Clinical evaluation of a new enzyme immunoassay for hepatitis B virus core-related antigen; a marker distinct from viral DNA for monitoring lamivudine treatment
Clinical evaluation of a new enzyme immunoassay for hepatitis B virus core-related antigen; a marker distinct from viral DNA for monitoring lamivudine treatment
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DOI：
10.1046/j.1365-2893.2003.00437.x
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发表时间：
2003-07-01
影响因子：
2.5
通讯作者：
Kiyosawa, K
中科院分区：
文献类型：
--
作者：
Rokuhara, A;Tanaka, E;Kiyosawa, K
我们的目的是评估新开发的化学发光酶免疫分析 (CLEIA) 用于检测慢性 HBV 感染患者乙型肝炎病毒 (HBV) 核心相关抗原 (HBcrAg) 的临床表现。共有 82 名慢性 HBV 感染患者和 167 名 HBV 阴性对照进行了研究。 HBcrAg 通过 CLEIA 使用乙型肝炎 e 抗原 (HBeAg) 和乙型肝炎核心抗原 (HBcAg) 单克隆抗体进行测量，HBV DNA 通过转录介导扩增测定 (TMA) 和内部实时检测聚合酶链反应 (RTD-PCR) 进行测量。 HBcrAg 检测在 72 名患者收集的 216 个样本中的 189 个样本 (88%) 中检测到病毒血症，而 TMA 检测在 216 个样本中的 178 个样本 (82%) 中检测到病毒血症 (P = 0.019)。 HBcrAg 浓度与 HBV DNA 浓度在变化 100 000 倍的范围内呈线性相关 (P < 0.001)。使用 HBcrAg 测定获得的患者 HBV 载量测量的准确性不受血清中乙型肝炎 e 抗原缺失或 HBV 基因组中存在前核心突变的影响。在未服用抗病毒药物的患者中，血清 HBcrAg 浓度随时间的变化与其 HBV DNA 浓度相对应。在后来接受拉米夫定治疗的另外 6 名患者中，HBV DNA 浓度下降速度快于 HBcrAg 浓度。治疗开始三个月后，所有 6 名患者的 HBcrAg: HBV DNA 比率均有所增加 (P = 0.031)。 HBcrAg 测定是评估患者 HBV 载量的敏感且有用的测试。当监测拉米夫定的抗病毒作用时，HBcrAg 提供了独立于 HBV DNA 的病毒标记物。
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.