Value of HBV Pre-S1Ag Tested by Enzyme-linked Immunosorbent Assay in Diagnosis of Hepatitis B Virus Replication: A Meta-Analysis_Chinese Journal of Evidence-Based Medicine

Authors：

 WANGXiao-cun ¹ , TANGJing ² ,  WUJun ¹

1. Institute of Public Health, Xinjiang Medical University, Urumqi 830054, China;
2. Center of Laboratory Medicine, First Affiliated Hospital of Xinjiang Medical University, Urumqi 830054, China;

Corresponding author：

WUJun, Email: wuj1997@sohu.com

Keywords：

Hepatitis B; HBV Pre-S1Ag; Enzyme-linked immunosorbent assay (ELISA); Meta-analysis; Diagnostic test

DOI：

10.7507/1672-2531.20140214

Video：

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Objective To systematically review the diagnostic value of HBV Pre-S1Ag tested by enzyme-linked immunosorbent assay (ELISA) in patients with hepatitis B virus replication. Methods Such databases as PubMed, EMbase, The Cochrane Library (Issue 3, 2014), CBM, CNKI, VIP and WanFang Data were electronically and comprehensively searched for relevant studies on the diagnostic value of HBV Pre-S1Ag tested by ELISA in patients with hepatitis B virus replication from inception to May 1^st, 2014. Relevant journals were also manually retrieved. Two reviewers independently screened literature according to inclusion and exclusion criteria, extracted data, and assessed methodological quality of included studies. Meta-analysis was then conducted using Meta-Disc 1.4 software. Results Finally, fifteen studies were included, involving 1 994 patients with hepatitis B diagnosed by the gold standard and 526 patients with non-hepatitis B diseases. The results of meta-analysis showed (Sen=0.76, 95%CI 0.74 to 0.78; Spe=0.90, 95%CI 0.88 to 0.91; +LR=8.54, 95%CI 4.25 to 17.15;-LR=0.17, 95%CI 0.10 to 0.27; DOR=65.12, 95%CI 24.91 to 170.28; AUC=0.943 0, SE=0.018 1; Q^*=0.881 3, SE=0.023 4). Conclusion HBV Pre-S1Ag tested by ELISA has certain value in the diagnosis of patients with hepatitis B virus replication. Due to poor methodological quality of the included studies, the above conclusion should be verified by conducting high quality diagnostic tests.

Citation： WANGXiao-cun, TANGJing, WUJun. Value of HBV Pre-S1Ag Tested by Enzyme-linked Immunosorbent Assay in Diagnosis of Hepatitis B Virus Replication: A Meta-Analysis. Chinese Journal of Evidence-Based Medicine, 2014, 14(11): 1318-1325. doi: 10.7507/1672-2531.20140214 Copy

