Diagnostic Value of Antibodies to Anti-HCV Tested by Chemiluminescence Assay in Hepatitis C: A Meta-Analysis_Chinese Journal of Evidence-Based Medicine

Authors：

 ZENGYan-hua , MENGCun-ren ,  ZHANGZhao-xia

Medical Laboratory Center, First Affiliated Hospital, Xinjiang Medical University, Urumqi 830054, China;

Corresponding author：

ZHANGZhao-xia, Email: 285715300@qq.com

Keywords：

Hepatitis C; Antibodies to hepatitis C virus(anti-HCV); Chemiluminescence assay; Meta-analysis; Diagnostic test

DOI：

10.7507/1672-2531.20140120

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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, EMbase, The Cochrane Library (Issue 1, 2014), CBM, CNKI, VIP, and WanFang Data were searched from the date of their establishment to March 1^st, 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.

Citation： ZENGYan-hua, MENGCun-ren, ZHANGZhao-xia. Diagnostic Value of Antibodies to Anti-HCV Tested by Chemiluminescence Assay in Hepatitis C: A Meta-Analysis. Chinese Journal of Evidence-Based Medicine, 2014, 14(6): 707-715. doi: 10.7507/1672-2531.20140120 Copy

1.	Miriam JA, Bruce LE, Harold SM, et al. Public health service interagency guidelines for screening donors of blood, plasma, organs, tissues, and semen for evidence of hepatitis B and hepatitis C. American Journal of Infection Control, 1991, 40(RR-4):1-17.
2.	Ghany MG, Strader DB, Thomas DL, et al. Diagnosis, management, and treatment of hepatitis C:an update. Hepatology, 2009, 49:1335-1374.
3.	Alter HJ, Purcell RH, Shin JW, et al. Detection of antibody to hepatitis C virus in prospectively followed transfusion recipients with acute and chronic non-A, non-B hepatitis. N Engl J Med, 1989, 321: 1494-1500.
4.	Kiyosawa K, Sodeyama T, Tanaka E, et al. Interrelationship of blood transfusion, non-A, non-B Hepatitis and hepatocellular carcinoma: analysis by detection of antibody to hepatitis C virus. Hepatology, 1990, 12:671-675.
5.	Tong MJ, El-Farra NS, Reikes AR, et al. Clinical outcomes after transfusion-associated hepatitis C. N Engl J Med, 1995, 332:1463-1466.
6.	Lavanchy D. Evolving epidemiology of hepatitis C virus. Clin Microbiol Infect, 2011, 17:107-115.
7.	Brown RS. Hepatitis C and liver transplantation. Nature, 2005, 436: 973-978.
8.	Deuffic-Burban S, Poyinard T, Sulkowski MS, et al. Estimating the future health burden of chronic hepatitis C and human immunodeficiency virus infection in the United States. Viral Hepat, 2007, 14: 107-115.
9.	Tobler LH, Stramer SL, Lee SR, et al. Impact of HCV 3.0 EIA relative to HCV 2.0 EIA On blood-donor screening. Transfusion, 2003, 43(10):1452-1459.
10.	Japanese Red Cross Non-A, Non-B Hepatitis Research Group. Effect of screening for hepatitis C virus antibody and hepatitis B virus core anti-body on incidence of post-transfusion hepatitis. Lancet, 1991, 338:1040-1041.
11.	Donahue JG, Munoz A, Ness PM, et al. The declining risk of post-transfusion hepatitis C virus infection. N Engl J Med, 1992, 327:369-373.
12.	Strader DB, Wright T, Thomas DL, et al. Diagnosis, management, and treatment of hepatitis C. Hepatology, 2004, 39:1147-1171.
13.	Kim S, Kim J H, Yoon S, et al. Clinical performance evaluation of four automated chemiluminescence immunoassays for hepatitis C virus antibody detection. J Clin Microbiol, 2008, 46(12):3919-3923.
14.	买志刚.丙型肝炎临床检验技术现状与发展.中国卫生检验杂志, 2008, 18(1):190-192.
15.	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.
16.	Liehtinghagen R, Bahr M. Noninvasive diagnosis of fibrosis in chronic liver disease. Expert Re Mol Diagn, 2004, 4(5):715-726.
17.	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.
18.	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.
