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作 者:张小燕 周齐洋 ZHANG Xiao-yan;ZHOU Qi-yang(Jiangsu Institute of Medical Device Testing,Jiangsu Nanjing 210012)
出 处:《中国医疗器械信息》2021年第7期26-29,共4页China Medical Device Information
摘 要:目的:丙型肝炎病毒(Hepatitis C Virus,HCV)感染已成为全球公认的健康难题,目前并没有很好的疫苗和特效药,尽早检出HCV感染者是实现丙型肝炎早期诊断、阻断传播的重要途径。方法:研究通过免疫Core-NS4B融合重组蛋白,制备抗HCV单克隆抗体,并获得5H5和4E7-HRP最优的抗体配对组合,检测120例血清,同时与HCV-RNA检测做比较。结果:阴性血清均未测出阳性,HCV阳性标测出23例阳性,检出率77%,HCV-RNA测出26例,检出率87%;HCV可疑标本测出15例阳性,HCV-RNA测出17例;单项ALT增高的标本测出2例阳性,HCV-RNA测出1例。结论:研究所获得的抗体能够用于HCV抗原检测,具有巨大的潜力,为建立HCV抗原检测试剂盒奠定了基础,为临床检测提供了实验依据。Hepatitis C virus(HCV)infection has become a globally recognized health problem.At present,there are no good vaccines and specific drugs.The early detection of HCV infection is to achieve early diagnosis of hepatitis C and block transmission Important way.In this study,anti-HCV monoclonal antibodies were prepared by immunizing Core-NS4B fusion recombinant protein,and the optimal antibody pairing combination of 5H5 and 4E7-HRP was obtained.120 sera were tested and compared with HCV-RNA testing.The results showed that none of the negative sera was positive.HCV positive markers were tested positive in 23 cases,with a detection rate of 77%,HCV-RNA was tested in 26 cases,with a detection rate of 87%;HCV suspicious specimens were tested in 15 cases,and HCV-17 cases were detected by RNA;2 cases were positive for specimens with a single ALT increase,and 1 case was detected for HCV-RNA.The results show that the antibodies obtained in this study can be used for HCV antigen detection and have great potential,which lays the foundation for the establishment of HCV antigen detection kits and provides experimental basis for clinical detection.
关 键 词:丙型肝炎病毒 CORE NS4B 单克隆抗体 抗体配对
分 类 号:R197.39[医药卫生—卫生事业管理]
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