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Application of five frozen human-pooled serum samples assigned by the International Federation of Clinical Chemistry and Laboratory Medicine reference procedure in a traceability investigation of gamma-glutamyltransferase catalytic concentration measurements in China
Xia, Changyu1; Tong, Qing2; Wang, Qingtao2; Tang, Zhuling3; Qi, Lili4; Chi, Shan5; Zhang, Man5; Wang, Xuejing1; Li, Haixia1; Xu, Guobin1
刊名ANNALS OF CLINICAL BIOCHEMISTRY
2010-05-01
DOI10.1258/acb.2009.009210
47页:189-194
收录类别SCI
文章类型Article
WOS标题词Science & Technology
类目[WOS]Medical Laboratory Technology
研究领域[WOS]Medical Laboratory Technology
关键词[WOS]FRESH-FROZEN ; CALIBRATION ; HARMONIZATION ; ENZYMES
英文摘要

Background: The in vitro directive of the European Union requires traceability to the international recommended reference procedures. The application of the reference procedures is necessary in order to evaluate the accuracy of gamma-glutamyltransferase (GGT) assays of routine measurement systems in China.

Methods: Five frozen patient-pooled serum samples were assigned values by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) reference procedure in order to evaluate the traceability of the results of GGT catalytic activity from six homogeneous systems. One of the serum samples was used to calibrate seven non-homogeneous systems.

Results: All of the homogeneous systems, except the Dade system (Dade Bering Inc, IL, USA), achieved traceability within the measurement range. The Roche and Hitachi systems were better than the other systems. After calibration, the variance of the non-homogeneous systems decreased dramatically from between 14.50% and 25.23% to between 1.25% and 3.09% and the bias decreased from between -11.4% and -4.1% to between 0.5% and 3.5%.

Conclusion: Manufacturers in China should ensure that their calibration systems correspond to the IFCC reference procedures. Fresh frozen pooled patient serum assigned by reference laboratories can be used to calibrate non-homogeneous systems in order to achieve traceability.

语种英语
WOS记录号WOS:000278696500002
项目编号2006AA020909
资助机构National 863 Plan Projects of China
引用统计
被引频次:7[WOS]   [WOS记录]     [WOS相关记录]
文献类型期刊论文
条目标识符http://ir.bjmu.edu.cn/handle/400002259/55957
专题北京大学第一临床医学院
作者单位1.Beijing Shijitan Hosp, Clin Lab Dept, Beijing, Peoples R China
2.Biosino Biotechnol & Sci Inc, Beijing, Peoples R China
3.Beijing Chaoyang Hosp, Clin Lab Dept, Beijing, Peoples R China
4.Peking Univ, Clin Lab Dept, Hosp 1, Beijing 100871, Peoples R China
5.Guiyang Med Coll, Clin Lab Dept, Affiliated Hosp, Guizhou, Peoples R China
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GB/T 7714
Xia, Changyu,Tong, Qing,Wang, Qingtao,et al. Application of five frozen human-pooled serum samples assigned by the International Federation of Clinical Chemistry and Laboratory Medicine reference procedure in a traceability investigation of gamma-glutamyltransferase catalytic concentration measurements in China[J]. ANNALS OF CLINICAL BIOCHEMISTRY,2010,47:189-194.
APA Xia, Changyu.,Tong, Qing.,Wang, Qingtao.,Tang, Zhuling.,Qi, Lili.,...&Xu, Guobin.(2010).Application of five frozen human-pooled serum samples assigned by the International Federation of Clinical Chemistry and Laboratory Medicine reference procedure in a traceability investigation of gamma-glutamyltransferase catalytic concentration measurements in China.ANNALS OF CLINICAL BIOCHEMISTRY,47,189-194.
MLA Xia, Changyu,et al."Application of five frozen human-pooled serum samples assigned by the International Federation of Clinical Chemistry and Laboratory Medicine reference procedure in a traceability investigation of gamma-glutamyltransferase catalytic concentration measurements in China".ANNALS OF CLINICAL BIOCHEMISTRY 47(2010):189-194.
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