19.	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):97-100.
20.	Zamora J, Abraira V, Muriel A, et al. Meta-DiSc:a software for metaanalysis of test accuracy data. BMC Med Res Methodol, 2006, 6:31.
21.	Berger A, Regina H, Allwinn R, et al. Evaluation of the new ARCHITECT anti HCV screening test under routine laboratory conditions. Journal of Clinical Virology, 2008, 43(2):158-163.
22.	Dufour DR, Talastas M, Maria DA. Chemiluminescence assay improves specificity of hepatitis C antibody detection. Clinical Chemistry, 2003, 49(6):940-944.
23.	Nahed I, Geoffrey FE, Michael BS. Laboratory eva1uation of a fully automated Chemiluminescence immunoassay for rapid detection of HBsAg, antibodies to HBsAg, and antibodies to hepatitis C virus. J Clin Microbiol, 2004, 42(2):610-607.
24.	Kesli R, Ozdemir M, Kurtoglu MG, et al. Evaluation and comparison of three different anti-hepatitis C virus antibody tests based on chemiluminescence and enzyme-linked immunosorbent assay methods used in the diagnosis of hepatitis C infections in turkey. The Journal of International Medical Research, 2009, 37(5):1420-1429.
25.	Kim S, Kim JH, Yoon S, et al. Clinical performance evaluation of four automated chemiluminescence immunoassays for hepatitis C virus antibody detection. Journal of Clinical Microbiology, 2008, 46(12):3919.
26.	Kita M, Deguchi M, Kagita M, et al. Clinical utility and characteristics of nine anti-HCV antibody screening reagents used in Japan. Clinica y Laboratoria, 2009, 55(1-2):9-22.
27.	汪欣, 吴旋, 赵素萍, 等. 4种检测HCV抗体方法的应用评价.中国社区医师(医学专业), 2012, 14(29):205-206.
28.	谢志贤, 郭健. POCT法与化学发光法检测丙型肝炎抗体的临床评价. 2007年全国免疫学与分子生物学技术新进展研讨会论文集. 2007:324-326.
29.	汤巧, 吴文静, 夏永祥, 等.化学发光法和酶联免疫吸附法检测丙型肝炎病毒抗体的比较分析.国际检验医学杂志, 2011, 32(8):834-835.
30.	易浔飞.化学发光试剂检测丙型肝炎抗体的方法学评价.中华医学会第九次全国检验医学学术会议暨中国医院协会临床检验管理专业委员会第六届全国临床检验实验室管理学术会议论文汇编. 2011:242.
31.	李涛, 罗兵, 金先彬, 等.三种酶免试剂盒和电化学发光试剂盒检测HCV抗体的比较.安徽医药, 2012, 16(8):1092-1094.
32.	金一鸣, 方志红, 曹谊, 等.血液筛查中丙型肝炎病毒检测方法的应用评价.检验医学与临床, 2013, 10(5):552-553.
33.	Lemon SM. Hepatitis C Virus. In:Knipe DM, Howley PM, eds. Fields Virology, 5 edn. Philadelphia, Lippincott Williams & Wilkins, 2007:1253-1304.
34.	Walker CM. Hepatitis C virus. In:Ahmed R, Chen I, eds. Persistent Viral Infections. Chichester, Wiley, 1999:93-115.
35.	EASL International Consensus Conference on Hepatitis C. Consensus Statement. Journal of Hepatology, 1999, 31:3-8.
36.	The Hepatitis C Trust. World Hepatitis Day 2008 News from Around the World. World Health Hepatitis Day News, Update on 23rd May, 2008.
37.	Hyon-Suk Kim. Anti-HCV Signal-to-cutoff ratio in predicting hepatitis C viremia. Korean J Intern Med, 2009, 24(4):299-301.
38.	Ismail N, Fish GE, Smith MB. Laboratory evaluation of a fully automated chemiluminescence immunoassay for rapid detection of HBsAg, antibodies to hbsag, and antibodies to hepatitis C virus. J Clin Microbiol, 2004, 42(2):610-617.
39.	Weber B, Bayer A, Kirch P, et al. Melchior W. Improved detection of hepatitis b virus surface antigen by a new rapid automated assay. J Clin Microbiol, 1999, 37(8):2639-2647.
40.	Jia JD, Hong M, Wei L, et al. Multicentre evaluation of the Elecsys^{^®} hepatitis B surface antigen Ⅱ assay for detection of HBsAg in comparison with other commercially available assays. Med Microbiol Immunol, 2009, 198:263-269.
41.	卢星如, 张皓, 王浩, 等.磁共振成像诊断肺栓塞价值的Meta分析.中国循证医学杂志, 2013, 13(2):160-164.
42.	Habel LA, Capra AM, Oestreicher N, et al. Mammographic density in a multiethnic cohort. Menopause, 2007, 14(5):891-899.
43.	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.
44.	唐婧, 孟存仁, 张朝霞.第三代ELISA试剂检测HCV抗体诊断丙型肝炎价值的Meta分析.中国循证医学杂志, 2013, 13(11):1318-1325.

