Anti-HBc-IgM检测试剂盒性能评估

The performance evaluation of the Anti-HBc-IgM kit

目的探讨新技术-磁微粒化学发光法在检测Anti-HBc-IgM方面的优势,评估国产试剂的临床检测可行性。方法对国产乙型肝炎病毒核心抗体IgM检测试剂盒(磁微粒化学发光法)的各项性能指标评估来了解该试剂盒的性能,试剂盒检出限、精密度、交叉干扰、参考值范围等分析性能进行详细评估,并与市售某主流厂家临床对比进行评估及性能对照。结果评估的Anti-HBc-IgM,各项性能指标优异,其中检出限、精密度达到国际产品相同水平;与市售某主流厂家临床对比3100例样本,阴性符合率为99.56%,阳性符合率为99.16%,总符合率为99.52%。结论评估的Anti-HBc-IgM检测试剂盒可以用于临床评估。

Objective This paper discusses the advantages of a new technique,magnetic particle chemiluminescence method,in the detection of Anti- HBc-IgM,so as to evaluate the clinical feasibility of domestic reagents. Methods The objective of this study was to evaluate the performance indexes of the Anti-HBc-IgM kit in magnetic particle chemiluminescence assay.The detection limit,precision,cross interference and reference range of the kit were evaluated in detail,and compared with that of a mainstream manufacturer. Results The performance indexes of this Anti- HBc-IgM kit were excellent.Among them,the detection limit and precision reached the same level of international products.With the result of 3 100 clinical samples,the negative coincidence rate was 99.56%,the positive coincidence rate was 99.16%,and the total coincidence rate was 99.52%,compared with a mainstream manufacturer. Conclusion This Anti-HBc-IgM kit can be used in clinical evaluation.