骨转换生化标志物的实验室间差异。

Interlaboratory variation of biochemical markers of bone turnover.

作者信息

Seibel M J, Lang M, Geilenkeuser W J

机构信息

Department of Medicine, University of Heidelberg, Bergheimerstrasse 58, D-69115 Heidelberg, Germany.

出版信息

Clin Chem. 2001 Aug;47(8):1443-50.

PMID:11468235

Abstract

BACKGROUND

Biochemical markers of bone metabolism are used to assess skeletal turnover, but the variability of marker assays is still an issue of practical concern. We describe the results of an international proficiency testing program for biochemical bone markers among clinical laboratories.

METHODS

Two serum and two urine pools (normal and increased marker concentrations) were sent on dry ice to 79 laboratories for analysis within 2 weeks of receipt.

RESULTS

Data were submitted by 73 laboratories. The within-method interlaboratory CVs (CV(IL)s) were as follows: serum bone-specific alkaline phosphatase (n = 47 laboratories), 16-48%; serum osteocalcin (n = 31), 16-42%; urinary free deoxypyridinoline (n = 30), 6.4-12%; urinary total deoxypyridinoline and pyridinoline (n = 29), 27-28%; urinary N-terminal cross-linked telopeptide of type I collagen (n = 10), 39%; serum C-terminal cross-linked telopeptide of type I collagen (ICTP; n = 8), 22-27%; urinary hydroxyproline (n = 13), 12%. Analytical results showed both systematic and nonsystematic deviations. In identical samples, results obtained for the same marker by the same method differed up to 7.3-fold. In urine-based assays, correction for urinary creatinine slightly increased CVs.

CONCLUSION

Even with identical assays and methods, results for most biochemical markers of bone turnover differ markedly among laboratories.

摘要

背景

骨代谢生化标志物用于评估骨骼转换，但标志物检测的变异性仍是实际关注的问题。我们描述了临床实验室间骨生化标志物国际能力验证计划的结果。

方法

将两个血清池和两个尿池（标志物浓度正常和升高）用干冰运送至79个实验室，在收到样本后2周内进行分析。

结果

73个实验室提交了数据。方法内实验室间变异系数（CV(IL)s）如下：血清骨特异性碱性磷酸酶（47个实验室），16% - 48%；血清骨钙素（31个实验室），16% - 42%；尿游离脱氧吡啶啉（30个实验室），6.4% - 12%；尿总脱氧吡啶啉和吡啶啉（29个实验室），27% - 28%；尿I型胶原N末端交联肽（10个实验室），39%；血清I型胶原C末端交联肽（ICTP；8个实验室），22% - 27%；尿羟脯氨酸（13个实验室），12%。分析结果显示存在系统偏差和非系统偏差。在相同样本中，同一方法检测同一标志物得到的结果相差高达7.3倍。在基于尿液的检测中，对尿肌酐进行校正后变异系数略有增加。