1. Miriam JA, Bruce LE, Harold SM, et al. Public health service interagency guidelines for screening donors of blood, plasma, organs, tissues, and semen for evidence of hepatitis B and hepatitis C. American Journal of Infection Control, 1991, 40(RR-4):1-17.
2. Ghany MG, Strader DB, Thomas DL, et al. Diagnosis, management, and treatment of hepatitis C:an update. Hepatology, 2009, 49:1335-1374.
3. Alter HJ, Purcell RH, Shin JW, et al. Detection of antibody to hepatitis C virus in prospectively followed transfusion recipients with acute and chronic non-A, non-B hepatitis. N Engl J Med, 1989, 321: 1494-1500.
4. Kiyosawa K, Sodeyama T, Tanaka E, et al. Interrelationship of blood transfusion, non-A, non-B Hepatitis and hepatocellular carcinoma: analysis by detection of antibody to hepatitis C virus. Hepatology, 1990, 12:671-675.
5. Tong MJ, El-Farra NS, Reikes AR, et al. Clinical outcomes after transfusion-associated hepatitis C. N Engl J Med, 1995, 332:1463-1466.
6. Lavanchy D. Evolving epidemiology of hepatitis C virus. Clin Microbiol Infect, 2011, 17:107-115.
7. Brown RS. Hepatitis C and liver transplantation. Nature, 2005, 436: 973-978.
8. Deuffic-Burban S, Poyinard T, Sulkowski MS, et al. Estimating the future health burden of chronic hepatitis C and human immunodeficiency virus infection in the United States. Viral Hepat, 2007, 14: 107-115.
9. Tobler LH, Stramer SL, Lee SR, et al. Impact of HCV 3.0 EIA relative to HCV 2.0 EIA On blood-donor screening. Transfusion, 2003, 43(10):1452-1459.
10. Japanese Red Cross Non-A, Non-B Hepatitis Research Group. Effect of screening for hepatitis C virus antibody and hepatitis B virus core anti-body on incidence of post-transfusion hepatitis. Lancet, 1991, 338:1040-1041.
11. Donahue JG, Munoz A, Ness PM, et al. The declining risk of post-transfusion hepatitis C virus infection. N Engl J Med, 1992, 327:369-373.
12. Strader DB, Wright T, Thomas DL, et al. Diagnosis, management, and treatment of hepatitis C. Hepatology, 2004, 39:1147-1171.
13. Kim S, Kim J H, Yoon S, et al. Clinical performance evaluation of four automated chemiluminescence immunoassays for hepatitis C virus antibody detection. J Clin Microbiol, 2008, 46(12):3919-3923.
14. 买志刚.丙型肝炎临床检验技术现状与发展.中国卫生检验杂志, 2008, 18(1):190-192.
15. 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.
16. Liehtinghagen R, Bahr M. Noninvasive diagnosis of fibrosis in chronic liver disease. Expert Re Mol Diagn, 2004, 4(5):715-726.
17. 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.
18. 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.
19. 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):97-100.
20. Zamora J, Abraira V, Muriel A, et al. Meta-DiSc:a software for metaanalysis of test accuracy data. BMC Med Res Methodol, 2006, 6:31.
21. Berger A, Regina H, Allwinn R, et al. Evaluation of the new ARCHITECT anti HCV screening test under routine laboratory conditions. Journal of Clinical Virology, 2008, 43(2):158-163.
22. Dufour DR, Talastas M, Maria DA. Chemiluminescence assay improves specificity of hepatitis C antibody detection. Clinical Chemistry, 2003, 49(6):940-944.
