[1]龙一飞,林冬玲,陈 富,等.基于EP12-A2文件评价尿蛋白定性检测性能[J].现代检验医学杂志,2015,30(02):117-119,122.[doi:10.3969/j.issn.1671-7414.2015.02.036]
　LONG Yi-fei,LIN Dong-ling,CHEN Fu,et al.Evaluate the Performance of Urine Protein Qualitative Test by EP12-A2 Document[J].Journal of Modern Laboratory Medicine,2015,30(02):117-119,122.[doi:10.3969/j.issn.1671-7414.2015.02.036]
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基于EP12-A2文件评价尿蛋白定性检测性能()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第30卷
期数:
2015年02期
页码:
117-119,122
栏目:
研究简报·实验技术
出版日期:
2015-03-20

文章信息/Info

Title:
Evaluate the Performance of Urine Protein Qualitative Test by EP12-A2 Document
作者:
龙一飞; 林冬玲; 陈 富; 许振杰; 陈中华; 刘建平; 李 松; 李有强; 王丽娜
广东省中医院检验科,广州 510000
Author(s):
LONG Yi-fei; LIN Dong-ling; CHEN Fu; XU Zhen-jie; CHEN Zhong-hua; LIU Jian-ping; LI Song;  LI You-qiang; WANG Li-na
Department of Clinical Laboratory, Guangdong Provincial Hospital of Chinese Medicine,Guangzhou 510000,China
关键词:
尿蛋白定性;  性能评价;  EP12-A2
分类号:
R446.112
DOI:
10.3969/j.issn.1671-7414.2015.02.036
文献标志码:
A
摘要:
目的 评价AX-4030与Cobas U411尿干化学分析仪在尿蛋白定性检测的分析性能,探讨定性试验性能评价方法。方法 参照美国临床实验室标准化协会(CLSI)EP12-A2文件推荐方法,对日本京都AX-4030和罗氏Cobas U411尿干化学分析仪两检测系统尿蛋白定性检测做偏倚和不精密度分析,比较两检测系统的C50, C5～C95区间以及不精密度区间。两系统同时检测310份临床尿标本蛋白,统计分析与评价两者结果的一致程度。结果 尿干化学分析仪AX-4030检测系统检测尿蛋白的C50小于CobasU411系统,AX-4030系统的C5～C95区间比U411系统的窄,AX-4030系统的不精密度曲线较U411系统曲线陡峭; 两套系统检测临床标本尿蛋白结果方法学的比较,一致性百分率为96.8%,阳性一致率为82.7%,阴性一致率为99.6%; 95%CI为94.2%～98.16%,Kappa值为0.88。结论 AX-4030检测系统在尿蛋白C50临界值处的灵敏度及不精密度较Cobas U411系统稍优,二者在临床标本检测中的尿蛋白结果一致性程度极强。EP12-A2推荐的定性试验性能评价方法可行、有效。
Abstract:
Objective To evaluate the analysis capability of urine protein qualitative test between AX-4030 and Cobas U411 urine dry chemistry analyzer,and study on evaluating the performance of qualitative test.Methods According to Clinical and Laboratory Standards Institute(CLSI)EP12-A2 document,analyzed the bias and imprecision of urineprotein qualitative test between the Aution MAX AX-4030 and Roche CobasU411 system.Their C50,C5～C95 intervals and imprecision curves were compared.Theprotein of 310 specimens were simultaneously determined by both Cobas U411 andAX-4030,in order to evaluate their concordance.Results C50 for AX-4030 system was less than that for Cobas U411; C5～C95 interval of AX-4030 system was narrower than CobasU411.The imprecision curve of AX-4030 system was steeper than Cobas U411.The comparison of the two analysis systems showed that the concordance was 96.8%,the positive concordance was 82.7%,and the negative concordance was 99.6%.The 95% credibility interval(CI)was 94.2%～98.16% and the Kappa value was 0.88.ConclusionFor the sensitivity and imprecision of urine protein test in the C50 critical value,the AX-4030 system was better than Cobas U411.The concordance of them in determining clinical specimens was pole-strength.The evaluation recommended by the EP12-A2 document is practical and effective.

参考文献/References:

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备注/Memo

备注/Memo:
作者简介:龙一飞(1986-),男,本科,初级技师,主要从事临床血液、体液学检验工作,Tel:13828490702,E-mail:long001fei@126.com。
更新日期/Last Update: 2015-03-20