摘要
目的对2013年我国乙型肝炎病毒表面抗原(hepatitis B surface antigen,HBs Ag)诊断试剂盒进行专项抽验调查,以了解目前市场上HBs Ag诊断试剂盒的整体质量水平,加强产品的质量监管。方法依据《中国药典》三部(2010版)HBs Ag诊断试剂(ELISA法)质量标准,应用相应的国家参考品,对全国17个药品生产企业生产的HBs Ag诊断试剂盒(ELISA法)抽验试剂共117批(19个生产文号,涉及全国25个行政区域)进行检测,抽验范围包括生产企业的成品库房、流通领域、基层应用单位(含医院、中心血站等)。结果 117批抽验的样品合格率为100%。从批签发出厂,经流通环节,再到基层应用单位,产品质量基本稳定,未出现质量下降等问题,试剂盒稳定性较好。各国产企业生产的试剂盒间差异较小;adr、adw两个亚型最低检出量之间差异无统计学意义(P>0.05),而ay亚型与adr、adw两个亚型最低检出量差异有统计学意义(P<0.05),ay亚型的最低检出量有待提高。与进口试剂盒相比较,国产试剂的灵敏度尤其是ay亚型的灵敏度低于进口试剂。各试剂间、同一试剂批间精密性差异较小。与2009年抽验相比较,试剂盒质量明显提高。结论我国HBs Ag诊断试剂盒(ELISA法)现行检验标准可行,产品质量状况稳定,HBV ay亚型最低检出量有待提高。
Objective To perform a sampling inspection on diagnostic kit for hepatitis B virus surface antigen（HBs Ag）in China in 2013 so as to understand the quality level and strengthen the quality survey of commercial diagnostic kits.Methods According to requirements in Chinese Pharmacopoeia（Volume Ⅲ, 2010 edition）, a total of 117 batches（19drug approval numbers） of diagnostic kits for HBs Ag manufactured by 17 manufacturers in 25 administrative areas were inspected by using the corresponding national HBs Ag diagnostic reagent panels. The range for inspection included storage,circulation field and grass-root application institutions（such as hospital and blood center）of final products. Results The qualification rate of 117 batches of samples was 100%. The quality was basically stable during the whole courses of lot-release, circulation to application in grass-root institutions, which showed no significant difference in the kits from various manufacturers. The detection levels of subtypes adr and adw showed no significant difference（P〉0. 05）, both of which showed significant difference with that of subtype ay（P〈0. 05）. The sensitivity to subtype ay should be further improved.The sensitivities of domestic kit, especially that to subtype ay, were less than those of imported kits. Little differences were observed between the precisions of various kits and the kits of different batches. The quality of kits were improved significant as compared with those in 2009. Conlusion The current standard for quality control of domestic diagnostic kits（ELISA） for HBs Ag was feasible, and the product quality was stable. However, the sensitivity to HBV subtype ay should be improved.
出处
《中国生物制品学杂志》
CAS
CSCD
2016年第1期45-50,共6页
Chinese Journal of Biologicals
基金
2013年国家药品专项抽验项目(生2013504002001)
关键词
乙型肝炎病毒表面抗原
试剂盒
酶联免疫吸附测定
抽验
Hepatitis B surface antigen（HBs Ag）
Kit
Enzyme linked immunosorbent assay（ELISA）
Sampling inspection
