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

Video：

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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.	買志剛.丙型肝炎臨床檢驗技術現狀與發展.中國衛生檢驗雜志, 2008, 18(1):190-192.
15.	楊東亮.丙型肝炎的病毒檢測指標及其臨床意義.中華肝臟病雜志, 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:用于系統評價中評價診斷性研究質量的工具(譯文).中國循證醫學雜志, 2007, 7(4):296-306.
18.	Whiting P, Weswood ME, Rutjes AW, 等. QUADAS評價:一種用于診斷性研究的質量評價工具(修訂版) (譯文).中國循證醫學雜志, 2007, 7(7):531-536.
19.	張天嵩, 鐘文昭. Meta-DiSc軟件在診斷試驗Meta分析中的應用.循證醫學, 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, 吳旋, 趙素萍, 等. 4種檢測HCV抗體方法的應用評價.中國社區醫師(醫學專業), 2012, 14(29):205-206.
28.	謝志賢, 郭健. POCT法與化學發光法檢測丙型肝炎抗體的臨床評價. 2007年全國免疫學與分子生物學技術新進展研討會論文集. 2007:324-326.
29.	湯巧, 吳文靜, 夏永祥, 等.化學發光法和酶聯免疫吸附法檢測丙型肝炎病毒抗體的比較分析.國際檢驗醫學雜志, 2011, 32(8):834-835.
30.	易潯飛.化學發光試劑檢測丙型肝炎抗體的方法學評價.中華醫學會第九次全國檢驗醫學學術會議暨中國醫院協會臨床檢驗管理專業委員會第六屆全國臨床檢驗實驗室管理學術會議論文匯編. 2011:242.
31.	李濤, 羅兵, 金先彬, 等.三種酶免試劑盒和電化學發光試劑盒檢測HCV抗體的比較.安徽醫藥, 2012, 16(8):1092-1094.
32.	金一鳴, 方志紅, 曹誼, 等.血液篩查中丙型肝炎病毒檢測方法的應用評價.檢驗醫學與臨床, 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.	盧星如, 張皓, 王浩, 等.磁共振成像診斷肺栓塞價值的Meta分析.中國循證醫學雜志, 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, 張朝霞.第三代ELISA試劑檢測HCV抗體診斷丙型肝炎價值的Meta分析.中國循證醫學雜志, 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. 買志剛.丙型肝炎臨床檢驗技術現狀與發展.中國衛生檢驗雜志, 2008, 18(1):190-192.
15. 楊東亮.丙型肝炎的病毒檢測指標及其臨床意義.中華肝臟病雜志, 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:用于系統評價中評價診斷性研究質量的工具(譯文).中國循證醫學雜志, 2007, 7(4):296-306.
18. Whiting P, Weswood ME, Rutjes AW, 等. QUADAS評價:一種用于診斷性研究的質量評價工具(修訂版) (譯文).中國循證醫學雜志, 2007, 7(7):531-536.
19. 張天嵩, 鐘文昭. Meta-DiSc軟件在診斷試驗Meta分析中的應用.循證醫學, 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, 吳旋, 趙素萍, 等. 4種檢測HCV抗體方法的應用評價.中國社區醫師(醫學專業), 2012, 14(29):205-206.
28. 謝志賢, 郭健. POCT法與化學發光法檢測丙型肝炎抗體的臨床評價. 2007年全國免疫學與分子生物學技術新進展研討會論文集. 2007:324-326.
29. 湯巧, 吳文靜, 夏永祥, 等.化學發光法和酶聯免疫吸附法檢測丙型肝炎病毒抗體的比較分析.國際檢驗醫學雜志, 2011, 32(8):834-835.
30. 易潯飛.化學發光試劑檢測丙型肝炎抗體的方法學評價.中華醫學會第九次全國檢驗醫學學術會議暨中國醫院協會臨床檢驗管理專業委員會第六屆全國臨床檢驗實驗室管理學術會議論文匯編. 2011:242.
31. 李濤, 羅兵, 金先彬, 等.三種酶免試劑盒和電化學發光試劑盒檢測HCV抗體的比較.安徽醫藥, 2012, 16(8):1092-1094.
32. 金一鳴, 方志紅, 曹誼, 等.血液篩查中丙型肝炎病毒檢測方法的應用評價.檢驗醫學與臨床, 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. 盧星如, 張皓, 王浩, 等.磁共振成像診斷肺栓塞價值的Meta分析.中國循證醫學雜志, 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, 張朝霞.第三代ELISA試劑檢測HCV抗體診斷丙型肝炎價值的Meta分析.中國循證醫學雜志, 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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