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学科主题: 临床医学
题名:
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
作者: 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
发表日期: 2010-05-01
DOI: 10.1258/acb.2009.009210
卷: 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
所属项目编号: 2006AA020909
项目资助者: National 863 Plan Projects of China
WOS记录号: WOS:000278696500002
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/55957
Appears in Collections:北京大学第一临床医学院_期刊论文

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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

Recommended Citation:
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.
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