采用高敏检测技术检测血清HBV DNA载量筛选低病毒血症的无偿献血人群隐匿性乙型肝炎病毒感染研究*

doi:10.3969/j.issn.1672-5069.2023.02.005

摘要/Abstract

摘要： 目的探讨采用高敏检测技术检测血清乙型肝炎病毒(HBV)DNA筛选低病毒血症(LLV)的无偿献血人群隐匿性乙型肝炎病毒感染(OBI)的价值。方法 2017年2月～2021年12月我市收集的11352份血清HBsAg阴性的无偿献血人群血液标本,采用电化学发光法定性检测血清HBeAg、HBeAb和HBcAb),定量检测血清HBsAb,使用AU5800型全自动生化分析仪检测血生化指标,使用ABI ViiA7型荧光定量PCR扩增仪,采用高敏PCR法检测血清HBV DNA载量,对所有经高敏PCR法检测为HBV DNA阳性的血清再使用Cobas AmpliPrep/Cobas TaqMan全自动核酸定量检测系统复核。结果以全自动核酸定量检测系统检测结果为金标准,发现高敏PCR检测为HCV DNA阳性的67例(0.59%)为LLV人群,结果显示,该方法诊断OBI人群LLV的灵敏度和特异度均为100.0%和100.0%;金标准方法与高敏PCR检测血清HCV DNA载量差异无统计学意义【(110.7±20.2)IU/ml对(108.2±19.6)IU/ml,P>0.05】;经高敏PCR法检验发现,LLV人群血清HBV DNA载量为100～200 IU/ml者41例(61.2%),20～100 IU/ml者15例(22.4%),和<20 IU/ml者11例(16.4%);5例血清HBsAb/ HBeAb/ HBcAb阳性人群血清HBV DNA载量为(162.4±18.3) IU/ml,显著高于9例血清HBcAb阳性人群【(82.3±14.1)IU/ml,P<0.05】或16例HBeAb/ HBcAb阳性人群【(136.9±15.7)IU/ml,P<0.05】或32例HBsAb/ HBcAb阳性人群【(99.3±15.5)IU/ml,P<0.05】或3例HBsAb阳性人群【(71.5±12.9)IU/ml,P<0.05】或2例血清HBV标志物全阴性人【分别为55.0 IU/ml和56.1 IU/ml】。结论采用高敏PCR法检测血清HBV DNA载量能够在献血员人群中筛选LLV的OBI感染者,为临床用血安全又加了一道保险。

关键词: 隐匿性乙型肝炎, 低病毒血症, 精准检测HBV DNA, 无偿献血员, 筛查

Abstract: Objective The aim of this study was to explore the screening of occult hepatitis B viral infection (OBI) in unpaid blood donors with low-level viremia (LLV) by serum HBV DNA precise detection technology. Methods 11352 unpaid blood samples with negative serum hepatitis B surface antigen (HBsAg) were collected between February 2017 and December 2021. Serum hepatitis B e antigen (HBeAg), anti-hepatitis B e antibody (HBeAb), anti-hepatitis B core antibody (HBcAb) and serum anti-hepatitis B surface antibody (HBsAb) were qualitatively or quantitatively detected by CL-2000i automatic chemiluminescence immunoassay. Serum biochemical parameters were detected by AU5800 automatic biochemical analyzer. Serum HBV DNA loads were assayed by ABI ViiA7 fluorescence quantitative PCR amplifier by means of high-sensitivity PCR assay. All individuals with positive seru HBV DNA by high-sensitivity PCR assay were checked-up by Cobas AmpliPrep/Cobas TaqMan automatic nucleic acid quantitative detection system. Results The high-sensitivity PCR detection found 67 blood donors (0.59%) were serum HBV DNA positive with LLV from the 11352 blood samples, which were completely coincided with the gold method of automatic nucleic acid quantitative detection system, with the sensitivity and specificity of 100.0% (67/67) and 100.0% (67/67), respectively; there was no statistical significance as respect to serum HBV DNA loads detected by gold standard method and high-sensitivity PCR [(110.7±20.2) IU/ml vs. (108.2±19.6) IU/ml, P>0.05]; the high-sensitivity PCR detection found serum HBV DNA loads were 100-200 IU/ml in 41 cases (61.2%), 20-100 IU/ml in 15 cases (22.4%) and <20 IU/ml in 11 cases (16.4%); serum HBV DNA loads in 5 blood samples with serum HBsAb/ HBeAb/ HBcAb positive were (162.4±18.3) IU/ml, significantly higher than [(82.3±14.1)IU/ml, P<0.05] in 9 blood samples with serum HBcAb positive or [(136.9±15.7)IU/ml, P<0.05] in 16 blood samples with serum HBeAb/ HBcAb positive or [(99.3±15.5)IU/ml, P<0.05] in 32 blood samples with serum HBsAb/ HBcAb positive or [(71.5±12.9)IU/ml, P<0.05] in 3 blood samples with serum HBsAb positive or [55.0 IU/ml和56.1 IU/ml, respectively] in 2 blood samples with all serum HBV markers negative. Conclusion The screening of serum HBV DNA by high-sensitivity PCR in unpaid blood donors could reveal OBI with LLV, which might be more safe in clinical blood use.

Key words: Occult hepatitis B viral infection, HBV DNA precise detection technology, Unpaid blood donors, Low-level viremia, Screening

符鑫, 刘悦, 彭鑫, 黄婷婷, 廖雪霞, 颜悦蓉. 采用高敏检测技术检测血清HBV DNA载量筛选低病毒血症的无偿献血人群隐匿性乙型肝炎病毒感染研究^*[J]. 实用肝脏病杂志, 2023, 26(2): 169-172.

Fu Xin, Liu Yue, Peng Xin, et al.. Screening of occult hepatitis B viral infection in unpaid blood donors with low-level viremia by serum HBV DNA precise detection technology[J]. Journal of Practical Hepatology, 2023, 26(2): 169-172.

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采用高敏检测技术检测血清HBV DNA载量筛选低病毒血症的无偿献血人群隐匿性乙型肝炎病毒感染研究^*

Screening of occult hepatitis B viral infection in unpaid blood donors with low-level viremia by serum HBV DNA precise detection technology

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