23. Nahed I, Geoffrey FE, Michael BS. Laboratory eva1uation of a fully automated Chemiluminescence immunoassay for rapid detection of HBsAg, antibodies to HBsAg, and antibodies to hepatitis C virus. J Clin Microbiol, 2004, 42(2):610-607.
24. Kesli R, Ozdemir M, Kurtoglu MG, et al. Evaluation and comparison of three different anti-hepatitis C virus antibody tests based on chemiluminescence and enzyme-linked immunosorbent assay methods used in the diagnosis of hepatitis C infections in turkey. The Journal of International Medical Research, 2009, 37(5):1420-1429.
25. Kim S, Kim JH, Yoon S, et al. Clinical performance evaluation of four automated chemiluminescence immunoassays for hepatitis C virus antibody detection. Journal of Clinical Microbiology, 2008, 46(12):3919.
26. Kita M, Deguchi M, Kagita M, et al. Clinical utility and characteristics of nine anti-HCV antibody screening reagents used in Japan. Clinica y Laboratoria, 2009, 55(1-2):9-22.
27. 汪欣, 吴旋, 赵素萍, 等. 4种检测HCV抗体方法的应用评价.中国社区医师(医学专业), 2012, 14(29):205-206.
28. 谢志贤, 郭健. POCT法与化学发光法检测丙型肝炎抗体的临床评价. 2007年全国免疫学与分子生物学技术新进展研讨会论文集. 2007:324-326.
29. 汤巧, 吴文静, 夏永祥, 等.化学发光法和酶联免疫吸附法检测丙型肝炎病毒抗体的比较分析.国际检验医学杂志, 2011, 32(8):834-835.
30. 易浔飞.化学发光试剂检测丙型肝炎抗体的方法学评价.中华医学会第九次全国检验医学学术会议暨中国医院协会临床检验管理专业委员会第六届全国临床检验实验室管理学术会议论文汇编. 2011:242.
31. 李涛, 罗兵, 金先彬, 等.三种酶免试剂盒和电化学发光试剂盒检测HCV抗体的比较.安徽医药, 2012, 16(8):1092-1094.
32. 金一鸣, 方志红, 曹谊, 等.血液筛查中丙型肝炎病毒检测方法的应用评价.检验医学与临床, 2013, 10(5):552-553.
33. Lemon SM. Hepatitis C Virus. In:Knipe DM, Howley PM, eds. Fields Virology, 5 edn. Philadelphia, Lippincott Williams & Wilkins, 2007:1253-1304.
34. Walker CM. Hepatitis C virus. In:Ahmed R, Chen I, eds. Persistent Viral Infections. Chichester, Wiley, 1999:93-115.
35. EASL International Consensus Conference on Hepatitis C. Consensus Statement. Journal of Hepatology, 1999, 31:3-8.
36. The Hepatitis C Trust. World Hepatitis Day 2008 News from Around the World. World Health Hepatitis Day News, Update on 23rd May, 2008.
37. Hyon-Suk Kim. Anti-HCV Signal-to-cutoff ratio in predicting hepatitis C viremia. Korean J Intern Med, 2009, 24(4):299-301.
38. Ismail N, Fish GE, Smith MB. Laboratory evaluation of a fully automated chemiluminescence immunoassay for rapid detection of HBsAg, antibodies to hbsag, and antibodies to hepatitis C virus. J Clin Microbiol, 2004, 42(2):610-617.
39. Weber B, Bayer A, Kirch P, et al. Melchior W. Improved detection of hepatitis b virus surface antigen by a new rapid automated assay. J Clin Microbiol, 1999, 37(8):2639-2647.
40. Jia JD, Hong M, Wei L, et al. Multicentre evaluation of the Elecsys^{^®} hepatitis B surface antigen Ⅱ assay for detection of HBsAg in comparison with other commercially available assays. Med Microbiol Immunol, 2009, 198:263-269.
41. 卢星如, 张皓, 王浩, 等.磁共振成像诊断肺栓塞价值的Meta分析.中国循证医学杂志, 2013, 13(2):160-164.
42. Habel LA, Capra AM, Oestreicher N, et al. Mammographic density in a multiethnic cohort. Menopause, 2007, 14(5):891-899.
43. 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.
44. 唐婧, 孟存仁, 张朝霞.第三代ELISA试剂检测HCV抗体诊断丙型肝炎价值的Meta分析.中国循证医学杂志, 2013, 13(11):1318-1325.

Chinese Journal of Evidence-Based Medicine

Diagnostic Value of Antibodies to Anti-HCV Tested by Chemiluminescence Assay in Hepatitis C: A Meta-Analysis

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