1.	Fattovich G, Bortolotti F, Donato F. Natural history of chronic hepatitis B:Special emphasis on disease progression and prognostic factors. J Hepatol, 2008, 48(2):335-352.
2.	张云娇, 丁明, 张秀玲, 等.广州经济技术开发区外来人群乙型肝炎病毒感染分析.中华医院感染学杂志, 2002, 12(10):763-764.
3.	施理, 刘树人, 孔祥平, 等.免疫接种乙型肝炎病毒外膜小S蛋白产生的细胞免疫反应.中华医院感染学杂志, 2003, 13(8):710-713.
4.	阂福援, 孙桂珍, 王健.前Sl杭原在乙型肝炎诊断及判断预后中的作用.中华检验医学杂志, 2004, 27(4):224-226.
5.	黄启强, 黄丽庆, 周晓兰, 等.乙型肝炎病毒前S1抗原与传统标志物相关性分析.检验医学与临床, 2011, 8(11):1341-1343.
6.	曾钢, 吴斌, 李彩东, 等. 308例慢性乙肝患者血清HBV-DNA载量与肝功能及HBV-M检测结果分析.国际检验医学杂志, 2013, 34(14):1908-1910.
7.	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.
8.	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).中国循证医学杂志, 2007, 7(7):531-536.
9.	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.
10.	Hu KQ, Yu ZQ, Li FH, et al. Expression and clinical significance of pre-S 1 and S2 proteins of HBV in sera of patients with chronic liver disease. Liver, 1989, 9(3):146-152.
11.	van Ditzhuijsen TJM, Kuijpers LPC, Koens MJ, et al. Hepatitis B Pre-S1 and Pre-S2 Proteins:clinical significance and relation to hepatitis B virus DNA. Medical Virology, 1990, 32(2):87-91.
12.	Lian M, Zhou X, Wei L, et al. Serum levels of preS antigen (HBpreSAg) in chronic hepatitis B virus infected patients. Virology Journal, 2007, 4:93.
13.	郑瑾, 昊蓉, 倪振华, 等. HBsAg、抗HBe、抗HBc阳性患者PreSl-Ag与HBV复制的关系研究.检验医学, 2009, 24(12):904-906.
14.	崔红花, 王晶莹, 谢风. HBVPreSl抗原和HBV DNA的监测及临床评价.中国诊断医学, 2007, 11(4):482-485.
15.	毛远丽, 李伯安, 马洪滨, 等.乙肝患者外膜蛋白血清学检测及对于判定HBV DNA复制的意义.中华实验和临床病毒学杂志, 2006, 20(3):276-278.
16.	李琴, 孙桂珍, 魏玉香, 等.前S1蛋白与病毒DNA和核心抗原对乙型肝炎病毒复制诊断的对比.中华肝脏病杂, 2004, 12(3):134-136.
17.	沈洪远, 朱梅英, 陆红兵.前S1抗原在乙型肝炎临床诊断中的意义和应用.华北煤炭医学院学报, 2006, 8(1):31-32.
18.	龚杰, 刘柏林, 方艳秋, 等.乙肝病毒外膜大蛋白、前S1抗原、HBV DNA与血清标志物之间相关性分析.中国实验诊断学, 2013, 17(9):1634-1637.
19.	陈平平.乙型肝炎病毒前S1抗原检测的临床价值.实验与检验医学, 2009, 27(5):507-508.
20.	罗烈伟, 毕燕玲.乙型肝炎病毒前Sl抗原检测的临床应用价值.中国热带医学, 2008, 8(2):220-221.
21.	丁晓琳, 张伦军, 刘蕴霞, 等.乙型肝炎病毒前S1抗原检测在临床中的应用.中华全科医学, 2012, 10(1):109-110.
22.	马红松, 沈忠海, 蒋雁, 等.乙型肝炎病毒前S1抗原与HBV-DNA水平和HBV血清标志物的相关性分析.中华医院感染学志, 2009, 19(17):2248-2249.
23.	尹幼明, 黄景明, 谢服役.乙型肝炎病毒前S1抗原与HBV-M和HBV-DNA及肝功能的相关性分析.中国卫生检验杂志, 2009, 19(6):1361-1362.
24.	吴蓓颖, 蔡刚, 林佳菲, 等.隐匿性乙型肝炎患者乙肝病毒preS/S基因突变分析.中华微生物学和免疫学杂志, 2011, 31(8):724-728.
25.	张菊英, 张亚衡. 920例乙型肝炎患者病毒前S1抗原检测的临床价值探讨.检验医学与临床, 2014, 11(2):247-248.
26.	金鲜花, 齐艳春, 王瑶瑶.乙型肝炎病毒血清前S1抗原的检测及其临床意义.中国误诊学杂志, 2009, 9(16):3857-3858.

1. Fattovich G, Bortolotti F, Donato F. Natural history of chronic hepatitis B:Special emphasis on disease progression and prognostic factors. J Hepatol, 2008, 48(2):335-352.
2. 张云娇, 丁明, 张秀玲, 等.广州经济技术开发区外来人群乙型肝炎病毒感染分析.中华医院感染学杂志, 2002, 12(10):763-764.
3. 施理, 刘树人, 孔祥平, 等.免疫接种乙型肝炎病毒外膜小S蛋白产生的细胞免疫反应.中华医院感染学杂志, 2003, 13(8):710-713.
4. 阂福援, 孙桂珍, 王健.前Sl杭原在乙型肝炎诊断及判断预后中的作用.中华检验医学杂志, 2004, 27(4):224-226.
5. 黄启强, 黄丽庆, 周晓兰, 等.乙型肝炎病毒前S1抗原与传统标志物相关性分析.检验医学与临床, 2011, 8(11):1341-1343.
6. 曾钢, 吴斌, 李彩东, 等. 308例慢性乙肝患者血清HBV-DNA载量与肝功能及HBV-M检测结果分析.国际检验医学杂志, 2013, 34(14):1908-1910.
7. 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.
8. 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).中国循证医学杂志, 2007, 7(7):531-536.
9. 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.
10. Hu KQ, Yu ZQ, Li FH, et al. Expression and clinical significance of pre-S 1 and S2 proteins of HBV in sera of patients with chronic liver disease. Liver, 1989, 9(3):146-152.
11. van Ditzhuijsen TJM, Kuijpers LPC, Koens MJ, et al. Hepatitis B Pre-S1 and Pre-S2 Proteins:clinical significance and relation to hepatitis B virus DNA. Medical Virology, 1990, 32(2):87-91.
12. Lian M, Zhou X, Wei L, et al. Serum levels of preS antigen (HBpreSAg) in chronic hepatitis B virus infected patients. Virology Journal, 2007, 4:93.
13. 郑瑾, 昊蓉, 倪振华, 等. HBsAg、抗HBe、抗HBc阳性患者PreSl-Ag与HBV复制的关系研究.检验医学, 2009, 24(12):904-906.
14. 崔红花, 王晶莹, 谢风. HBVPreSl抗原和HBV DNA的监测及临床评价.中国诊断医学, 2007, 11(4):482-485.
15. 毛远丽, 李伯安, 马洪滨, 等.乙肝患者外膜蛋白血清学检测及对于判定HBV DNA复制的意义.中华实验和临床病毒学杂志, 2006, 20(3):276-278.
16. 李琴, 孙桂珍, 魏玉香, 等.前S1蛋白与病毒DNA和核心抗原对乙型肝炎病毒复制诊断的对比.中华肝脏病杂, 2004, 12(3):134-136.
17. 沈洪远, 朱梅英, 陆红兵.前S1抗原在乙型肝炎临床诊断中的意义和应用.华北煤炭医学院学报, 2006, 8(1):31-32.
18. 龚杰, 刘柏林, 方艳秋, 等.乙肝病毒外膜大蛋白、前S1抗原、HBV DNA与血清标志物之间相关性分析.中国实验诊断学, 2013, 17(9):1634-1637.
19. 陈平平.乙型肝炎病毒前S1抗原检测的临床价值.实验与检验医学, 2009, 27(5):507-508.
20. 罗烈伟, 毕燕玲.乙型肝炎病毒前Sl抗原检测的临床应用价值.中国热带医学, 2008, 8(2):220-221.
21. 丁晓琳, 张伦军, 刘蕴霞, 等.乙型肝炎病毒前S1抗原检测在临床中的应用.中华全科医学, 2012, 10(1):109-110.
22. 马红松, 沈忠海, 蒋雁, 等.乙型肝炎病毒前S1抗原与HBV-DNA水平和HBV血清标志物的相关性分析.中华医院感染学志, 2009, 19(17):2248-2249.
23. 尹幼明, 黄景明, 谢服役.乙型肝炎病毒前S1抗原与HBV-M和HBV-DNA及肝功能的相关性分析.中国卫生检验杂志, 2009, 19(6):1361-1362.
24. 吴蓓颖, 蔡刚, 林佳菲, 等.隐匿性乙型肝炎患者乙肝病毒preS/S基因突变分析.中华微生物学和免疫学杂志, 2011, 31(8):724-728.
25. 张菊英, 张亚衡. 920例乙型肝炎患者病毒前S1抗原检测的临床价值探讨.检验医学与临床, 2014, 11(2):247-248.
26. 金鲜花, 齐艳春, 王瑶瑶.乙型肝炎病毒血清前S1抗原的检测及其临床意义.中国误诊学杂志, 2009, 9(16):3857-3858.

Chinese Journal of Evidence-Based Medicine

Value of HBV Pre-S1Ag Tested by Enzyme-linked Immunosorbent Assay in Diagnosis of Hepatitis B Virus Replication: A Meta-Analysis

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