丙型病毒性肝炎抗体检测与HCV高敏核酸检测对病毒性丙型肝炎的筛查价值研究  

A Study on the Value of HCV Serological Antibody and High-sensitivity HCV RNA for Screening and Detection of Viral Hepatitis C

作　　者：谢骊 蔡雷鸣 冯颖[1] 段玉萍 厉倩 XIE Li;CAI Leiming;FENG Ying;DUAN Yuping;LI Qian(Department of Clinical Laboratory,Wusong Central Hospital,Baoshan District,Shanghai 200940,China)

机构地区：[1]复旦大学附属中山医院吴淞医院检验科,上海200940

出　　处：《标记免疫分析与临床》2024年第3期456-459,467,共5页Labeled Immunoassays and Clinical Medicine

基　　金：上海市宝山区医学重点专科(编号:BSZK-2023-A18);宝山区卫生健康委优青(育才)计划资助。

摘　　要：目的通过对本院2019年1月至2022年9月需进行手术、输血或其他侵入性医疗服务的住院患者的HCV血清学抗体及高敏HCV RNA筛查结果进行回顾性分析,探讨丙型病毒性肝炎抗体检测与HCV高敏核酸检测对病毒性丙型肝炎的筛查检测价值。方法对本院相关住院患者进行Elecsys Anti-HCV II或(和)高敏HCV RNA检测,统计分析其检测结果。结果HCV血清学抗体检测22443人次,阳性率为0.68%,阳性COI中位数为38.4(1.0~165)。高敏HCV RNA检测34628人次,阳性率0.30%,阳性病毒载量中位数为1.00×10^(6)IU/mL(3.50×10^(1)~4.00×10^(7)IU/mL)。两种方法学均显示45~59岁人群阳性率显著高于其他人群(P<0.001)。两种检测有重合的样本共17785人次,HCV抗体血清学阳性率为0.70%。高敏HCV RNA阳性率0.22%,如以高敏HCV RNA为丙型肝炎现症感染的标准,HCV抗体血清学检测HCV现症感染的灵敏度为100.00%(95%CI 89.09%~100.00%),特异性为99.52%(95%CI 99.41%~99.61%),现症感染阳性预测期PPV为32.00%(95%CI 23.82%~40.18%),阴性预期值为100.00%。HCV抗体血清学检测COI值与高敏HCV RNA检测的病毒载量无线性相关性,COI<10和COI>100的HCV RNA阳性率低。结论HCV抗体检测和高敏HCV RNA均为有效的丙型肝炎筛查手段,需进一步加强对重点人群的丙型肝炎感染管理。Objective Toretrospectively assess the outcomes of HCV serological antibody and high-sensitivity HCV RNA testing on inpatients requiring surgery,blood transfusion,or other invasive medical services at our hospital from January,2019 to September,2022 in order to assess their values.To further study the value of hepatitis C antibody detection and HCV highly sensitive nucleic acid detection in screening and detection of viral hepatitis C.Methods Elecsys Anti-HCV II or/and high-sensitivity HCV RNA detection was performed on relevant inpatients in our hospital,and the detection results were statistically analyzed.Results 2443 people were tested for HCV serological antibody,the positive rate was 0.68%,and the median positive COI was 38.4(1.00-165).High-sensitivity HCV RNA was detected for 34,628 people,with a positive rate of 0.30%.The median positive viral load was 1.00×10^(6)IU/mL(3.50×10^(1)-4.00×10^(7)IU/mL).The 45-59-year-old population exhibited a significantly higher positive rate than other populations,as demonstrated by both methodologies(P<0.001).A total of 17,785 samples were overlapped by the two tests,and the HCV antibody serological positive rate was 0.70%.The positive rate of high-sensitivity HCV RNA was 0.22%.If high-sensitivity HCV RNA was used as the standard for current hepatitis C infection,the sensitivity of HCV antibody serology to detect HCV current infection was 100.00%(95%CI 89.09%-100.00%),specificity,the degree of accuracy was 99.52%(95%CI 99.41%-99.61%),the positive predictive period PPV of current infection was 32.00%(95%CI 23.82%-40.18%),and the negative predictive value was 100.00%.No linear relationship exists between the COI of HCV antibody serological detection and the viral load of high-sensitivity HCV RNA detection,and the rate of HCV RNA being positive when COI was less than 10 and higher than 100 was low.Conclusion HCV antibody detection and high-sensitivity HCV RNA are both effective screening methods for hepatitis C,and it is necessary to further strengthen the management of h

关 键 词：丙型肝炎 丙型肝炎病毒抗体 丙型肝炎病毒RNA 发光免疫标记 核酸检测 

分 类 号：R512.63[医药卫生—内科学]