Rokuhara A, Tanaka E, Matsumoto A, Kimura T, Yamaura T, Orii K, Sun X, Yagi S, Maki N, Kiyosawa K
Second Department of Internal Medicine, Shinshu University School of Medicine, Matsumoto, Japan.
J Viral Hepat. 2003 Jul;10(4):324-30. doi: 10.1046/j.1365-2893.2003.00437.x.
We aimed to assess the clinical performance of a newly developed chemiluminescence enzyme immunoassay (CLEIA) for the detection of hepatitis B virus (HBV) core-related antigen (HBcrAg) in patients with chronic HBV infection. A total of 82 patients with chronic HBV infection and 167 HBV-negative controls were studied. HBcrAg was measured by CLEIA with monoclonal antibodies to hepatitis B e antigen (HBeAg) and hepatitis B core antigen (HBcAg), and HBV DNA was measured by transcription-mediated amplification assay (TMA) and in-house real-time detection polymerase chain reaction (RTD-PCR). The HBcrAg assay detected viremia in 189 of 216 samples (88%) collected from 72 patients whilst the TMA assay detected viremia in 178 of the 216 samples (82%) (P = 0.019). The HBcrAg concentration correlated linearly with the HBV DNA concentration (P < 0.001) over a range which varied 100 000-fold. The accuracy in the measurement of the patients' HBV load obtained using the HBcrAg assay was not affected by the absence of hepatitis B e antigen from the serum or the presence of precore mutations in the HBV genome. In patients without anti-viral drugs, changes in their serum HBcrAg concentration over time corresponded to their HBV DNA concentration. In six additional patients who were later treated with lamivudine, HBV DNA concentration declined more rapidly than their HBcrAg concentration. Three months after treatment commenced, the ratio of HBcrAg: HBV DNA had increased in all six patients (P = 0.031). The HBcrAg assay is a sensitive and useful test for the assessment of a patient's HBV load. When monitoring the anti-viral effect of lamivudine, HBcrAg provides a viral marker which is independent of HBV DNA.
我们旨在评估一种新开发的化学发光酶免疫分析法（CLEIA）检测慢性乙型肝炎病毒（HBV）感染患者中HBV核心相关抗原（HBcrAg）的临床性能。共研究了82例慢性HBV感染患者和167例HBV阴性对照。采用针对乙型肝炎e抗原（HBeAg）和乙型肝炎核心抗原（HBcAg）的单克隆抗体通过CLEIA检测HBcrAg，采用转录介导扩增法（TMA）和内部实时检测聚合酶链反应（RTD-PCR）检测HBV DNA。HBcrAg检测法在从72例患者采集的216份样本中的189份（88%）检测到病毒血症，而TMA检测法在216份样本中的178份（82%）检测到病毒血症（P = 0.019）。在相差100000倍的范围内，HBcrAg浓度与HBV DNA浓度呈线性相关（P < 0.001）。使用HBcrAg检测法测量患者HBV载量的准确性不受血清中乙型肝炎e抗原缺失或HBV基因组中前核心区突变的影响。在未使用抗病毒药物的患者中，其血清HBcrAg浓度随时间的变化与HBV DNA浓度相对应。在另外6例随后接受拉米夫定治疗的患者中，HBV DNA浓度下降速度比HBcrAg浓度更快。治疗开始3个月后，所有6例患者的HBcrAg:HBV DNA比值均升高（P = 0.031）。HBcrAg检测法是评估患者HBV载量的一种灵敏且有用的检测方法。在监测拉米夫定的抗病毒效果时，HBcrAg提供了一种独立于HBV DNA的病毒标志物。
