Value of Anti-HCV in Serum Tested by Third-Generation Enzyme-linked Immunosorbent Assay in Diagnosis of Hepatitis C: A Meta-Analysis_Chinese Journal of Evidence-Based Medicine

Authors：

TANG Jing , MENG Cunren ,  ZHANG Zhaoxia

Department of Laboratory Medicine, The First Affiliated Hospital of Xinjiang Medical University, Urumqi 830054, China;

Corresponding author：

ZHANG Zhaoxia, Email: 285715300@qq.com

Keywords：

Hepatitis C; Anti-HCV; Enzyme-linked immunosorbent assay (ELISA); Meta-analysis; Diagnostic test

DOI：

10.7507/1672-2531.20130227

Video：

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Abstract Full text Figures/Tables Video References Cited by

Objective 　To systematically review the diagnostic value of anti-HCV in serum tested by the third-generation enzyme-linked immunosorbent assay (ELISA 3) in patients with hepatitis C.
Methods 　Such databases as PubMed, MEDLINE, EMbase, The Cochrane Library (Issue 1, 2013), EBSCO, CBM, CNKI, VIP and WanFang Data were electronically and comprehensively searched for relevant studies on the diagnostic value of anti-HCV in serum tested by ELISA 3 in patients with hepatitis C from inception to January 1st, 2013. Relevant journals were also manually retrieved. QUADAS items were used to evaluate the quality of the included studies. Then meta-analysis was performed using Meta-Disc 1.4 software to calculate pooled effect size in sensitivity (SEN), specificity (SPE), likelihood ratio (±LR), diagnostic odds ratio (DOR) and summary receiver operating characteristic curve (SROC curve), and area under the curve (AUC) as well.
Results 　Finally, nine studies were included, involving 1 182 patients with hepatitis C diagnosed by the gold standard and 4 764 patients with non-hepatitis C diseases. The results of meta-analysis using random model showed (SEN=0.96, 95%CI 0.95 to 0.97; SPE=0.96, 95%CI 0.96 to 0.97; +LR=42.21, 95%CI 10.23 to 174.23; –LR=0.02, 95%CI 0.01 to 0.09; DOR=1 635.89, 95%CI 372.37 to 7 186.83; AUC=0.996 5).
Conclusion 　Anti-HCV in serum tested by ELISA 3 has fairly high value in the diagnosis of patients with hepatitis C.

Citation： TANG Jing,MENG Cunren,ZHANG Zhaoxia. Value of Anti-HCV in Serum Tested by Third-Generation Enzyme-linked Immunosorbent Assay in Diagnosis of Hepatitis C: A Meta-Analysis. Chinese Journal of Evidence-Based Medicine, 2013, 13(11): 1318-1325. doi: 10.7507/1672-2531.20130227 Copy

