华支睾吸虫IgG抗体检测试剂用血清国家参考品的初筛  

Establishment of national reference for anti-Clonorchis sinensis IgG serum

作　　者：张瑾[1] 薄淑英[1] 杨英超[1] 张影[1] 王国柱[1] 辛晓芳[1] 

机构地区：[1]中国食品药品检定研究院寄生虫疫苗室,北京100050

出　　处：《国际医学寄生虫病杂志》2014年第4期238-240,245,共4页International JOurnal of Medical Parasitic Diseases

基　　金：国家高技术研究发展计划（863计划）（2011AA02A115）

摘　　要：目的 建立华支睾吸虫IgG抗体检测试剂用血清国家参考品. 方法 2010-2012年,在广州进行华支睾吸虫病患者的粪检筛查,收集虫卵阳性者的血清26份.购买健康献血者血浆15份,每份200 ml.采用国内仅有的正在注册的2个华支睾吸虫IgG抗体检测试剂盒进行筛选和评价,确定参考品的组成,并进行分装精度测定和水分测定.选择3个单位对该参考品进行协作标定,检测血清参考品的阳性参考品符合率、阴性参考品符合率、最低检出量. 结果 华支睾吸虫IgG抗体检测试剂用血清国家参考品包括9份阳性参考品,10份阴性参考品,1份最低检出量参考品和1份精密性参考品.2次分装精度分别为0.6％和0.7％.2次水分检测结果均为2.8％.血清参考品的阳性参考品符合率、阴性参考品符合率均为100％,最低检出量均不高于1∶32. 结论 建立了华支睾吸虫IgG抗体检测试剂用血清国家参考品.Objective To establish a national reference for evaluation of detection reagent of antiClonorchis sinensis IgG.Methods A total of 26 serum samples of clonorchiasis patients confirmed by positive stool examination was collected in Guangzhou during 2010-2012,and 15 plasma samples of healthy blood donors were bought for each 200 ml.Samples were screened and evaluated with two domestic registered diagnostic kits for anti-Clonorchis sinensis.The composition of reference was determined,and sub-package accuracy and water content were detected.Three collaborative units were selected to calibrate and to detect the coincidence of positive reference and negative reference and the detection limit.Results The panel of Clonorchis sinensis IgG serum consisted of 9 positive and 10 negative samples,and one lowest detection sample,and one precision sample.Sub-package accuracy was 0.6% and 0.7%.Water content was 2.8%.The coincidence of both positive reference and negative reference was100%,and the detection limit was no more than 1：32.Conclusion The national reference panel of Anti-Clonorchis sinensis IgG serum was established.

关 键 词：华支睾吸虫 检测试剂 国家参考品 

分 类 号：R532.21[医药卫生—内科学]