第3代丙肝试剂国家参考品的研制及初步应用.pdfVIP

2期 (1li口J Blot~icals 1999，V01 l2 No．2 l03 J一 ／， 第3代丙肝试剂国家参考品的研制及初步应用 R l 2 63oZ／- ＼／ 祁自拍 周 诚 扬 振 张庶民 谷金莲 李河民 (中国药品生物制品检定所，北京 10(3050) 摘 要 筛选全国l4个省、市、自治区的25 000多份血样．取其中264份用国产l4种抗I~ICVEIA试剂，国外2 种第3代抗ItCV EIA试剂复检，用RIBA ItCV 3．0和PcR试剂确证。经两轮会同标定，国外两个实验室复核，确定 加份阳性、40份阴性样品组成第3代丙肝试剂国家参考品。40份阴性样品中包括国内外几十种试剂曾经出现过 非特异假阳性反应的阴性样品以及其 S／C值较高的阴性样品。加 份阳性样品中．65％为弱阳性样品，有的样品含 有全谱的抗ItCV抗体，有的样品含有某几种抗tfCV抗体．有的样品以抗ItCV某种蛋白抗体成丹为主，还有的样品 只含有某种特定的抗ItCV蛋白抗体。该参考品已通过专家鉴定并经卫生部批准使用。经改进后达到第3代参考 品标准的国产试剂的临床考核说明．该参考品促进了国产试剂质量的提高，并达到国际先进水平 关键词要! 丛窆 苎～雨晤f讨 ；列 Preparation and Preliminary Application of The Third Generation of Na— tional Reference for Anti—-ItCV Diagnostic Kits Qi Zibai，Zhou Cheng，Yang Zhen et 81(National Institutefor the Control ofPhanna~utical and Biological Products，Beijing 10~050) AIl~lraet More thfltl3 25 0(30 flerum samples were colloeted from 14 provinces．aut0|10瑚舢s r~ion and municipalities direetly under the cenlxal thorities of China．Of the samples．264 were ret~ted bv 14 kinds of anti—HCV EIA kits13lJgldeinChina and 2 kinds ofthe 3rd generatJela ofthe kitsmadei13America，theⅡCOIl— inned byIllHA Hcv 3．0 and PCR rel~elqlS．After2times of eollabortive assi蛐f 吣 by 16 Chinese and 2 American laboratories，40 positive and 40 negadve samples were selected out and used for pI咖 “g the 3rd n锄 肌 of nailonal reference for anti—Hcv diagnostic kits．1k：reference has been evaluated by the expert conmlitee and approved by the／dinistry of Public Health．Clinical trial proved that the reference promoted the improvement of the qualities of nati∞al kits and reached the international leve1． Keywords Hepatitis C Reference 目前国际上的第2代丙型肝炎试剂(抗HCV)已 PCR试剂；Chiton RIBA HCv 3．0 SIA试剂，该试剂说 基本被更先进的第3代试剂所代替 】。为促进国 明书规定，当样品与R