Chinese subjects for 32 biochemical measurands in serum

被引:1
作者
Ma, Liming [1 ]
Zhang, Bin [1 ]
Luo, Limei [1 ]
Shi, Rui [1 ]
Wu, Yonghua [1 ]
Liu, Yunshuang [1 ]
机构
[1] Univ Elect Sci & Technol China, Mianyang Cent Hosp, Sch Med, Dept Clin Lab, Changjia Alley Jingzhong St 12, Mianyang 621000, Sichuan, Peoples R China
关键词
analytical performance specifications; biochemical measurement; biological variation; index of individuality; reference change value; ANALYTICAL PERFORMANCE SPECIFICATIONS; CLINICAL-CHEMISTRY; EUROPEAN FEDERATION; CRITICAL-APPRAISAL; CYSTATIN C; HEALTHY; INDIVIDUALITY; GENERATION; CHECKLIST; ANALYTES;
D O I
10.1515/cclm-2021-0928
中图分类号
R446 [实验室诊断]; R-33 [实验医学、医学实验];
学科分类号
1001 ;
摘要
Objectives The European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) have established a program of work to make available, and to enable delivery of well characterized data describing the biological variation (BV) of clinically important measurands. Guided by the EFLM work the study presented here delivers BV estimates obtained from Chinese subjects for 32 measurands in serum. Methods Samples were drawn from 48 healthy volunteers (26 males, 22 females; age range, 21-45 years) for 5 consecutive weeks at Chinese laboratory. Sera were stored at -80 degrees C before triplicate analysis of all samples on a Cobas 8000 modular analyzer series. Outlier and homogeneity analyses were performed, followed by CV-ANOVA, to determine BV estimates with confidence intervals. Results The within-subject biological variation (CVI) estimates for 30 of the 32 measurands studied, were lower than listed on the EFLM database; the exceptions were alanine aminotransferase (ALT), lipoprotein (a) (LP(a)). Most of the between-subject biological variation (CVG) estimates were lower than the EFLM database entries. Conclusions This study delivers BV data for a Chinese population to supplement the EFLM BV database. Population differences may have an impact on applications of BV Data.
引用
收藏
页码:1648 / 1660
页数:13
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