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目的探讨Nordtest准则在ELISA法检测中评估测量不确定度的适用性。方法使用FAME24/20全自动酶联反应分析仪,收集某预防医学门诊部血清学实验室2015-03/10的抗HAV-Ig M和抗HEV-Ig M的室内质控数据,以及血清学实验室2014-2015年度参加卫生部临床检验中心的室间质量评价计划所反馈的质评结果,应用Nordtest规则,对实验室ELISA法检测中测量不确定进行评估。结果置信度水平为95%,包含因子k=2时,抗HAV-Ig M扩展不确定度U抗HAV-Ig M=79.44%,抗HEV-Ig M扩展不确定度U抗HEV-Ig M=59.31%。结论所得结果基本反映了实验室运用ELISA法检测抗HAV-Ig M和抗HEV-Ig M 2个项目的检测质量,同时,Nordtest准则利用实验室质控数据进行测量不确定度的评定,也适用于目前疾控中心血清学实验室的实际情况。
Objective To investigate the applicability of Nordtest criteria in assessing the uncertainty of measurement in ELISA. Methods FAME24 / 20 automated enzyme-linked reaction analyzer was used to collect laboratory quality control data of anti-HAV-Ig M and anti-HEV-Ig M from serology laboratory of preventive medicine clinics 2015-03 / 10, as well as serological test Room 2014-2015 to participate in the Ministry of Health Clinical Laboratory Center quality evaluation program feedback evaluation results, the application of the Nordtest rule, the laboratory ELISA test to assess the uncertainty. Results The confidence level was 95%, including the expanded uncertainty of anti-HAV-Ig M at a factor of k = 2 U anti-HAV-Ig M = 79.44%, anti-HEV-Ig M expanded uncertainty U anti-HEV-Ig M = 59.31%. Conclusion The results basically reflect the quality of detection of two projects of anti-HAV-Ig M and anti-HEV-Ig M by ELISA in laboratory. Meanwhile, the standard of Nordtest for the measurement of uncertainty of measurement using laboratory quality control data is also applicable In the current CDC serological laboratory actual situation.