不同方法学测定乙型肝炎病毒核心抗体的阳性率及其定量检测意义的研究
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摘要
目的对比分析不同方法学检测乙型肝炎病毒核心抗体(anti-HBc)的阳性率并探讨其定量检测的意义。方法临床随机收集健康查体者的标本400例,使用化学发光法和酶联免疫吸附测定法的anti-HBc试剂盒进行检测,对比分析其检测anti-HBc的阳性率。另外,对97例临床慢性乙型病毒性肝炎(chronic hepatitis B,CHB)患者跟踪随访,收集其药物治疗前后的血清标本并检测anti-HBc浓度,根据治疗前anti-HBc的浓度水平分成高低浓度两组,分析评价抗病毒治疗后不同浓度anti-HBc分组间患者乙型肝炎病毒e抗原(hepatitis B virus e antigen,HBeAg)的浓度变化。结果化学发光法的两种anti-HBc试剂盒检测健康查体者的anti-HBc的阳性率均为42.0%;酶联免疫吸附测定法anti-HBc检测试剂盒检测健康查体者标本,1∶30稀释后anti-HBc的阳性率为15.0%,原倍检测anti-HBc的阳性率为79.0%。高浓度组(≥9 000 IU/mL)治疗后HBeAg转阴率为20.83%;anti-HBc低浓度组(<9 000 IU/mL)治疗后HBeAg转阴率为2.04%。经卡方检验,anti-HBc高浓度组HBeAg转阴率比anti-HBc低浓度组HBeAg转阴率明显增高,差异具有统计学意义(P<0.05)。结论化学发光法测定anti-HBc的性能优于酶联免疫吸附测定法,可降低酶联免疫吸附测定法测定不稀释标本时的假阳性率和测定稀释标本时的漏检率。通过测定anti HBc的浓度水平,可预测慢性乙肝患者进行药物治疗的效果。
Objective To analyze the positive rate of anti-HBc detected by using different methodologies and to study on its quantitative detection significance. Methods 400 normal samples and 194 pre-and post-treatment serum specimens from 97 patients with chronic hepatitis B infection(CHB) were collected randomly, measured by chemiluminescence immunoassay(CLIA) and enzyme-linked immunosorbent assay(ELISA) anti-HBc detection kits, and the anti-HBc positive rate was analyzed statistically. Then, according to the baseline of anti-HBc titers, CHB patients were divided into high and low concentration groups, and the Hbe Ag seroconversion was examined in post-treatment patients receiving antiviral drug treatment. Results The antiHBc positive rate of healthy individuals was 42.0% measured by chemiluminescence immunoassay from two anti-HBc kits, and it was 15.0% and 79.0% measured by ELISA kit from following 1∶30 dilution and without dilution respectively. The HBeAg seroconversion rates were 20.83% and 2.04% in the patients with high base-line anti-HBc titers(≥9 000 IU/mL) and low baseline anti-HBc titers(<9 000 IU/mL) respectively. According to Chi-square test, the HBeAg seroconversion rates were significantly different between the 2 groups(P<0.05).Conclusion The anti-HBc positive rate of healthy individuals measured by chemiluminescence immunoassay anti-HBc kits, was lower than that of undiluted samples by ELISA, and the diluted specimens had great influence on the measure of anti-HBc positive rate by ELISA. The CHB patients with high baseline anti-HBc titers(≥9 000 IU/mL) had a greater HBeAg seroconversion rate than those with low baseline anti-HBc titers(<9 000 IU/mL).
Objective To analyze the positive rate of anti-HBc detected by using different methodologies and to study on its quantitative detection significance. Methods 400 normal samples and 194 pre-and post-treatment serum specimens from 97 patients with chronic hepatitis B infection(CHB) were collected randomly, measured by chemiluminescence immunoassay(CLIA) and enzyme-linked immunosorbent assay(ELISA) anti-HBc detection kits, and the anti-HBc positive rate was analyzed statistically. Then, according to the baseline of anti-HBc titers, CHB patients were divided into high and low concentration groups, and the Hbe Ag seroconversion was examined in post-treatment patients receiving antiviral drug treatment. Results The antiHBc positive rate of healthy individuals was 42.0% measured by chemiluminescence immunoassay from two anti-HBc kits, and it was 15.0% and 79.0% measured by ELISA kit from following 1∶30 dilution and without dilution respectively. The HBeAg seroconversion rates were 20.83% and 2.04% in the patients with high base-line anti-HBc titers(≥9 000 IU/mL) and low baseline anti-HBc titers(<9 000 IU/mL) respectively. According to Chi-square test, the HBeAg seroconversion rates were significantly different between the 2 groups(P<0.05).Conclusion The anti-HBc positive rate of healthy individuals measured by chemiluminescence immunoassay anti-HBc kits, was lower than that of undiluted samples by ELISA, and the diluted specimens had great influence on the measure of anti-HBc positive rate by ELISA. The CHB patients with high baseline anti-HBc titers(≥9 000 IU/mL) had a greater HBeAg seroconversion rate than those with low baseline anti-HBc titers(<9 000 IU/mL).
