前S1抗原检测在献血人群的HBV感染筛查中的应用
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摘要
目的:通过比较献血人群中谷丙转氨酶、乙肝表面抗原和前S1抗原检测与HBV-DNA检测结果的一致性,探讨前S1抗原检测在献血人群中筛查乙肝病毒感染者的应用价值。方法:1080份献血样本中,采用ELISA法检测前S1抗原,PCR法检测HBV-DNA,分析前S1抗原检测与HBV-DNA检测的一致性。结果:(1)1000例合格的献血人群中,前S1抗原的阳性率为0.3%,HBV-DNA阳性率为0.1%,两者呈中度一致性(Kappa值=0.499),且有统计学意义(P<0.05)。(2)1080例样本中,ALT、HBs Ag、前S1抗原的阳性率分别为5.83%、1.76%、1.67%,HBV-DNA阳性率为0.93%,ALT检测法与HBV-DNA检测无一致性(Kappa值=-0.0162);HBs Ag检测与HBV-DNA检测呈高度一致性(Kappa值=0.6160),前S1抗原检测与HBV-DNA检测呈高度一致性(Kappa值=0.7108),二者均有统计学意义(P<0.05)。(3)ALT和HBs Ag两项联合检测及ALT、HBs Ag和前S1抗原三项联合检测的阳性率分别为7.41%、7.69%,HBV-DNA阳性率为0.93%。两项联合检测法与HBV-DNA检验结果一致(Kappa值=0.1866),三项联合检测法与HBV-DNA检验结果一致(Kappa值=0.2019),均有统计学意义(P<0.05)。结论:前S1抗原检测与HBV-DNA检测有较高一致性,能够减少献血人群中HBV感染的漏检;将ALT、HBs Ag和前S1抗原进行联合检测能够提高HBV感染筛查率。
Objective: To investigate the value of determining Pre-S1 antigen in screening blood donators with HBV infection by comparing the consistency between ALT, HBs Ag, Pre-S1 antigen tests and HBV-DNA tests for blood donators. Methods: A total of 1080 samples were respectively tested by Pre-S1 antigen with an ELISA method and HBV-DNA with a PCR method. Based on the results of tests, the consistency between Pre-S1 antigen and HBV-DNA tests was analyzed. Results:(1) In 1000 cases of qualified samples, the positive rate of Pre-S1 antigen was 0.3%, and the positive rate of HBV-DNA was 0.1%, these two test indexes had a medium-degree consistency(Kappa value 0.499)(P<0.05).(2)In 1080 cases of blood samples, the positive rates of ALT, HBs Ag and Pre-S1 antigen were5.83%,1.76% and 1.67%, and the positive rate of HBV-DNA was 0.93%. There was no statistical difference in the positive rate of HBs Ag and Pre-S1 antigen but ALT respectively compared that of HBV-DNA(P>0.05). There were statistical difference for the positive rate of ALT, HBs Ag and Pre-S1 antigen respectively compared that of HBV-DNA(P< 0.05). Kappa's test showed no consistency between ALT and HBV-DNA(Kappa value-0.0162), high-degree consistency between HBs Ag and HBV-DNA(Kappa value 0.6160)and high-degree consistency between Pre-S1 antigen and HBV-DNA(Kappa value 0.7108) were found(P<0.05).(3)In 1080 cases of blood samples, the positive rate of combined ALT and HBs Ag was 7.41%, the positive rate of combined ALT plus HBs Ag plus Pre-S1 antigen was 7.69%, and the positive rate of HBV-DNA was 0.93%. There were statistical difference in the positive rates of the combined with Pre-S1 antigen and without Pre-S1 antigen respectively compared that of HBV-DNA(P<0.05). Kappa's test showed consistency between combined ALT plus HBs Ag and HBV-DNA with a Kappa value of 0.1866, as well as a consistency between combined ALT plus HBs Ag plus Pre-S1 antigen and HBV-DNA with a Kappa value of 0.2019(P<0.05). Conclusions: The test of Pre-S1 antigen had a superior consistency with test of HBV-DNA, and could be used to screen the untested donated blood samples with HBV. Furthermore, a combined test of Pre-S1 antigen, ALT and HBs Ag could increase the screening rates of donated blood samples with HBV.
