倍比稀释法在医学实验室室间质量评价活动中应用研究

Effect of doubling dilution method in external quality assessment between medical laboratories

目的探讨倍比稀释法在医学免疫学实验室室间质量评价活动中的应用价值。方法以传染病血清学丙型肝炎病毒抗体(anti-HCV)检测为实验项目,将倍比稀释法应用于医学免疫学实验室室间质量评价活动之中,对获得的数据进行汇总、分析。结果基础实验显示不同厂家试剂总阳性判断值和梯度区间存在着显著差异,7家实验室中有6家实验室的检测结果总阳性判断值与基础实验之间无显著性差异,在基础实验梯度区间内。结论倍比稀释法可以评估试剂灵敏度,动态综合评价实验室人员手工操作、试剂和仪器设备使用状况等因素对实验室检测质量与水平的影响,对改进免疫学室间质量评价方式方法具有重要的价值。

Objective To discuss application value of doubling dilution method in external quality assessment（EQA） between medical immunology laboratories. Methods The doubling dilution method was applied to EQA for hepatitis C virus antibody enzyme-linked immunosorbent assay （ELISA） test item in medical immunology laboratories and the test results were analyzed. Results There was significant difference of total positive judgement value between different reagents for basical test results and the gradient interval of different reagents for basical test results were also different. There was no significant difference of total positive judgement value between 6 test results out of 7 laboratories and basical test results. A total of 6 test results out of 7 laboratories were also in the range of basical gradient interval. Conclusion Doubling dilution method can assess different reagents test sensitivity, can comprehensively and dynamically evaluate personnel manual operation ability, reagents and equipments usage and other factors to affect laboratory tests quality and level, so it has important value for improving the way for immunology EQA.