包虫IgG抗体检测试剂用血清国家参考品的研制

Study on New National Reference Panel for Hydatid IgG Antibody Diagnostic Kits

目的建立新的包虫IgG抗体检测试剂用血清国家参考品,以控制该类试剂的质量,促进包虫病诊断试剂的发展。方法从新疆某医院包虫囊肿手术后病理检查确诊的包虫病人中采集13份阳性血清,从北京某血站收集10份健康献血者的血清作为阴性血清,应用点免疫胶体金渗滤法和酶联免疫法分别在3个实验室进行协作标定。结果与结论该套参考品包括了18份样品,其中包括阳性参考品8份,阴性参考品8份,最低检出量参考品1份及精密性参考品1份,阳性符合率、阴性符合率及精密度都符合要求,最低检出量在1∶16左右,为国内外包虫病诊断试剂生产单位提供了开发和筛选高质量产品的参考材料,有利于控制该类诊断试剂的质量,推动试剂质量的提高。

Objective To prepare the new national reference panel for hydatid IgG antibody diagnostic kits. Methods Collect 13 positive serum samples from the patients in Xinjiang Uygur Autonomous Region which had been confirmed by pathology inspection,as well as 10 negative serum samples from healthy blood donors of some blood-bank. Cooperative calibration was performed in 3 different laboratories. Results and Conclusion The panel was made up with 8 positive samples,8 negative samples,1 sensitivity sample and 1 precision sample. Positive coincidence rate,negative coincidence rate and precision are conformed to the requirements. The limit of detection is about 1：16. The reference would provide important guides on quality control of the kind of kits.