[1]汪靖园,王林川,肖 尧,等.科华ELISA与雅培i2000sr检测系统对4种感染性疾病8项血清标志物检测的性能评价[J].现代检验医学杂志,2018,33(06):125-131.[doi:10.3969/j.issn.1671-7414.2018.06.033]
　WANG Jing-yuan,WANG Lin-chuan,XIAO Yao,et al.Performance Evaluation of Kehua ELISA and Abbott i2000sr in Eight Serum Markers Detection for Four Infectious Diseases[J].Journal of Modern Laboratory Medicine,2018,33(06):125-131.[doi:10.3969/j.issn.1671-7414.2018.06.033]
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科华ELISA与雅培i2000sr检测系统对4种感染性疾病8项血清标志物检测的性能评价()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第33卷
期数:
2018年06期
页码:
125-131
栏目:
研究简报·实验技术
出版日期:
2018-12-24

文章信息/Info

Title:
Performance Evaluation of Kehua ELISA and Abbott i2000sr in Eight Serum Markers Detection for Four Infectious Diseases
文章编号:
1671-7414(2018)06-125-07
作者:
汪靖园1; 王林川1; 肖 尧1; 阮竞雄1; 田旭东1; 闫 芳2
1.西安交通大学第一附属医院检验科,西安 710061; 2.西安市第三医院输血科,西安 710018
Author(s):
WANG Jing-yuan1; WANG Lin-chuan1; XIAO Yao1; RUAN Jing-xiong1; TIAN Xu-dong1; YAN Fang2
1.Department of Clinical Laboratory,the First Affiliated Hospital of Xi'an Jiaotong University,Xi'an 710061,China; 2.Department of Blood Transfusion,Xi'an No.3 Hospital,Xi'an 710018,China
关键词:
科华ELISA;  雅培i2000sr;  血清标志物;  性能评价
分类号:
R446
DOI:
10.3969/j.issn.1671-7414.2018.06.033
文献标志码:
A
摘要:
目的 对科华ELISA和雅培i2000sr检测系统4种感染性疾病8项血清学标志物的性能进行评价和比较。方法 采用美国临床和实验室标准协会(clinical and laboratory standards institute,CLSI)评价方案(evaluation protocols,EP)评价两种检测系统性能。评价内容包括:准确度、检出限、一致性、精密度、线性范围。结果 两种检测系统的准确度均为100%。HBsAg,HBsAb,HBeAg,HBeAb,HBcAb,Anti-HCV,梅毒特异性抗体及(Anti-TP)Anti-HIV的检出限科华分别为0.08IU/ml,10mIU/ml,0.8NCU/ml,4.4NCU/ml,3.2NCU/ml,0.8NCU/ml,20 mIU/ml和0.5 NCU/ml; 雅培分别为0.05 IU/ml,10 mIU/ml,0.23 NCU/ml,1 NCU/ml,1.8 NCU/ml,0.45 NCU/ml,20 mIU/ml和2.88 NCU/ml。一致性验证:两种系统方法学比对Kappa值分布于0.8～0.9,定性项目仪器间比对Kappa值均为1, 定量项目(HBsAg,HBsAb)仪器间比对观察误差<1/2TEa,浓度误差指数绝对值<1。精密度评价:批内变异系数(CV)范围为1.10%～7.01%,室内CV范围为1.90%～10.03%。雅培i2000sr HBsAg,HBsAb线性范围分别为0.73～245IU/ml和4.21～960.89mIU/ml。结论 科华ELISA和雅培i2000sr准确度、检出限、一致性、精密度和线性范围与厂家声明一致并能满足实验室要求。两种系统HBsAg,HBsAb,Anti-TP检出限接近,但HBeAg,HBeAb,HBcAb,Anti-HCV和Anti-HIV检出限二者存在较大差异。
Abstract:
Objective The present study was carried out toevaluate the performance of Kehua ELISA and Abbott i2000sr for eight serum markers detection.Methods The performances,i.e.,accuracy,limit of detection(LOD),consistency,precision and linear range were evaluated according with the CLSI EP documents.Results The accuracy of the two systems were 100%.The LOD of HBsAg,HBsAb,HBeAg,HBeAb,HBcAb,Anti-HCV,Anti-TP and Anti-HIV were 0.08IU/ml,10mIU/ml,0.8NCU/ml,4.4NCU/ml,3.2NCU/ml,0.8NCU/ml,20mIU/ml and 0.5NCU/ml for Kehua,and 0.05IU/ml,10mIU/ml,0.23NCU/ml,1NCU/ml,1.8NCU/ml,0.45NCU/ml,20mIU/ml and 2.88NCU/ml for Abbott,respectively.The consistency test showed that the Kappa value was 0.8 to 0.9 for method comparison and 1 for instruments comparison.Multipleinstruments comparison for HBsAg and HBsAb,the observed error was <1/2TEa anderror index by concentration was <1.The coefficients of variations(CV)ofwithin-run and laboratory precision were 1.10%～7.01% and 1.90～10.03%,respectively.The linear ranges of HBsAg and HBsAb were 0.73～245IU/ml and 4.21～960.89mIU/ml,respectively.Conclusion The performances oftwo systems,such as LOD,consistency,precision and linear range,were consistent with manufacturer's declaration and met the clinical requirements.Kehua was close to i2000sr on the detection ability of HBsAg,HBsAb and Anti-TP, however,obvious difference in the detection ability of HBeAg,HBeAb,HBcAb, Anti-HCV and anti-HIV was observed between two systems.

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备注/Memo

备注/Memo:
基金项目:陕西省自然科学基金资助项目(No.2017JM8121)。
作者简介:汪靖园(1983-),女,硕士,主管技师,主要从事临床检验,研究方向:病原生物学的研究,E-mail:123436110@qq.com。
通讯作者:闫 芳(1973-),女,主管技师,主要从事临床检验,研究方向:临床用血安全,E-mail:173032147@qq.com。
更新日期/Last Update: 2018-11-30