血吸虫病免疫诊断试剂的质量评价  

Quality evaluation for immunological diagnosis kits of schistosomiasis

作　　者：辛晓芳[1] 张谨[1] 薄淑英[1] 王国柱[1] 王国治[1] 

机构地区：[1]中国药品生物制品检定所,北京100050

出　　处：《中国血吸虫病防治杂志》2006年第2期119-121,共3页Chinese Journal of Schistosomiasis Control

基　　金：国家高技术研究发展计划(863计划)(2004AA2Z3461)

摘　　要：目的评价目前我国应用的部分血吸虫病免疫诊断试剂的质量。方法采用血吸虫病诊断试剂IgG抗体免疫血清国家参考品对目前我国应用最广泛的8个血吸虫病免疫诊断试剂进行质量评价。结果8个血吸虫病免疫诊断试剂盒均无国家食品药品监督管理局生产批准文号,其中6个质量较好,精密性一致;另外2个物理检查及外观不合格。结论目前市场上使用的血吸虫病免疫诊断试剂盒质量良莠不齐,应加强规范和管理。Objective To evaluate the quality of immunological diagnosis kits of schistosomiasis. Methods The national reference IgG serum of schistosomiasis was applied for evaluating eight immunological diagnosis kits of schistosomiasis. Results All eight diagnosis kits had no National Production Certificate issued by State Food and Drug Administration. Six kits had good quality with high precision. After the physical examination, two kits did not meet the quality standards. Conclusious The good and bad quality of immunological diagnosis kits of schistosomiasis used in market is intermingled. The quality of these kits should be monitored.

关 键 词：血吸虫病 诊断 试剂盒 质量 

分 类 号：R532.21[医药卫生—内科学]