[1]黄 迪,尚陈宇,万泽民,等.强生干化学分析仪开放通道检测血清淀粉样蛋白A的性能验证[J].现代检验医学杂志,2018,33(05):137-141.[doi:10.3969/j.issn.1671-7414.2018.05.038]
　HUANG Di,SHANG Chen-yu,WAN Ze-min,et al.Performance Verification of the Measurement of Serum Amyloid A Using the Open Channel of Johnson Dry Chemistry Analyzer[J].Journal of Modern Laboratory Medicine,2018,33(05):137-141.[doi:10.3969/j.issn.1671-7414.2018.05.038]
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强生干化学分析仪开放通道检测血清淀粉样蛋白A的性能验证()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第33卷
期数:
2018年05期
页码:
137-141
栏目:
研究简报·实验技术
出版日期:
2018-11-18

文章信息/Info

Title:
Performance Verification of the Measurement of Serum Amyloid A Using the Open Channel of Johnson Dry Chemistry Analyzer
文章编号:
1671-7414(2018)05-137-05
作者:
黄 迪; 尚陈宇; 万泽民; 柯培锋
广东省中医院检验科,广州 510120
Author(s):
HUANG Di; SHANG Chen-yu; WAN Ze-min; KE Pei-feng
Department of Clinical Laboratory, Guangdong Provincial Hospital of Chinese Medicine,Guangzhou 510120,China
关键词:
干化学;  血清淀粉样蛋白A;  性能验证
分类号:
R446.112
DOI:
10.3969/j.issn.1671-7414.2018.05.038
文献标志码:
A
摘要:
目的 强生干化学分析仪开放通道搭载国产普瑞柏血清淀粉样蛋白A(serum amyloid A,SAA)试剂盒的分析性能验证。方法 根据美国临床和实验室标准化协会(NCCLS)的检测仪器评价标准,并参照卫生部关于分析仪器的性能验证指南,对Vitros 5.1 FS检测SAA的精密度、准确度、线性范围、最大稀释度和生物参考区间进行验证。结果 2个水平SAA批内及总精密度分别为S批内低=0.3,S总低=0.45和S批内高=0.6,S总高=1.01,均小于厂家声明的精密度。比对实验决定系数r2=0.991 2,线性方程Y=0.962 9X+0.204 6,其线性范围可以验证至5.99～92.59 mg/L,最大稀释倍数可验证至10倍。23例健康个体中95.7%的个体SAA检测值处于厂家声明的参考区间之内。结论 Vitros 5.1 FS搭载该SAA试剂盒的分析性能验证通过,该检测系统可以用于临床常规标本检测。
Abstract:
Objective To study the performance verificationof serum amyloid A(SAA)using the open channel of Johnson dry chemistry analyzer.Methods According to CLSI instruments evaluation standards and referring to the NCCL performance verification guides of the analytical instruments,the precision,accuracy,linear range,maximum dilution degree,biological reference range of the SAA detected by Vitros 5.1 FS were verified.Results The intra-batch and total precision experimentswere SiL=0.3,StL=0.45 and SiH=0.6,StH=1.01 respectively,and they were all under the statements of manufacturer.Compared with test r2=0.991 2,linear equation Y=0.962 9X+0.204 6,linearity range were reach 5.99～92.59 mg/L,and the maximum dilution degree was10 times.The SAA results of 95.7% of the 23 healthy individual were within thereference interval announced by the manufacturer.Conclusion Vitros 5.1 FS and the SAA reagent have a good performance,this system can be used in routine tests in laboratory.

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备注/Memo

备注/Memo:
作者简介:黄 迪(1986-),男,硕士,E-mail:125768008@qq.com。
更新日期/Last Update: 2018-09-30