摘要
目的系统评价化学发光法检测血清丙型肝炎病毒(HCV)抗体对丙型肝炎的诊断价值。方法计算机检索PubMed、EMbase、h e Cochrane Library(2014年第1期)、CBM、CNKI、VIP和WanFang Data,并手工检索相关期刊,全面收集化学发光法检测血清HCV抗体与金标准(聚合酶链反应或重组免疫印迹法)比较诊断丙型肝炎的相关研究文献,检索时限均为建库至2014年3月1日。由2位评价员按照纳入与排除标准独立筛选文献、提取资料和评价纳入研究的方法学质量后,采用MetaDiSc 1.4软件进行Meta分析。结果最终纳入12个研究,共计1 252例患者。Meta分析结果显示:SEN合并=0.99[95%CI(0.98,0.99),P=0.000 1],SPE合并=0.98[95%CI(0.98,0.99),P=0.000 0],+LR合并=42.53[95%CI(18.05,100.23),P=0.000 0],–LR合并=0.02[95%CI(0.01,0.03),P=0.026 2],DOR合并=3 005.82[95%CI(1 257.08,7 187.29),P=0.006 6]。SROC曲线下面积AUC=0.997 7(SE=0.000 8),Q*=0.983 3(SE=0.003 6)。结论应用化学发光法检测血清HCV抗体诊断丙型肝炎敏感、特异、稳定性好,适合临床推广应用。
Objective To systematically review the diagnostic value of Antibodies to hepatitis C virus （anti-HCV） in serum tested by Chemiluminescence Assay for patients with hepatitis C. Methods Such databases as PubMed, EM- base, The Cochrane Library （Issue 1, 2014）, CBM, CNKI, VIP, and WanFang Data were searched from the date of their establishment to March 1st, 2014, and the relevant journals were also manually searched to collect the studies which evaluated the diagnostic value of anti-HCV in serum tested by chemiluminescence assay for patients with hepatitis C. Literature screening according to the inclusion and exclusion criteria, data extraction and methodological quality assessment were completed by two reviewers independently. Meta-analysis was then conducted using MetaDisc 1.4 software. Results A total of 12 studies involving 1 252 patients were enrolled. The results of meta-analysis indicated that, the pooled sensitivity was 0.99 （95%CI 0.98 to 0.99, P=0.000 1）, and the pooled specificity was 0.98 （95%CI 0.98 to 0.99, P=0.000 0）. The positive likelihood ratio was 42.53 （95%CI 18.05 to 100.23, P=0.000 0） and the negative likelihood ratio was 0.02 （95%CI 0.01 to 0.03, P=0.026 2）. The diagnostic odds ratio was 3 005.82 （95%CI 1 257.08 to 7 187.29, P=0.006）, overall area under the curve （AUC） was 0.9 977 （SE=0.000 8）, and Q^＊ was 0.983 3 （SE=0.003 6）. Conclusion Anti-HCV in serum tested by chemiluminescence assay is sensitive, specific and stable, which is suitable for extensive application in clinics.
出处
《中国循证医学杂志》
CSCD
2014年第6期707-715,共9页
Chinese Journal of Evidence-based Medicine
基金
卫生部医药卫生发展研究中心专项课题(编号:28-1-13)
关键词
丙型肝炎
HCV抗体
化学发光法
META分析
诊断性试验
Hepatitis C
Antibodies to hepatitis C virus （anti-HCV）
Chemiluminescence assay
Meta-analysis
Diagnostic test
