[1]熊武芳,杨 娜,肖光军,等.同一厂家两种胱抑素C检测试剂盒的性能验证及其 检测结果的一致性[J].医学信息,2018,31(15):55-58.[doi:10.3969/j.issn.1006-1959.2018.15.018]
　XIONG Wu-fang,YANG Na,XIAO Guang-jun,et al.Performance Verification of Two Cystatin C Test Kits and Consistency of Test Results from the Same Manufacturer[J].Journal of Medical Information,2018,31(15):55-58.[doi:10.3969/j.issn.1006-1959.2018.15.018]
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同一厂家两种胱抑素C检测试剂盒的性能验证及其 检测结果的一致性()
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医学信息[ISSN:1006-1959/CN:61-1278/R]

卷:
31卷
期数:
2018年15期
页码:
55-58
栏目:
论著
出版日期:
2018-08-01

文章信息/Info

Title:
Performance Verification of Two Cystatin C Test Kits and Consistency of Test Results from the Same Manufacturer
文章编号:
1006-1959（2018）15-0055-04
作者:
熊武芳; 杨 娜; 肖光军; 刘艳婷; 曹 丹; 李祥坤
遂宁市中心医院检验科，四川 遂宁 629000
Author(s):
XIONG Wu-fang; YANG Na; XIAO Guang-jun; LIU Yan-ting; CAO Dan; LI Xiang-kun
Department of Clinical Laboratory,Suining Central Hospital,Suining 629000,Sichuan,China
关键词:
胱抑素C; 性能验证; 一致性
Keywords:
Key words：Cystatin C; Performance verification; Consistency
分类号:
R446.6
DOI:
10.3969/j.issn.1006-1959.2018.15.018
文献标志码:
A
摘要:
目的 对同一厂家生产的胶体金增强免疫法（标为A）和胶乳免疫比浊法（标为B）胱抑素C测定试剂盒在日立7600全自动分析仪上的分析性能进行验证，并通过方法比对评估两试剂盒检测结果的一致性。方法 参照我国卫生行业标准WS/T420-2013对两试剂盒的精密度、正确度及线性范围进行验证，其结果与厂家声称的性能指标进行比较；并参照EP9-A2文件对两试剂盒进行方法比对，评估其检测结果的一致性。结果 两试剂盒的批内不精密度均≤3.15%，总不精密度均≤4.81%；5份室间质评样本的检测结果与靶值的偏倚≤10.07%；线性范围内其斜率（b）均在0.97~1.03范围内，截距（a）接近于0，相关系数R2均＞0.995，回收率均在理论值±10%的范围内；两试剂盒的以上性能指标均满足YY/T1230-2014行业标准及试剂厂家声明的性能和质量指标的要求。两试剂盒方法比对结果显示，回归方程为Y=1.03X+0.0181，相关系数R2为0.9956，不同医学决定水平处的预期偏倚均小于我国室间质评要求的1/5。结论 某公司生产的两种Cys-C检测试剂盒的分析性能均满意，且两方法间检测结果一致，均能满足临床实验室的要求。
Abstract:
Abstract：Objective To verify the analytical performance of colloidal gold enhanced immunoassay(marked as A)and latex immunoturbidimetric assay(marked as B)cystatin C kit produced by the same manufacturer on Hitachi 7600 automatic analyzer. The consistency of the test results of the two kits was evaluated by comparing the methods.Methods The precision,accuracy and linear range of the two kits were verified by referring to the health industry standard WS/T420-2013 of China, and the results were compared with the performance indexes claimed by the manufacturers,and the two kits were compared with the EP9-A2 documents. Evaluate the consistency of the test results.Results The intraspecific inaccuracies of the two kits were≤3.15%,the total inaccuracies were≤4.81%.The bias between the measured results and the target values of 5 samples was≤10.07%.In the linear range,the slope(b) is in the range of 0.97~1.03, the intercept(a)is close to 0,the correlation coefficient R2 is>0.995,and the recoveries are within the range of theoretical value ±10%.The above performance indexes of both kits meet the requirements of YY/T1230-2014 industry standards and the performance and quality indicators declared by reagent manufacturers.Two kits method comparison result showed that the regression equation was Y=1.03X+0.0181 and the correlation coefficient R2 was 0.9956.The expected bias of different medical decision levels was less than 1/5 of the requirement of our country.Conclusion The analytical performance of the two Cys-C test kits produced by a certain company is satisfactory,and the results of the two methods are consistent,which can meet the requirements of clinical laboratory.

参考文献/References:

[1]中国人民共和国国家卫生和计划生育委员会.临床实验室对商品定量试剂盒分析性能的验证（WS/T420-2013）[S].2013.
[2]National Committee for Clinical Labomtory Standards.EP9-A2 method comparison and bais estimation using patient samples[S].Wayne,PA.USA:NCCLS,2002.
[3]国家食品药品监督管理局.胱抑素C测定试剂（盒）（YY/T1230-2014）[S].2014.
[4]张秀明.浅析定量检验程序分析性能验证实验方案设计[J].中华检验医学杂志,2015(6):428-430.
[5]罗立梅,张彬,陈刚.化学发光微粒子免疫分析法检测性激素6项的性能验证[J].国际检验医学杂志,2017,38(9):1214-1216,1219.
[6]刘海燕,李伟娜,肖波,等.胱抑素C临床检验及在肾脏疾病应用中的研究进展[J].河北医药,2015(21):3311-3315.
[7]周恩武,李明,刘跃平,等.血清胱抑素C测定的临床意义及方法学研究进展[J].现代中西医结合杂志,2014(12):1367-1368.
[8]张小燕,杨宇.胱抑素C的临床应用及检测标准化进展[J].标记免疫分析与临床,2017,24(6):717-720.

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更新日期/Last Update: 2018-08-01