诊断学理论与实践

诊断学理论与实践 ›› 2020, Vol. 19 ›› Issue (1): 84-87.doi: 10.16150/j.1671-2870.2020.01.017

• 论著 • 上一篇    下一篇

全自动酶联免疫分析仪检测甲型肝炎病毒IgM抗体的性能验证

王峰蕾1, 吴晓燕1(), 王志成2   

  1. 1.上海市青浦中医医院检验科,上海 201799
    2.复旦大学附属华山医院检验科,上海 200040
  • 收稿日期:2019-11-20 出版日期:2020-02-25 发布日期:2020-02-25
  • 通讯作者: 吴晓燕 E-mail:qher@163.com

Performance verification of a full automatic enzyme immunoassay analyzer for the detecting of HAV-IgM antibody

WANG Fenglei1, WU Xiaoyan1(), WANG Zhicheng2   

  1. 1. Department of Laboratory, Qingpu Hospital of Traditional Chinese Medicine, Shanghai 201799, China
    2. Department of Clinical Laboratory, Huashan Hospital Affiliated to Fudan University, Shanghai 200040, China
  • Received:2019-11-20 Online:2020-02-25 Published:2020-02-25
  • Contact: WU Xiaoyan E-mail:qher@163.com

RichHTML

3

PDF (PC)

77

摘要：

目的：验证和评价全自动酶联免疫分析仪测定甲型肝炎病毒（hepatitis A virus,HAV）IgM的性能。方法：本实验参照美国临床和实验室标准化协会（Clinical and Laboratory Standards Institute, CLSI）的 EP15-A2 文件和中国合格评定国家认可委员会（China National Accreditation Service for Conformity Assessment,CNAS）的CNAL-CL39相关文献,对全自动酶联免疫分析仪测定HAV-IgM的精密度、检出限、正确度以及试剂盒的临界值进行验证。结果：全自动酶联免疫分析仪检测HAV-IgM的批内精密度变异系数（coefficient of variation,CV）为7.77%,批间精密度CV为11.17%,阳性及阴性结果符合率均为100%,检出限为1.0 NCU/mL,符合实验室的要求,与厂家的声明（2.0 NCU/mL）相接近。在临界值验证实验中,检测的样本吸光度值的均值（$\bar{x}$）+3个标准差（SD）=0.032,小于试剂盒提供的临界值（0.105）。结论：全自动酶联免疫分析仪检测HAV-IgM的精密度、正确度、检出限、诊断临界值结果均符合行业标准要求,可满足临床的需要。

关键词: 甲型肝炎IgM, 全自动酶免分析仪, 性能验证

Abstract:

Objective: To verify and evaluate the performance of a full automatic enzyme immunoassay analyzer (Tecan) for the detecting of hepatitis A virus(HAV)-IgM. Methods: According to the EP5-A2 document of Clinical and Laboratory Standards Institute（CLSI）and related documents of China National Accreditation Service for Conformity Assessment-CL39（CNAL-CL39） in combination with the condition of our laboratory, the precision, detection limit, accuracy and cut off value of the full automatic enzyme immunoassay analyzer Tecan for the detecting of HAV-IgM were eva-luated.Results: The intra-and inter-batch coefficient of variation (CV) of Tecan for detecting HAV-IgM were 7.77% and 11.17%, respectively, and the coincidence rates of both positive and negative results were 100%. The detection limit was 1.0 NCU/mL, which met the requirement of laboratory and was close to the statement of manufacturer (2.0 NCU/mL). In the validation experiment for cut-off value, the light absorption value ($\bar{x}$+3SD)=0.032 was less than the value 0.105 provided by the kit. Conclusions: The precision, accuracy, detection limit and cutoff value of the automatic enzyme immunoassay analyzer Tecan for detecting HAV-IgM meet the requirements of manufacturer's standards and clinical needs.

Key words: Hepatitis A virus (HAV)-IgM, Full automatic enzyme immunoassay analyzer, Performance verification

中图分类号: