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.	張云嬌, 丁明, 張秀玲, 等.廣州經濟技術開發區外來人群乙型肝炎病毒感染分析.中華醫院感染學雜志, 2002, 12(10):763-764.
3.	施理, 劉樹人, 孔祥平, 等.免疫接種乙型肝炎病毒外膜小S蛋白產生的細胞免疫反應.中華醫院感染學雜志, 2003, 13(8):710-713.
4.	閡福援, 孫桂珍, 王健.前Sl杭原在乙型肝炎診斷及判斷預后中的作用.中華檢驗醫學雜志, 2004, 27(4):224-226.
5.	黃啟強, 黃麗慶, 周曉蘭, 等.乙型肝炎病毒前S1抗原與傳統標志物相關性分析.檢驗醫學與臨床, 2011, 8(11):1341-1343.
6.	曾鋼, 吳斌, 李彩東, 等. 308例慢性乙肝患者血清HBV-DNA載量與肝功能及HBV-M檢測結果分析.國際檢驗醫學雜志, 2013, 34(14):1908-1910.
7.	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.
8.	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).中國循證醫學雜志, 2007, 7(7):531-536.
9.	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):97-108.
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.	鄭瑾, 昊蓉, 倪振華, 等. HBsAg、抗HBe、抗HBc陽性患者PreSl-Ag與HBV復制的關系研究.檢驗醫學, 2009, 24(12):904-906.
14.	崔紅花, 王晶瑩, 謝風. HBVPreSl抗原和HBV DNA的監測及臨床評價.中國診斷醫學, 2007, 11(4):482-485.
15.	毛遠麗, 李伯安, 馬洪濱, 等.乙肝患者外膜蛋白血清學檢測及對于判定HBV DNA復制的意義.中華實驗和臨床病毒學雜志, 2006, 20(3):276-278.
16.	李琴, 孫桂珍, 魏玉香, 等.前S1蛋白與病毒DNA和核心抗原對乙型肝炎病毒復制診斷的對比.中華肝臟病雜, 2004, 12(3):134-136.
17.	沈洪遠, 朱梅英, 陸紅兵.前S1抗原在乙型肝炎臨床診斷中的意義和應用.華北煤炭醫學院學報, 2006, 8(1):31-32.
18.	龔杰, 劉柏林, 方艷秋, 等.乙肝病毒外膜大蛋白、前S1抗原、HBV DNA與血清標志物之間相關性分析.中國實驗診斷學, 2013, 17(9):1634-1637.
19.	陳平平.乙型肝炎病毒前S1抗原檢測的臨床價值.實驗與檢驗醫學, 2009, 27(5):507-508.
20.	羅烈偉, 畢燕玲.乙型肝炎病毒前Sl抗原檢測的臨床應用價值.中國熱帶醫學, 2008, 8(2):220-221.
21.	丁曉琳, 張倫軍, 劉蘊霞, 等.乙型肝炎病毒前S1抗原檢測在臨床中的應用.中華全科醫學, 2012, 10(1):109-110.
22.	馬紅松, 沈忠海, 蔣雁, 等.乙型肝炎病毒前S1抗原與HBV-DNA水平和HBV血清標志物的相關性分析.中華醫院感染學志, 2009, 19(17):2248-2249.
23.	尹幼明, 黃景明, 謝服役.乙型肝炎病毒前S1抗原與HBV-M和HBV-DNA及肝功能的相關性分析.中國衛生檢驗雜志, 2009, 19(6):1361-1362.
24.	吳蓓穎, 蔡剛, 林佳菲, 等.隱匿性乙型肝炎患者乙肝病毒preS/S基因突變分析.中華微生物學和免疫學雜志, 2011, 31(8):724-728.
25.	張菊英, 張亞衡. 920例乙型肝炎患者病毒前S1抗原檢測的臨床價值探討.檢驗醫學與臨床, 2014, 11(2):247-248.
26.	金鮮花, 齊艷春, 王瑤瑤.乙型肝炎病毒血清前S1抗原的檢測及其臨床意義.中國誤診學雜志, 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. 張云嬌, 丁明, 張秀玲, 等.廣州經濟技術開發區外來人群乙型肝炎病毒感染分析.中華醫院感染學雜志, 2002, 12(10):763-764.
3. 施理, 劉樹人, 孔祥平, 等.免疫接種乙型肝炎病毒外膜小S蛋白產生的細胞免疫反應.中華醫院感染學雜志, 2003, 13(8):710-713.
4. 閡福援, 孫桂珍, 王健.前Sl杭原在乙型肝炎診斷及判斷預后中的作用.中華檢驗醫學雜志, 2004, 27(4):224-226.
5. 黃啟強, 黃麗慶, 周曉蘭, 等.乙型肝炎病毒前S1抗原與傳統標志物相關性分析.檢驗醫學與臨床, 2011, 8(11):1341-1343.
6. 曾鋼, 吳斌, 李彩東, 等. 308例慢性乙肝患者血清HBV-DNA載量與肝功能及HBV-M檢測結果分析.國際檢驗醫學雜志, 2013, 34(14):1908-1910.
7. 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.
8. 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).中國循證醫學雜志, 2007, 7(7):531-536.
9. 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):97-108.
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. 鄭瑾, 昊蓉, 倪振華, 等. HBsAg、抗HBe、抗HBc陽性患者PreSl-Ag與HBV復制的關系研究.檢驗醫學, 2009, 24(12):904-906.
14. 崔紅花, 王晶瑩, 謝風. HBVPreSl抗原和HBV DNA的監測及臨床評價.中國診斷醫學, 2007, 11(4):482-485.
15. 毛遠麗, 李伯安, 馬洪濱, 等.乙肝患者外膜蛋白血清學檢測及對于判定HBV DNA復制的意義.中華實驗和臨床病毒學雜志, 2006, 20(3):276-278.
16. 李琴, 孫桂珍, 魏玉香, 等.前S1蛋白與病毒DNA和核心抗原對乙型肝炎病毒復制診斷的對比.中華肝臟病雜, 2004, 12(3):134-136.
17. 沈洪遠, 朱梅英, 陸紅兵.前S1抗原在乙型肝炎臨床診斷中的意義和應用.華北煤炭醫學院學報, 2006, 8(1):31-32.
18. 龔杰, 劉柏林, 方艷秋, 等.乙肝病毒外膜大蛋白、前S1抗原、HBV DNA與血清標志物之間相關性分析.中國實驗診斷學, 2013, 17(9):1634-1637.
19. 陳平平.乙型肝炎病毒前S1抗原檢測的臨床價值.實驗與檢驗醫學, 2009, 27(5):507-508.
20. 羅烈偉, 畢燕玲.乙型肝炎病毒前Sl抗原檢測的臨床應用價值.中國熱帶醫學, 2008, 8(2):220-221.
21. 丁曉琳, 張倫軍, 劉蘊霞, 等.乙型肝炎病毒前S1抗原檢測在臨床中的應用.中華全科醫學, 2012, 10(1):109-110.
22. 馬紅松, 沈忠海, 蔣雁, 等.乙型肝炎病毒前S1抗原與HBV-DNA水平和HBV血清標志物的相關性分析.中華醫院感染學志, 2009, 19(17):2248-2249.
23. 尹幼明, 黃景明, 謝服役.乙型肝炎病毒前S1抗原與HBV-M和HBV-DNA及肝功能的相關性分析.中國衛生檢驗雜志, 2009, 19(6):1361-1362.
24. 吳蓓穎, 蔡剛, 林佳菲, 等.隱匿性乙型肝炎患者乙肝病毒preS/S基因突變分析.中華微生物學和免疫學雜志, 2011, 31(8):724-728.
25. 張菊英, 張亞衡. 920例乙型肝炎患者病毒前S1抗原檢測的臨床價值探討.檢驗醫學與臨床, 2014, 11(2):247-248.
26. 金鮮花, 齊艷春, 王瑤瑤.乙型肝炎病毒血清前S1抗原的檢測及其臨床意義.中國誤診學雜志, 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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