| 乙型肝炎诊断试剂国家质控标准的建立 |
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| 引用本文： | 吴绍沅,苏涛,林京香,陈燕,许秋荣,王玉琴,周诚,李河民.乙型肝炎诊断试剂国家质控标准的建立[J].病毒学报,1991(Z1). |
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| 作者姓名： | 吴绍沅 苏涛 林京香 陈燕 许秋荣 王玉琴 周诚 李河民 |
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| 作者单位： | 中国药品生物制品检定所 北京
(吴绍沅，苏涛，林京香，陈燕，许秋荣，王玉琴，周诚)，中国药品生物制品检定所 北京(李河民) |
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| 摘 要： | 按新的方案建立了用于乙型肝炎诊断试剂的国家质控标准。包括用WHO国际标准品标化建立的我国HBsAg、抗-HBs定量标准品,对试剂的特异性、灵敏度、精密性、线性进行质量控制检定的系列参比品,及经过实验制订的检定标准。经近年来的实际应用,对国产试剂质量的提高起到了推动作用。
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| 关 键 词： | 乙型肝炎 诊断试剂 国家质控标准 |
ESTABLISHMENT OF NATIONAL QUALITY CONTROL REFERENCE PANELS FOR HEPATITIS B DIAGNOSTIC REAGENTS IN CHINA |
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| Wu Shaoyuan Su Tao Lin Jinxiang Chen Yan Xu Qiurong Wang Yuqin Zhou Chen Li Hemin.ESTABLISHMENT OF NATIONAL QUALITY CONTROL REFERENCE PANELS FOR HEPATITIS B DIAGNOSTIC REAGENTS IN CHINA[J].Chinese Journal of Virology,1991(Z1). |
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| Authors: | Wu Shaoyuan Su Tao Lin Jinxiang Chen Yan Xu Qiurong Wang Yuqin Zhou Chen Li Hemin |
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| Abstract: | National quality control reference panels for hepatitis B diagnostic reagents have been established according to a new design,including national HBsAg and anti-HBs standards standardized by WHO international standards; reference panels for specificity, sensitivity, precision and linearity test;and national requirements set up by experiments. These panels have been used in nationwide evaluation of hepatitis B kits and in examination tests for license release. They therefore serve effectively to improve the quality of domestic kits. |
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| Keywords: | Hepatitis B Diagnostic reagents National quality control reference panels |
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