[1]刘立民,李 钰,蒙雨明,等.化学发光微粒免疫分析技术检测输血四项的性能评估[J].现代检验医学杂志,2015,30(02):107-110.[doi:10.3969/j.issn.1671-7414.2015.02.033]
　LIU Li-min,LI Yu,MENG Yu-ming,et al.Performance Verification of Chemiluminesent Micropaticle Immunoassay for the Four Blood Index[J].Journal of Modern Laboratory Medicine,2015,30(02):107-110.[doi:10.3969/j.issn.1671-7414.2015.02.033]
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化学发光微粒免疫分析技术检测输血四项的性能评估()
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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:
107-110
栏目:
研究简报·实验技术
出版日期:
2015-03-20

文章信息/Info

Title:
Performance Verification of Chemiluminesent Micropaticle Immunoassay for the Four Blood Index
作者:
刘立民; 李 钰; 蒙雨明; 戴盛明
广西医科大学第四附属医院检验科,广西柳州 545005
Author(s):
LIU Li-min; LI Yu; MENG Yu-ming; DAI Sheng-ming
Department of Clinical Laboratory, the Fourth Affiliated Hospital of Guangxi Medical University,Guangxi Liuzhou 540005,China
关键词:
化学发光;  性能验证;  方法学比对
分类号:
R392.11
DOI:
10.3969/j.issn.1671-7414.2015.02.033
文献标志码:
A
摘要:
目的 验证和评价雅培ARCHITECT-i2000SR化学发光分析仪检测乙肝表面抗原(HBsAg)、抗人类免疫缺陷病毒(HIV)、抗梅毒螺旋体(TP)、抗丙型肝炎病毒(HCV)抗体的性能。方法 对ARCHITECT-i2000SR的精密度、污染携带、参考区间、分析测量范围进行验证; 化学发光微粒免疫分析(CMIA)和ELISA法检测相同标本,进行方法学比对。结果 HBsAg,HIV,TP,HCV抗体的精密度、携带污染和HBsAg参考区间均符合ARCHITECT-i2000SR的性能标准; HBsAg线性回归:Y=1.102X-6.678 6(r=0.995 5,P<0.05),HBsAg线性范围为:1.08～208.6IU/ml; 两种方法检测输血前四项结果的一致性为优。结论 ARCHITECT-i2000SR检测输血前四项的主要性能验证结果与厂家声明的范围基本一致,可用于临床样本的检测。
Abstract:
Objective To evaluate the analytical performance of ARCHITECT-i2000SR chemiluminescence analyzer in detection of HBsAg,HIV-antibody,TP-antibody and HCV-antibody.Methods Validated the precision,carryover,ference interval of alpha-fetoprotein and linearity performance of ARCHITECT-i2000SR.The same specimens were tested by both CMIA and ELISA,and the results were compared and analyzed.Results The precision,carryover and ference interval of alpha-fetoprotein ofHBsAg,HIV-antibody,TP-antibody and HCV-antibody were within the range provided by the manufacturer for ARCHITECT-i2000SR.The theoretical and measured values of HBsAg were:Y=1.102X-6.678 6(r=0.995 5,P<0.05),the range of linearity 1.08～208.6.The sesult was very good for the four blood index by both methods.Conclusion The basic performances of ARCHITECT-i2000SR were consistent with the data provided by the manufacturer,so it canbe used to inspect the clinical samples and the sasults were credible.

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备注/Memo

备注/Memo:
作者简介:刘立民(1984-),男,医学硕士,研究方向:临床免疫诊断,E-mail:jiuxianzi@sina.com。 通讯作者:戴盛明,E-mail: daishm@sina.com。
更新日期/Last Update: 2015-03-20