引文
[1]袁权.隐匿性HBV感染中的HBs Ag变异株研究及Anti-HBc定量水平的临床新意义探索[D].厦门:厦门大学,2012.
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[9]张晓琍,王金龙,林光华,等.免疫人群乙肝抗体阳性率调查及乙肝核心抗体检测方法探讨[J].中国人兽共患病学报,2015,31(3):289-292.
[10]陆盈.单项乙型肝炎病毒核心抗体阳性的原因及其临床意义[J].海南医学,2013,24(11):1636-1638.
[11]汪咏新,刘军.乙型肝炎病毒核心抗体原倍血清与不同稀释比例对实验结果的影响[J].医学检验与临床,2008,19(4):53-54.
[12]李金明.乙型肝炎病毒血清标志物测定及结果解释的若干问题[J].中华检验医学杂志,2006,29(5):385-389.
[13]中华医学会肝病学分会.慢性乙型肝炎防治指南(2015年版)[J].中国肝脏病杂志:电子版,2015,19(5):1-19.
[14]袁权,宋浏伟,周文彬,等.Anti-HBc定量检测方法及其在监控慢性乙肝患者病情发展和预测治疗疗效中的用途:中国,103217533[P].2013-07-24.
[15]Fan R,Sun J,Yuan Q,et al.Baseline quantitative hepatitis B core antibody titre alone strongly predicts HBe Ag seroconversion across chronic hepatitis B patients treated with peginterferon or nucleos(t)ide analogues[J].Gut,2016,65(2):313-320.
[16]Yuan Q,Song LW,Cavallone D,et al.Total hepatitis B core antigen antibody,a quantitative non-invasive marker of hepatitis B virus induced liver disease[J].PLo S One,2015,26,10(6):e0130209.
[2]张碧莹,邢延芳,王珍珠,等.血清稀释与否对检测乙型肝炎核心抗体结果的影响[J].中国实验诊断学,2014,18(3):428-430.
[3]范殿英,于素芳,韩风文等.乙型肝炎核心抗体在正常人群中的分布及其传染源作用[J].天津医药,1985(6):331-334.
[4]张晓琍,王金龙,林光华等.免疫人群乙肝抗体阳性率调查及乙肝核心抗体检测方法探讨[J].中国人兽共患病学报,2015,31(3):289-292.
[5]Hui CK,Leung N,Shek TW,et al.Sustained disease remission after spontaneous HBe Ag seroconversion is associated with reduction in fibrosis progression in chronic hepatitis B Chinese patients.Hepatology,2007,46:690-698.
[6]陈冲,张毅,卓其斌,等.乙型肝炎核心抗体定量检测的研究进展[J].肝脏,2016,21(9):781-784.
[7]何宗忠,裘宇容.乙型肝炎病毒生物标志物检测的研究进展[J].分子诊断与治疗杂志,2009,1(2):135-140.
[8]马海芳.1783例乙型肝炎病毒血清学标志物检测结果分析[J].医学综述,2010,16(22):3516-3517.
[9]张晓琍,王金龙,林光华,等.免疫人群乙肝抗体阳性率调查及乙肝核心抗体检测方法探讨[J].中国人兽共患病学报,2015,31(3):289-292.
[10]陆盈.单项乙型肝炎病毒核心抗体阳性的原因及其临床意义[J].海南医学,2013,24(11):1636-1638.
[11]汪咏新,刘军.乙型肝炎病毒核心抗体原倍血清与不同稀释比例对实验结果的影响[J].医学检验与临床,2008,19(4):53-54.
[12]李金明.乙型肝炎病毒血清标志物测定及结果解释的若干问题[J].中华检验医学杂志,2006,29(5):385-389.
[13]中华医学会肝病学分会.慢性乙型肝炎防治指南(2015年版)[J].中国肝脏病杂志:电子版,2015,19(5):1-19.
[14]袁权,宋浏伟,周文彬,等.Anti-HBc定量检测方法及其在监控慢性乙肝患者病情发展和预测治疗疗效中的用途:中国,103217533[P].2013-07-24.
[15]Fan R,Sun J,Yuan Q,et al.Baseline quantitative hepatitis B core antibody titre alone strongly predicts HBe Ag seroconversion across chronic hepatitis B patients treated with peginterferon or nucleos(t)ide analogues[J].Gut,2016,65(2):313-320.
[16]Yuan Q,Song LW,Cavallone D,et al.Total hepatitis B core antigen antibody,a quantitative non-invasive marker of hepatitis B virus induced liver disease[J].PLo S One,2015,26,10(6):e0130209.