Objective: To investigate the value of determining Pre-S1 antigen in screening blood donators with HBV infection by comparing the consistency between ALT, HBs Ag, Pre-S1 antigen tests and HBV-DNA tests for blood donators. Methods: A total of 1080 samples were respectively tested by Pre-S1 antigen with an ELISA method and HBV-DNA with a PCR method. Based on the results of tests, the consistency between Pre-S1 antigen and HBV-DNA tests was analyzed. Results:(1) In 1000 cases of qualified samples, the positive rate of Pre-S1 antigen was 0.3%, and the positive rate of HBV-DNA was 0.1%, these two test indexes had a medium-degree consistency(Kappa value 0.499)(P<0.05).(2)In 1080 cases of blood samples, the positive rates of ALT, HBs Ag and Pre-S1 antigen were5.83%,1.76% and 1.67%, and the positive rate of HBV-DNA was 0.93%. There was no statistical difference in the positive rate of HBs Ag and Pre-S1 antigen but ALT respectively compared that of HBV-DNA(P>0.05). There were statistical difference for the positive rate of ALT, HBs Ag and Pre-S1 antigen respectively compared that of HBV-DNA(P< 0.05). Kappa's test showed no consistency between ALT and HBV-DNA(Kappa value-0.0162), high-degree consistency between HBs Ag and HBV-DNA(Kappa value 0.6160)and high-degree consistency between Pre-S1 antigen and HBV-DNA(Kappa value 0.7108) were found(P<0.05).(3)In 1080 cases of blood samples, the positive rate of combined ALT and HBs Ag was 7.41%, the positive rate of combined ALT plus HBs Ag plus Pre-S1 antigen was 7.69%, and the positive rate of HBV-DNA was 0.93%. There were statistical difference in the positive rates of the combined with Pre-S1 antigen and without Pre-S1 antigen respectively compared that of HBV-DNA(P<0.05). Kappa's test showed consistency between combined ALT plus HBs Ag and HBV-DNA with a Kappa value of 0.1866, as well as a consistency between combined ALT plus HBs Ag plus Pre-S1 antigen and HBV-DNA with a Kappa value of 0.2019(P<0.05). Conclusions: The test of Pre-S1 antigen had a superior consistency with test of HBV-DNA, and could be used to screen the untested donated blood samples with HBV. Furthermore, a combined test of Pre-S1 antigen, ALT and HBs Ag could increase the screening rates of donated blood samples with HBV.
引文
[1]毛佳,王锦秀,王艳,等.检测乙型肝炎病毒前S1抗原的临床价值[J].中华实验和临床病毒学杂志,2014,28(6):455-457Mao Jia,Wang Jin-xiu,Wang Yan,et al.Significance of detection of HBV pre-S1 antigen[J].Chinese Journal of Experimental and Clinical Virology,2014,28(6):455-457
[2]李彩东,吴斌,陈锡莲,等.乙型肝炎病毒前S1抗原与HBV-DNA和HBV-M及肝功能的相关性探讨[J].国际检验医学杂志,2015,36(7):936-938Li Cai-dong,Wu Bin,Chen Xi-lian,et al.Study on correlation between HBV Pre-S1 antigen with HBV-DNA,HBV M and liver function in patients with hepatitis B[J].International Journal of Laboratory Medicine,2015,36(7):936-938
[3]Nna E,Mbamalu C,Ekejindu I,et al.Occult hepatiais B viral infection among blood donors in South-Eastern Nigeria[J].Pathog Glob Health,2014,108(5):223-228
