摘要
目的利用定性试验数据特性,设计适合ELISA定性试验的双区法定性质控图,应用于HBsAg定性检测的室内质量监控。方法将实验室HBsAg检测的质控数据,分别绘制双重反应定性质控图和新设计的双区法定性质控图,进行分析比较。结果双重反应方法需制作两个质控图,且易出现假失控虚发警报;双区法可减少此现象的发生。结论对于监控HBsAg定性检测,双区法优于常规的双重反应法。
Objective Through adopting qualitative test data, designed dual,zone legal quality control charts （QCC）, which suit for ELISA qualitative test, and utilized for qualitative detection of HBsAg in the case of indoor quality control. Methods Analyzed and compared double reaction qualitative QCC and dual-zone legal QCC of HBsAg quality control data. Results Double reaction method requires to draw two QCC. And it is easy to emerge false alarms. But dual-zone method can reduce the occurrence of that. Conclusion Dual-zone method is superior to traditional double reaction method in the detection of HBsAg.
关键词
ELISA
定性试验
质控图
ELISA
Qualitative test
Quality control charts （QCC）
