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目的了解国内丙型肝炎病毒抗体酶标诊断试剂盒的质量。方法应用中国国家丙型肝炎病毒抗体参考品及美国ＢＢＩＡｎｔｉ－ＨＣＶｐａｎｅｌ对Ａｂｂｏｔ等四家国外及六家国内丙型肝炎病毒抗体试剂盒进行了评价。结果１９８份中国国家丙型肝炎病毒抗体参考品中的１００份阳性参考品的检出率，Ａｂｂｏｔ试剂盒为９８％，国产试剂盒为９５％～９７％。对２５份ＢＢＩｐａｎｅｌ中的２３份阳性血清，ｐａｎｅｌ检出率Ａｂｂｏｔ等国外试剂盒为８７％～１００％，国产试剂盒为７０％～９１％。结论国产试剂盒所用丙型肝炎病毒抗原结构区抗原与国外试剂一致，但非结构区抗原较弱。提高国产丙型肝炎病毒抗体试剂盒的质量，应增加高质量的非结构区抗原的应用
Objective To understand the quality of Hepatitis C virus antibody ELISA kit. Methods Four domestic and foreign hepatitis C virus antibody kits Abbot were evaluated using Chinese national hepatitis C virus antibody reference material and the United States BBIAnti-HCVpanel. Results The detection rate of 100 positive reference products in 198 Chinese reference samples of hepatitis C virus antibody was 98% for Abbot kit and 95% -97% for domestic kit. Twenty-three positive sera from 25 BBIpanels showed a panel detection rate of 87% -100% for Abbot and other foreign kits and 70% -91% for domestic kits. Conclusion The hepatitis C virus antigen antigen used in the domestic kit is consistent with foreign reagents, but the non-structural antigen is weaker. Improve the quality of domestic hepatitis C virus antibody kit should increase the application of high-quality non-structural domain antigen