1.	王晓艳, 伊瑶, 陈斯勇, 等. 丙型肝炎病毒的病毒学检测方法. 中华实验和临床病毒学杂志, 2011, 25(2): 158-161.
2.	托马斯(Lothar Thomas). 临床实验诊断学. 上海: 上海科学技术出版社, 2004: 1277-1281.
3.	马文昭. 丙型肝炎病毒抗体的检测及临床意义. 中国现代医生, 2008, 46(13): 159.
4.	张言超, 陈明, 李强, 等. HCV RNA和抗-HCV联合检测的诊断意义. 徐州医学院学报, 2010, 30(8): 536-537.
5.	杨东亮. 丙型肝炎的病毒检测指标及其临床意义. 中华肝脏病杂志, 2004, 12(2): 104.
6.	Liehtinghagen R, Bahr M. Noninvasive diagnosis of fibrosis in chronic liver disease. Expert Re Mol Diagn, 2004, 4(5): 715-726.
7.	李芸芝, 马彬, 杨克虎, 等. MRI和骨扫描对乳腺癌骨转移诊断价值的Meta分析. 中国循证医学杂志, 2010, 10(10): 1159-1163.
8.	Whiting P, Rutjes AW, Reitsma JB, 等. QUADAS的制定: 用于系统评价中评价诊断性研究质量的工具(译文). 中国循证医学杂志, 2007, 7(4): 296-306.
9.	Whiting P, Weswood ME, Rutjes AW, 等. QUADAS评价: 一种用于诊断性研究的质量评价工具 (修订版) (译文). 中国循证医学杂志, 2007, 7(7): 531-536.
10.	张天嵩, 钟文昭. Meta-Disc软件在诊断试验Meta分析中的应用. 循证医学, 2008, 8(2): 97-108.
11.	Tashkandy MA, Khodari YA, Ibrahim AM, et al. Evaluation of the available anti-HCV antibody Detection Tests and RT-PCR assay in the Diagnosis of Hepatitis C Virus Infection. Saudi J Kidney Dis Transplant, 2007, 18(4): 523-531.
12.	Swellam M, Mahmoud MS, Ali AA. Diagnosis of Hepatitis C Virus Infection by Enzyme-linked Immunosorbent Assay and Reverse Transcriptase-Nested Polymerase Chain Reaction: A comparative Evaluation. IUBMB Life, 2011, 63(6): 430-434.
13.	Makhlough A, Jamshidi M, Mahadvi MR. Hepatitis C prevalence studied by polymerase chain reaction and serological methods in haemodialysis patients in Mazandaran, Iran. Singapore Med J, 2008, 49(11): 921.
14.	Vrielink H, Zaaijer HL, Reesink HW, et al. Sensitivity and specificity of three third-generation anti-hepatitis C virus ELISAs. Vox Sang, 1995, 69: 14-17.
15.	Huber KR, Sebesta C, Bauer K. Detection of common hepatitis C virus subtypes with a third-generation enzyme immunoassay. Hepatology, 1996, 24(3): 471-473.
16.	Stuyver L, Claeys H, Wyseur A, et al. Hepatitis C virus in a hemodialysis unit: molecular evidence for nosocomial transmission. Kidney Int, 1996, 49(3): 889-895.
17.	王香玲, 王小利, 李妙羡, 等. 丙型肝炎病原学检测的临床应用效果评价. 西安交通大学学报(医学版), 2004, 25(3): 296-298.
18.	黄莲芬. 不同方法测定对丙型肝炎诊断的影响分析. 临床和实验医学杂志, 2011, 10(4): 289.
19.	文汉成, 安社刚, 张红芳. 抗-HCV与HCV-RNA检测结果不一致原因分析. 实用医技杂志, 2004, 11(9): 1707-1708.
20.	Hadziyannis SJ, Sette H Jr, MorganTR, et al. Peginterfer-on-alpha 2a and ribavirin Combination therapy in chronic hepatitis C. Ann Interm Med, 2004, 140(10): 346-355.
21.	赵守松. 丙型肝炎的实验诊断进展. 安徽医学. 2001, 22(1): 2-3.
22.	袁小东. 钼靶、磁共振及核素显像诊断乳腺癌准确性的系统评价及相关统计学技术探讨. 上海: 第二军医大学, 2009.
23.	Patrick M, Bossuyt JB, Reitsma DE, et al. The STARD statement for reporting studies of diagnosis accuracy: explanation and elaboration. Croat Med J, 2003, 44: 639-650.
24.	Tackmann R, Schuetz G, Hamm B, et al. Quality of the reporting of diagnostic accuracy studies: STARD(Standards for the Reporting of Diagnostic accuracy studies). Rofo, 2010, 182(8): 655-659.
25.	张志明, 张宗久, 李培杰, 等. 结核分枝杆菌耐乙胺丁醇诊断试验的系统评价. 中国循证医学杂志, 2010, 10(12): 1456-1460.