[4]Stolz M,Tinguely C,Fontana S,et al.Hepatitits B virus DNA viral load determination in hepatitis B surface antigen-negative Swiss blood donors[J].Transfusion,2014,54(11):2961-2967
[5]Lieshout-krikke Rw,Molenaar-de Backer Mw,Van Swieten P,et al.Surface antigen-negative hepatitis B virus infection in Dutch blood donors[J].Eur J Clin Micorbiol Infect Dis,2014,33(1):69-77
[6]伍晓菲,刘晓颖,张博,等.HBs Ag阴性、HBV DNA阳性献血者病毒感染特征研究[J].临床输血与检验,2014,16(3):232-236Wu Xiao-fei,Liu Xiao-ying,Zhang Bo,et al.Characteristic of HBs Ag-negative with HBV DNA-positive in blood donors[J].Journal of Clinical Transfusion and Laboratory Medicine,2014,16(3):232-236
[7]Kim BK,Choi SH,Ahn SH,et al.Pre-S mutations of hepatitis B virus affect genome replication and expression of surface antigens[J].Gastroenterol Hepatol,2014,29(4):843-850
[8]Wang B,Feng Y,Li Z,et al.Distribution and diversity of hepatitis B virus genotypes in Yunnan,China[J].J Med Virol,2014,86(10):1675-1682
[9]曹树正,王文武.乙型肝炎表面抗原ELISA检测假阴性样本的分析[J].现代检验医学,2012,27(1):9-10Cao Shu-zheng,Wang Wen-wu.Analyses of Samples for False Negative HBs Ag with ELISA Assay[J].Journal of Modern Laboratory Medicine,2012,27(1):9-10
[10]王元,朱亚洲,种莹,等.乙肝患者血清的HBV-DNA含量与ALT水平的关系研究[J].现代生物医学进展,2014,14(29):5735-5737+5746Wang Yuan,Zhu Ya-zhou,Zhong Ying,et al.Research of the Relationship Between Serum HBV-DNA Content and ALT Level in Hepatitis B Patients[J].Progress in Modern Biomedicine,2014,14(29):5735-5737+5746
[11]赖菁,淦伟强,谢冬英,等.不同HBe Ag状态慢加急性肝衰竭患者临终前HBV-DNA载量的动态分析[J].中华肝脏病杂志,2012,20(7):522-525Lai Jing,Gan Wei-qiang,Xie Dong-ying,et al.Dynamics of serum HBV DNA levels during the terminal phases of acute-on-chronic hepatitis B liver failure with different HBe Ag status[J].Chinese Journal of Hepatology,2012,20(7):522-525
[12]刘顺庆,朱晓骏,孙学华,等.ALT轻度升高的HBe Ag阳性和阴性慢性乙型肝炎患者肝组织病理学特点[J].中华肝脏病杂志,2012,20(7):348-352Liu Shun-qing,Zhu Xiao-jun,Sun Xue-hua,et al.Characterstic of liver pathology in HBe Ag-positive and HBe Ag-negative chronic hepatitis B patients with midly elevated ALT[J].Chinese Journal of Hepaology,2012,20(7):348-352
[13]董勤敏,王静,胡媛,等.献血中非病理性ALT增高的原因分析[J].中国卫生标准管理,2015,6(21):144-145Dong Qin-min,Wang Jing,Hu Yuan,et al.Analysis of the Reasons for the Increased ALT in Blood Donation[J].China Health Standard Management,2015,6(21):144-145
[14]孙桂香,薛英娜,吕颖,等.提高筛选献血员ALT标准对献血员初复检合格率的影响[J].标记免疫分析与临床,2015,22(6):481-482+498Sun Gui-xiang,Xue Ying-na,Lv Ying,et al.Study on the Impact of Raising of ALT Thresholds for Blood Donors on the Pass Rates of Initial-examination and Re-examination[J].Labeled Immunoassays and Clinical Medicine,2015,22(6):481-482+498
[15]苏秋东,郭敏卓,伊瑶,等.两种嵌合乙型肝炎病毒pre-S1中和表位的乙肝核心病毒样颗粒的制备与抗原性分析[J].中华实验和临床病毒学杂志,2013,27(5):336-339Su Qiu-dong,Guo Min-zhuo,Yi Yao,et al.Antigenic analysis of two chimeric hepatitis B core particles presenting the pre-Sl neutralizing epitopes[J].Chinese Journal of Experimental and Clinical Virology,2013,27(5):336-339
