Shinkai Noboru, Tanaka Yasuhito, Matsuura Kentaro, Kani Satomi, Naganuma Hatsue, Mizokami Masashi
Department of Virology, Nagoya City University Graduate School of Medical Sciences, Nagoya 467-8601, Japan.
Rinsho Byori. 2010 Nov;58(11):1078-84.
A high sensitive chemiluminescent enzyme immunoassay (CLEIA) was developed for quantitative hepatitis B surface antigen (HBsAg) detection by a combination of monoclonal antibodies, each one for a specific epitope of HBsAg, and by improving the conjugation technique (Matsubara, et al. Transfusion 2009). We modified and automated Matsubara's techniques. Our aim is to evaluate the fundamental performance of our assay (prototype) and to investigate the clinical significance of prototype in patients with hepatitis B virus (HBV) infection.
We used 226 HBsAg-negative samples and 59 HBsAg-positive samples for evaluation of prototype's accuracy, reproducibility, specificity and sensitivity. We examine correlation between the prototype assay and commercial quantitative HBsAg detection assay (the Abbott ARCHITECT). Performance of prototype was compared with the Abbott ARCHITECT in one chronic hepatitis B patient and one patient with HBsAg seroconversion sequentially.
The prototype assay had good accuracy, reproducibility, specificity and sensitivity. There is positive correlation between the prototype and the Abbott ARCHITECT. The sensitivity of the prototype (5 mIU/mL) was approximately 10 fold higher than the Abbott ARCHITECT (50 mIU/ml). The prototype could detect HBsAg at the HBsAg-negative point by Abbott ARCHITECT in these patients.
Automatic highly sensitive HBsAg CLEIA prototype is convenient and precise assay for HBV monitoring.
通过结合针对乙肝表面抗原（HBsAg）特定表位的单克隆抗体，并改进偶联技术（松原等人，《输血》，2009年），开发一种用于定量检测乙肝表面抗原（HBsAg）的高灵敏度化学发光酶免疫分析方法（CLEIA）。我们对松原的技术进行了改进并实现自动化。我们的目的是评估我们的分析方法（原型）的基本性能，并研究该原型在乙肝病毒（HBV）感染患者中的临床意义。
我们使用226份HBsAg阴性样本和59份HBsAg阳性样本评估原型的准确性、重复性、特异性和灵敏度。我们检测了原型分析方法与商业定量HBsAg检测方法（雅培ARCHITECT）之间的相关性。在一名慢性乙肝患者和一名HBsAg血清学转换患者中，依次比较了原型与雅培ARCHITECT的性能。
原型分析方法具有良好的准确性、重复性、特异性和灵敏度。原型与雅培ARCHITECT之间存在正相关关系。原型的灵敏度（5 mIU/mL）比雅培ARCHITECT（50 mIU/ml）高约10倍。在这些患者中，原型能够检测到雅培ARCHITECT检测为HBsAg阴性点的HBsAg。
自动高灵敏度HBsAg CLEIA原型是用于HBV监测的便捷精确分析方法。
