Liao Chen-Chih, Hsu Chao-Wei, Gu Po-Wen, Yeh Chau-Ting, Lin Shi-Ming, Chiu Cheng-Tang
Department of Gastroenterology and Hepatology, Chang Gung Memorial Hospital at Linkou, Chang Gung University College of Medicine, Taoyuan, Taiwan.
Biomed J. 2015 May-Jun;38(3):250-6. doi: 10.4103/2319-4170.143485.
Hepatitis B virus (HBV) infection is one of the infections with a highest prevalence in Taiwan. The most important marker is hepatitis B surface antigen (HBsAg). Using the new generation of HBsAg quantitative assay, HBsAg level may have good correlation with viral activity during different phases of chronic hepatitis B virus infection. This study was conducted to compare two assays of HBsAg level to find if the same results are obtained in HBsAg quantification in treatment-naïve and on-treatment chronic hepatitis B patients.
Between March 2012 and June 2012, 90 patients with chronic hepatitis B (68 males and 22 females) were assessed using Abbott Architect HBsAg QT and Roche Elecsys HBsAg II assay. HBV DNA was detected by Roche COBAS TaqMan instrument.
HBsAg level measured with Elecsys and Architect assays correlated well in untreated patients (n = 53, γs = 0.997) and on-treatment patients (n = 37, γs = 0.988). Bland-Altman analyses of the discrepancies in HBsAg levels showed a bias of -4.2% in untreated patients and -6.2% in on-treatment patients. Patients with HBeAg-postive chronic hepatitis B had higher HBsAg level than the ones who were HBeAg negative, and both showed statistical differences. Further, HBV DNA concentration analysis also showed higher viral concentration in HBeAg-positive patients, but it revealed no statistical difference.
There is a significant correlation between Abbott Architect HBsAg QT assay and Roche Elecsys HBsAg II assay. Moreover, HBsAg quantification may potentially provide complementary information about the deduction of the natural course in chronic hepatitis B infection.
乙肝病毒（HBV）感染是台湾地区感染率最高的疾病之一。最重要的标志物是乙肝表面抗原（HBsAg）。使用新一代HBsAg定量检测方法，HBsAg水平在慢性乙肝病毒感染的不同阶段可能与病毒活性具有良好的相关性。本研究旨在比较两种HBsAg水平检测方法，以确定初治和正在接受治疗的慢性乙肝患者的HBsAg定量检测结果是否相同。
2012年3月至2012年6月期间，使用雅培Architect HBsAg QT和罗氏Elecsys HBsAg II检测方法对90例慢性乙肝患者（68例男性和22例女性）进行评估。通过罗氏COBAS TaqMan仪器检测HBV DNA。
Elecsys和Architect检测方法测得的HBsAg水平在未治疗患者（n = 53，γs = 0.997）和正在接受治疗的患者（n = 37，γs = 0.988）中具有良好的相关性。对HBsAg水平差异进行的Bland-Altman分析显示，未治疗患者的偏差为-4.2%，正在接受治疗的患者偏差为-6.2%。HBeAg阳性的慢性乙肝患者的HBsAg水平高于HBeAg阴性患者，并均显示出统计学差异。此外，HBV DNA浓度分析也显示HBeAg阳性患者的病毒浓度较高，但未显示出统计学差异。
雅培Architect HBsAg QT检测方法与罗氏Elecsys HBsAg II检测方法之间存在显著相关性。此外，HBsAg定量检测可能为推断慢性乙肝感染的自然病程提供补充信息。
