丙型肝炎病毒核心抗原检测应用于无偿献血者筛检的评价  

Evaluation Of HCV core antigen detection in screening blood donors for HCV infections

作　　者：谭春泽[1] 

机构地区：[1]解放军181医院输血科解放军桂林血站,广西桂林541002

出　　处：《中国输血杂志》2014年第12期1312-1314,共3页Chinese Journal of Blood Transfusion

摘　　要：目的评估丙型肝炎病毒核心抗原酶联免疫吸附技术(HCV-cAg ELISA)应用于无偿献血者筛检的价值。方法用HCV-cAg EIISA检测试剂(考核试剂)及间接法抗-HCV检测试剂(参考试剂)分别对22 000(人)份无偿献血者血液标本检测,二者结果不一致的标本以HCV RT-PCR法检测结果为最终判定标准;对所得数据综合分析评价。结果考核试剂和参考试剂的灵敏度、特异度、阳性预测值、假阳性率、约登指数及漏检率分别为98.46%(64/65)vs 78.46%(51/65)、99.99%(21 934/21 935)vs 99.89%(21 911/21 935)、98.46%(64/65)vs 99.99%(21 934/21 935)、0.004 6%(1/21 935)vs 0.11%(24/21 935)、0.984 5 vs 0.783 5、1.54%(1/65)vs 21.54%(14/65)。结论 HCV-cAg ELISA检测较间接法抗-HCV ELISA提高了检测的灵敏度,缩短了窗口期,降低了假阳性率,在无偿献血者血液筛检中具有应用价值。Objective To investigate the role of HCV core antigen （ HCV-cAg ） detection in screening donor for HCV infection using ELISA. Methods The HCVeAg EIISA detection reagent （ testing reagent） and anti-HCV reagent （ ：＇efer- enee reagent） were used to test on 22,000 donated serum samples. Specimens with conflicting results between these two methods were further examined by gHCV RT-PCR. Results The sensitivities of the testing and reference reagents were 98. 46% （64/65） and 78.46% （51/65） , respectively, while the speeificities of examination and reference reagent were 99. 99% （21,934/ 21,935） and 99.89 % （21,911/21,935）, respectively. The positive predictive values of testing and ：-efer- ence reagent were 98.46% （64/65） and 99.99% （21934/21935）, and the false positive rates of testing and reference rea- gent were 0.0046% （ 1/21,935 ） and 0.11% （24/21,935）. The Youden＇s indices of the testing and reference reagent were 0. 9845 and 0. 7835. The omission factors of testing and reference reagent were 1.54% （ 1/65 ） and 21.54% （ 14/65 ）, re- spectively. Conclusion The HCV-cAg test assay can improve the sensitivity for detection of HCV infection, shorten the window period and reduce false positive rate. Its application in screening blood donor for HCV infection may significantly re- duce the HCV infection derived from blood transfusion.

关 键 词：丙型肝炎病毒 HCV-CAG 无偿献血者 血液筛检 ELISA 

分 类 号：R446.62[医药卫生—诊断学] R512.63[医药卫生—临床医学]