[16]王慧玲.乙肝病毒前S1抗原与HBe Ag及HBV-DNA之间的相关分析[J].内蒙古医学杂志,2012,44(5):529-531Wang Hui-ling.Correlation Between Pre Sl-Ag,HBe Ag and HBV-DNA in the Serum of Chronic Hepatitis B Patients[J].Inner Mongolia Medical Journal,2012,44(5):529-531
[17]Chi SW,Kim DH,Lee SH,et al.Pre-structured motifs in the natively unstructured pre S1 surface antigen of hepatitis B virus[J].Protein Sci,2007,16(10):2108-2117
[18]黄艳萍,祝峰,王新元,等.乙型肝炎前S1,S2抗原与HBV-DNA的相关性分析[J].武警医学,2015,26(6):600-602Huang Yan-ping,Zhu Feng,Wang Xin-yuan,et al.Relationship between hepatitis B virus former S1 antigen,former S2 antigen,and HBV-DNA,and their clinical significance[J].Medical Journal of the Chinese People's Armed Police Forces,2015,26(6):600-602
[19]周珣,李浩,吴皖,等.乙型肝炎病毒前S1抗原检测的临床价值分析[J].湖北师范大学学报(医学版),2015,16(2):60-62Zhou Xun,Li Hao,Wu Wan,et al.The clinical value of pre-S1antigen in the detection of hepatitis B virus[J].Journal of Hunan Normal University(Medicial Science),2015,16(2):60-62
[20]刘波,王君,邱小华.乙型肝炎病毒前S1抗原与其血清标志物及DNA的关系分析[J].国际流行病学传染病学杂志,2011,38(5):308-310Liu Bo,Wang Jun,Qiu Xiao-hua.Relations between HBV Pre-S1antigen and its serological markers and HBV DNA[J].International Journal of Epidemiology and Infectious Disease,2011,38(5):308-310
[2]李彩东,吴斌,陈锡莲,等.乙型肝炎病毒前S1抗原与HBV-DNA和HBV-M及肝功能的相关性探讨[J].国际检验医学杂志,2015,36(7):936-938Li Cai-dong,Wu Bin,Chen Xi-lian,et al.Study on correlation between HBV Pre-S1 antigen with HBV-DNA,HBV M and liver function in patients with hepatitis B[J].International Journal of Laboratory Medicine,2015,36(7):936-938
[3]Nna E,Mbamalu C,Ekejindu I,et al.Occult hepatiais B viral infection among blood donors in South-Eastern Nigeria[J].Pathog Glob Health,2014,108(5):223-228
[4]Stolz M,Tinguely C,Fontana S,et al.Hepatitits B virus DNA viral load determination in hepatitis B surface antigen-negative Swiss blood donors[J].Transfusion,2014,54(11):2961-2967
[5]Lieshout-krikke Rw,Molenaar-de Backer Mw,Van Swieten P,et al.Surface antigen-negative hepatitis B virus infection in Dutch blood donors[J].Eur J Clin Micorbiol Infect Dis,2014,33(1):69-77
[6]伍晓菲,刘晓颖,张博,等.HBs Ag阴性、HBV DNA阳性献血者病毒感染特征研究[J].临床输血与检验,2014,16(3):232-236Wu Xiao-fei,Liu Xiao-ying,Zhang Bo,et al.Characteristic of HBs Ag-negative with HBV DNA-positive in blood donors[J].Journal of Clinical Transfusion and Laboratory Medicine,2014,16(3):232-236
[7]Kim BK,Choi SH,Ahn SH,et al.Pre-S mutations of hepatitis B virus affect genome replication and expression of surface antigens[J].Gastroenterol Hepatol,2014,29(4):843-850
[8]Wang B,Feng Y,Li Z,et al.Distribution and diversity of hepatitis B virus genotypes in Yunnan,China[J].J Med Virol,2014,86(10):1675-1682
[9]曹树正,王文武.乙型肝炎表面抗原ELISA检测假阴性样本的分析[J].现代检验医学,2012,27(1):9-10Cao Shu-zheng,Wang Wen-wu.Analyses of Samples for False Negative HBs Ag with ELISA Assay[J].Journal of Modern Laboratory Medicine,2012,27(1):9-10
