丙型肝炎核心抗原酶联免疫检测试剂的临床应用  

Clinical application of enzyme immunoassay for the detection of hepatitis C virus core antigen

作　　者：刘湘林 谭德明[2] 索凤霞[3] 刘伟[4] 赵秀英[5] 曾立明[2] 欧阳亦[2] 周松辉 杨锡琴 白丹 刘昕 欧兰香 黄芯 陈坤[7] 王国华[7] 张贺秋[7] 周见远 

机构地区：[1]岳阳市第一人民医院,湖南岳阳414000 [2]中南大学湘雅医院 [3]北京市天坛医院 [4]辽宁省血液中心 [5]北京市佑安医院 [6]湖南景达生物工程有限公司 [7]军事医学科学院基础医学研究所

出　　处：《中国输血杂志》2007年第5期365-367,共3页Chinese Journal of Blood Transfusion

基　　金：国家863计划重点项目(编号:2006AA020907)

摘　　要：目的评价1种国产丙型肝炎病毒核心抗原(HCV-cAg)酶联免疫检测试剂的敏感性以及在临床应用效果。方法采用1种酶联免疫试剂盒(ELISA)检测HCV游离核心抗原,分别对2808名献血者、随机抽取的1099名门诊病人及244名抗-HCV阳性者血清作HCV-cAg检测,再进一步对献血者、门诊病人HCV-cAg阳性血清作HCV-RNA和抗-HCV检测,对244名抗-HCV阳性血清作HCV-RNA检测。结果献血者2808份血清,经HCV-cAg试剂检测出HCV-cAg阳性1例,此例血清HCV-RNA亦为阳性;随机抽取的1099份门诊病人血清标本,检测出HCV-cAg阳性8份,其中抗-HCV阳性5份(5/8),HCV-RNA阳性5份(5/6,有2份HCV-cAg阳性标本因血清不足未作RT-PCR和FQ-PCR);244名抗-HCV阳性的血清中检测出HCV-cAg阳性52份,HCV-RNA阳性49份(49/52),2种方法符合率为94.23%;另外,检测为HCV-cAg阴性的192份标本中,HCV-RNA阳性68份(68/192)。结论该HCV-cAg检测试剂在不同的临床样本中具有很好的应用价值。Objective To evaluate the sensitivity of the enzyme immunoassay （EIA） kits of Hunan Jynda Gene Co. Ltd in detecting hepatitis C virus core antigen. Methods Blood samples from 2808 blood donors, 1909 outpatients, and 244 anti-HCV （＋） cases were randomly selected and hepatitis C virus core antigen （HCV-cAg） was detected with EIA kit. Samples found out to be HCV-cAg（＋） were further tested for HCV-RNA and anti-HCV antibody. Results In 2808 blood donors, one case （0.04%） with both HCV-cAg （＋） and HCV-RNA （＋） was found. In 1099 outpatients, 8 cases （0.73%） of HCV-cAg （＋）was detected, and 5 of them were anti-HCV （＋）. Of these 8 HCV-cAg （＋） cases, 6 were tested for HCV-RNA and 5 were found positive. The other 2 cases of HCV-cAg （＋） were not tested for HCV-RAN because of inadequate specimen. Of the 244 anti-HCV （＋） cases, HCV-cAg （＋） was found in 52, and HCV-RNA （＋） in 49. The other 192 HCV-cAg （-） were also tested for HCV-RNA, and 68 of them were HCV-RNA （＋）. Conclusion EIA kit for the detection of HCV-cAg in human serum or plasma can be used clinically in prevention of the HCV transmission.

关 键 词：丙型肝炎 HCV—cAg ELISA试剂 HCV—RNA 抗-HCV 

分 类 号：R446.61[医药卫生—诊断学] R512.63[医药卫生—临床医学]