1. 王晓艳, 伊瑶, 陈斯勇, 等. 丙型肝炎病毒的病毒学检测方法. 中华实验和临床病毒学杂志, 2011, 25(2): 158-161.
2. 托马斯(Lothar Thomas). 临床实验诊断学. 上海: 上海科学技术出版社, 2004: 1277-1281.
3. 马文昭. 丙型肝炎病毒抗体的检测及临床意义. 中国现代医生, 2008, 46(13): 159.
4. 张言超, 陈明, 李强, 等. HCV RNA和抗-HCV联合检测的诊断意义. 徐州医学院学报, 2010, 30(8): 536-537.
5. 杨东亮. 丙型肝炎的病毒检测指标及其临床意义. 中华肝脏病杂志, 2004, 12(2): 104.
6. Liehtinghagen R, Bahr M. Noninvasive diagnosis of fibrosis in chronic liver disease. Expert Re Mol Diagn, 2004, 4(5): 715-726.
7. 李芸芝, 马彬, 杨克虎, 等. MRI和骨扫描对乳腺癌骨转移诊断价值的Meta分析. 中国循证医学杂志, 2010, 10(10): 1159-1163.
8. Whiting P, Rutjes AW, Reitsma JB, 等. QUADAS的制定: 用于系统评价中评价诊断性研究质量的工具(译文). 中国循证医学杂志, 2007, 7(4): 296-306.
9. Whiting P, Weswood ME, Rutjes AW, 等. QUADAS评价: 一种用于诊断性研究的质量评价工具 (修订版) (译文). 中国循证医学杂志, 2007, 7(7): 531-536.
10. 张天嵩, 钟文昭. Meta-Disc软件在诊断试验Meta分析中的应用. 循证医学, 2008, 8(2): 97-108.
11. Tashkandy MA, Khodari YA, Ibrahim AM, et al. Evaluation of the available anti-HCV antibody Detection Tests and RT-PCR assay in the Diagnosis of Hepatitis C Virus Infection. Saudi J Kidney Dis Transplant, 2007, 18(4): 523-531.
12. Swellam M, Mahmoud MS, Ali AA. Diagnosis of Hepatitis C Virus Infection by Enzyme-linked Immunosorbent Assay and Reverse Transcriptase-Nested Polymerase Chain Reaction: A comparative Evaluation. IUBMB Life, 2011, 63(6): 430-434.
13. Makhlough A, Jamshidi M, Mahadvi MR. Hepatitis C prevalence studied by polymerase chain reaction and serological methods in haemodialysis patients in Mazandaran, Iran. Singapore Med J, 2008, 49(11): 921.
14. Vrielink H, Zaaijer HL, Reesink HW, et al. Sensitivity and specificity of three third-generation anti-hepatitis C virus ELISAs. Vox Sang, 1995, 69: 14-17.
15. Huber KR, Sebesta C, Bauer K. Detection of common hepatitis C virus subtypes with a third-generation enzyme immunoassay. Hepatology, 1996, 24(3): 471-473.
16. Stuyver L, Claeys H, Wyseur A, et al. Hepatitis C virus in a hemodialysis unit: molecular evidence for nosocomial transmission. Kidney Int, 1996, 49(3): 889-895.
17. 王香玲, 王小利, 李妙羡, 等. 丙型肝炎病原学检测的临床应用效果评价. 西安交通大学学报(医学版), 2004, 25(3): 296-298.
18. 黄莲芬. 不同方法测定对丙型肝炎诊断的影响分析. 临床和实验医学杂志, 2011, 10(4): 289.
19. 文汉成, 安社刚, 张红芳. 抗-HCV与HCV-RNA检测结果不一致原因分析. 实用医技杂志, 2004, 11(9): 1707-1708.
20. Hadziyannis SJ, Sette H Jr, MorganTR, et al. Peginterfer-on-alpha 2a and ribavirin Combination therapy in chronic hepatitis C. Ann Interm Med, 2004, 140(10): 346-355.
21. 赵守松. 丙型肝炎的实验诊断进展. 安徽医学. 2001, 22(1): 2-3.
22. 袁小东. 钼靶、磁共振及核素显像诊断乳腺癌准确性的系统评价及相关统计学技术探讨. 上海: 第二军医大学, 2009.
23. Patrick M, Bossuyt JB, Reitsma DE, et al. The STARD statement for reporting studies of diagnosis accuracy: explanation and elaboration. Croat Med J, 2003, 44: 639-650.
24. Tackmann R, Schuetz G, Hamm B, et al. Quality of the reporting of diagnostic accuracy studies: STARD(Standards for the Reporting of Diagnostic accuracy studies). Rofo, 2010, 182(8): 655-659.
25. 张志明, 张宗久, 李培杰, 等. 结核分枝杆菌耐乙胺丁醇诊断试验的系统评价. 中国循证医学杂志, 2010, 10(12): 1456-1460.

Chinese Journal of Evidence-Based Medicine

Value of Anti-HCV in Serum Tested by Third-Generation Enzyme-linked Immunosorbent Assay in Diagnosis of Hepatitis C: A Meta-Analysis

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