[10]王元,朱亚洲,种莹,等.乙肝患者血清的HBV-DNA含量与ALT水平的关系研究[J].现代生物医学进展,2014,14(29):5735-5737+5746Wang Yuan,Zhu Ya-zhou,Zhong Ying,et al.Research of the Relationship Between Serum HBV-DNA Content and ALT Level in Hepatitis B Patients[J].Progress in Modern Biomedicine,2014,14(29):5735-5737+5746
[11]赖菁,淦伟强,谢冬英,等.不同HBe Ag状态慢加急性肝衰竭患者临终前HBV-DNA载量的动态分析[J].中华肝脏病杂志,2012,20(7):522-525Lai Jing,Gan Wei-qiang,Xie Dong-ying,et al.Dynamics of serum HBV DNA levels during the terminal phases of acute-on-chronic hepatitis B liver failure with different HBe Ag status[J].Chinese Journal of Hepatology,2012,20(7):522-525
[12]刘顺庆,朱晓骏,孙学华,等.ALT轻度升高的HBe Ag阳性和阴性慢性乙型肝炎患者肝组织病理学特点[J].中华肝脏病杂志,2012,20(7):348-352Liu Shun-qing,Zhu Xiao-jun,Sun Xue-hua,et al.Characterstic of liver pathology in HBe Ag-positive and HBe Ag-negative chronic hepatitis B patients with midly elevated ALT[J].Chinese Journal of Hepaology,2012,20(7):348-352
[13]董勤敏,王静,胡媛,等.献血中非病理性ALT增高的原因分析[J].中国卫生标准管理,2015,6(21):144-145Dong Qin-min,Wang Jing,Hu Yuan,et al.Analysis of the Reasons for the Increased ALT in Blood Donation[J].China Health Standard Management,2015,6(21):144-145
[14]孙桂香,薛英娜,吕颖,等.提高筛选献血员ALT标准对献血员初复检合格率的影响[J].标记免疫分析与临床,2015,22(6):481-482+498Sun Gui-xiang,Xue Ying-na,Lv Ying,et al.Study on the Impact of Raising of ALT Thresholds for Blood Donors on the Pass Rates of Initial-examination and Re-examination[J].Labeled Immunoassays and Clinical Medicine,2015,22(6):481-482+498
[15]苏秋东,郭敏卓,伊瑶,等.两种嵌合乙型肝炎病毒pre-S1中和表位的乙肝核心病毒样颗粒的制备与抗原性分析[J].中华实验和临床病毒学杂志,2013,27(5):336-339Su Qiu-dong,Guo Min-zhuo,Yi Yao,et al.Antigenic analysis of two chimeric hepatitis B core particles presenting the pre-Sl neutralizing epitopes[J].Chinese Journal of Experimental and Clinical Virology,2013,27(5):336-339
[16]王慧玲.乙肝病毒前S1抗原与HBe Ag及HBV-DNA之间的相关分析[J].内蒙古医学杂志,2012,44(5):529-531Wang Hui-ling.Correlation Between Pre Sl-Ag,HBe Ag and HBV-DNA in the Serum of Chronic Hepatitis B Patients[J].Inner Mongolia Medical Journal,2012,44(5):529-531
[17]Chi SW,Kim DH,Lee SH,et al.Pre-structured motifs in the natively unstructured pre S1 surface antigen of hepatitis B virus[J].Protein Sci,2007,16(10):2108-2117
[18]黄艳萍,祝峰,王新元,等.乙型肝炎前S1,S2抗原与HBV-DNA的相关性分析[J].武警医学,2015,26(6):600-602Huang Yan-ping,Zhu Feng,Wang Xin-yuan,et al.Relationship between hepatitis B virus former S1 antigen,former S2 antigen,and HBV-DNA,and their clinical significance[J].Medical Journal of the Chinese People's Armed Police Forces,2015,26(6):600-602
[19]周珣,李浩,吴皖,等.乙型肝炎病毒前S1抗原检测的临床价值分析[J].湖北师范大学学报(医学版),2015,16(2):60-62Zhou Xun,Li Hao,Wu Wan,et al.The clinical value of pre-S1antigen in the detection of hepatitis B virus[J].Journal of Hunan Normal University(Medicial Science),2015,16(2):60-62
[20]刘波,王君,邱小华.乙型肝炎病毒前S1抗原与其血清标志物及DNA的关系分析[J].国际流行病学传染病学杂志,2011,38(5):308-310Liu Bo,Wang Jun,Qiu Xiao-hua.Relations between HBV Pre-S1antigen and its serological markers and HBV DNA[J].International Journal of Epidemiology and Infectious Disease,2011,38(5):308-310