丙型肝炎病毒抗体复查策略的研究  

Study on the Rechecked Strategy of Antibody to Hepatitis C Virus

作　　者：张菁[1] 邵春燕[1] 卓海龙[1] 王海平[1] 骆群[1] 

机构地区：[1]中国人民解放军第三0七医院输血科,100071

出　　处：《临床输血与检验》2017年第4期358-361,共4页Journal of Clinical Transfusion and Laboratory Medicine

摘　　要：目的探讨化学发光法(chemiluminescence immunoassay,CLIA)联合酶联免疫法(enzyme linked immunosorbent assay,ELISA)检测丙型肝炎病毒抗体(抗-HCV)的复查策略。方法采用CLIA法筛选出抗-HCV S/CO﹥0.40的血清样本,再采用2种ELISA法试剂进行复查,对至少1种试剂检测结果在临界值(CLIA法S/CO﹥0.90,ELISA法S/CO﹥0.80)以上的样本,采用荧光定量聚合酶链反应(realtime fluorescence quantitative PCR,FQ-PCR)方法进行HCV核酸定量(HCV RNA)。结果从本院临床患者中筛选出CLIA法抗-HCV S/CO﹥0.40的样本进行ELISA法检测,至少1种试剂检测结果在临界值以上的血清样本201例,其中强生CLIA、索林ELISA和科华ELISA法阳性率分别为2.5%(150/5 800)、1.6%(96/5 800)和1.5%(89/5 800)。CLIA及2种ELISA法试剂检测结果均呈阳性的样本75例,阳性率为1.3%(75/5800);FQ-PCR法检测结果阳性51例,阳性率为0.9%(51/5 800)。CLIA法检测抗-HCV S/CO﹥0.40且<0.90的样本有40份,CLIA法检测抗-HCV S/CO﹥0.90且<0.99的样本有8份;CLIA法检测抗-HCV S/CO≥1.0的样本有153例,其中S/CO 1.00~5.00的样本有66例,S/CO 5.01~10.00的样本16例,S/CO 10.01~20.00的样本5例,S/CO﹥20.00的样本66例。结论对CLIA法检测抗-HCV S/CO﹥0.40且<0.90的样本未发现漏检,建议直接发放阴性结果,减少试剂浪费;对CLIA和ELISA法检测抗-HCV阳性样本进行HCV RNA检测,并结合临床表现进行诊断及疗效评价。Objective To Investigate the rechecked strategy of chemiluminescence immunoassay（CLIA） combined with enzyme linked immunosorbent assay（ELISA）in order to detect Hepatitis C virus antibodies. Methods Two hundred and one sera samples of CLIA anti-HCV S/CO﹥0.40 were collected from the patients by ELISA. and the samples over the cutoff value with at least one reagent detection were checked for HCV RNA by realtime fluorescence quantitative PCR（FQ-PCR） . Results Among the positive 201 samples,CLIA provided by Johnson,ELISA by MUREX,and ELISA by Kehua companies revealed positivities of 2.5％,1.6%,and 1.5%,respectively. There were 75 （1.3%,75/5 800）samples that had both CLIA and two ELISA reagents positive detections. FQ-PCR positive detections were noted in 51（0.9%,51/5 800）samples. Forty samples exhibited anti-HCV S/CO﹥0.40 and 〈0.90 in CLIA detection. Eight samples showed anti-HCVS/CO﹥0.90 and 〈0.99 in CLIA detection. There were 153 samples that revealed the anti-HCV S/CO≥1.0 in CLIA detection,among them,66 samples indicated S/CO 1.00-5.00,16 samples,S/CO 5.01-10.00; 5 samples,S/CO 10.01-20.00; and 66 samples,S/CO﹥20.00. Conclusion CLIA is reliable for detection of anti- HCV with S/CO﹥0.40 and 〈0.90. HCV RNA detection is useful for laboratory diagnosis and treatment evaluation in the samples that have showed positive anti-HCV by using CLIA and ELISA.

关 键 词：化学发光法 酶联免疫法 丙型肝炎病毒抗体 

分 类 号：R446.11[医药卫生—诊断学] R512.63[医药卫生—临床医学]