电化学发光法检测感染项目的室内质控规则的探讨

Internal principle for quality control in detection of biomarkers for infectious diseases using chemiluminescence assay

目的:发光法定量检测感染标志物是近几年来一种新检测手段,因为其检测方法的特殊性及试剂的局限性一直未有一种很确定的质控规则来有效管理质控数据。本文通过实际操作中使用各种质控方法的心得,来探讨电化学发光法检测感染项目的质控规则。方法:将本实验室几种感染项目在2010年3月至5月份的质控数据绘制成双区定性质控图和Levey-Jennings质控图法,进行分析比较。结果:用Levey-Jennings质控图法可以及时发现系统误差及随机误差可以发现试剂、仪器、操作者存在的问题,效率较高,容易出现假失控;仅用双区法又会使质控数据太散漫而无法判断是哪种误差的存在;结论:将两者结合起来,优于用单一的质控规则。

Objective： During the recent years, chemiluminescence assay for biomarkers of infectious diseases has become a novel method of laboratory investigation. However, an internal principle for quality control （QC） has not been well-shaped and widely used owing to the unique techniques and problematic agents used in this method. We aimed to explore for a principle for quality control in detection of biomarkers for infectious diseases using chemiluminescence assay, based on our experiences with various approaches for quality control in laboratory practicing. Methods： QC data for infectious disease marker between March and May, 2010, were displayed with dual-zone qualitative QC diagram and Levey-Jennings diagram, and compared between each other. Results： Levey-Jennings diagram was effective in identifying systematic error, random error, and problems with reagents, instruments and operators, while were more readily to result in false uncontrolled data. On the other hand, dual-zone diagram was limited by dispersing QC data and not effective in identifying the type of errors. Conclusion： Combined use of the two type of diagram may show advantage over single use of either one.