[1]周 博,范 霞,赵连爽,等.免疫散射比浊法检测IgG的性能验证[J].现代检验医学杂志,2015,30(03):133-135.[doi:10.3969/j.issn.1671-7414.2015.03.040]
　ZHOU Bo,FAN Xia,ZHAO Lian-shuang,et al.Performance Verification of Analyzing IgG by Immune NephelometryAssay[J].Journal of Modern Laboratory Medicine,2015,30(03):133-135.[doi:10.3969/j.issn.1671-7414.2015.03.040]
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免疫散射比浊法检测IgG的性能验证()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第30卷
期数:
2015年03期
页码:
133-135
栏目:
研究简报·实验技术
出版日期:
2015-06-10

文章信息/Info

Title:
Performance Verification of Analyzing IgG by Immune NephelometryAssay
文章编号:
1671-7414(2015)03-133-03
作者:
周 博; 范 霞; 赵连爽; 康 辉
中国医科大学附属第一医院检验科,沈阳 110001
Author(s):
ZHOU Bo; FAN Xia; ZHAO Lian-shuang; KANG Hui
Department of Clinical Laboratory, the First Affiliated Hospital of Chinese Medical Sciences University,Shenyang 110001,China
关键词:
免疫球蛋白G;  性能验证;  散射比浊分析
分类号:
R446.62
DOI:
10.3969/j.issn.1671-7414.2015.03.040
文献标志码:
A
摘要:
目的 对免疫散射比浊法检测IgG的分析性能进行验证,探讨适用于该系统性能验证的合理模式。方法 参照相关文件及标准,对该系统检测IgG的精密度、正确度、分析测量范围(AMR)和参考区间进行验证。结果 低值样本批内精密度为2.24%,总精密度为2.25%; 高值样本批内精密度为2.73%,总精密度为2.68%; 检测不同批号配套校准品的相对偏倚为5.18%; 初始稀释度AMR为2.44～33.5g/L; 参考区间与厂家声明一致。结论 该系统测定IgG的主要分析性能均与厂家声明的性能一致; 厂家提供的参考区间可以接受,验证方案和统计方法简便、可操作性强。
Abstract:
Objective To test and verify the performance ofanalyzing IgG using nephelometry assay,and discuss reasonable model of performance verification of this system.Methods According to related documents and standards,this study verified the precision,accuracy,assay measurement range(AMR)and reference interval.Results The within-run precision in low level was 2.24%,while it was 2.73% in high level.The overall precision in low level was 2.25%,while it was 2.68%.The relative bias between the results of analyzing the calibrator with a different lotfrom that used for calibrating and its concentration printed was 5.18%.The AMR of the original dilution was 2.44～33.5 g/L.The results of reference interval verification identified with what the manufactur declares.Conclusion The major performances of analyzing IgG by this system are identifies with the manufactur declares.The reference interval offered by the manufactur is acceptable.The verification and calculation methods are simple and convenient,with strong operability.

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备注/Memo

备注/Memo:
作者简介:周 博(1984-),男,学士,主管技师,主要研究方向:临床免疫学检验,E-mail:wallezhou@163.com。
通讯作者:康 辉(1965-),E-mail:kanghui65@sina.com。
更新日期/Last Update: 2015-06-10