快速荧光灶抑制试验检测狂犬病病毒中和抗体效能评价

Effectiveness evaluation of rapid fluorescent focus inhibition test for rabies virus-neutralizing antibody

目的对人血清中狂犬病病毒中和抗体快速荧光灶抑制试验(RFFIT)进行方法效能评价,为其推广提供技术支撑。方法采用国际标准品、质控参考品和临床血清样品,评价RFFIT方法的检出限、线性、重复性、重现性、特异性和抗干扰能力,并建立质量控制体系。结果 RFFIT方法检出限为0.15 IU/ml;线性曲线斜率为0.999 11,r^(2)=0.980 98;批内重复性和批间重复性的变异系数<5%和<15%;2名不同人员检测结果差异无统计学意义(t=0.348,P=0.731),定性一致率高达100%;71份阳性样品和5份阴性样品定性检测结果的符合率均为100%;8份乳糜血去除乳糜前后的检测结果差异无统计学意义(t=0.022,P=0.983);室间质控和室内质控的变异系数均不超过30%。结论本室建立的RFFIT方法检测效能良好,适用于推广应用。

Objective To evaluate the efficacy of rapid fluorescent focus inhibition test(RFFIT)for rabies virus-neutralizing antibody in human serum,so as to provide technical support for the method promotion.Methods International standard,quality control reference material and clinical serum samples were used to evaluate the performance parameters of the RFFIT method in terms of detection limit,linearity,repeatability,reproducibility,specificity and anti-interference ability,and a quality control system was established.Results The detection limit of RFFIT method was 0.15 IU/ml.The slope of the linear curve was 0.99911(r^(2)=0.98098).Coefficient of variation of in-batch and inter-batch repeatability was<5%and<15%.There was no statistical significance on the difference in the overall results of operation repeatability among two personnel(t=0.348,P=0.731).And the consistency rate of their qualitative results was 100%.The coincidence rate of qualitative results of 71 positive samples and 5 negative samples was 100%.There was no statistical significance on the difference between 8 samples before and after removal of chylous(t=0.022,P=0.983).The variation coefficient of internal and external quality control was less than 30%.Conclusion RFFIT established in our laboratory has good detection efficiency and is suitable for popularization.