Gupta E, Pandey P, Kumar A, Sharma M K, Sarin S K
Department of Virology , Institute of Liver and Biliary Sciences, Vasant Kunj, New Delhi, India.
Indian J Med Microbiol. 2015 Jan-Mar;33(1):96-100. doi: 10.4103/0255-0857.148400.
Hepatitis B surface Antigen (HBsAg) is the hallmark in diagnosing hepatitis B virus (HBV) infection. In India many commercial assays are available for detection of HBsAg but very few can measure it quantitatively. The present study presents the comparative evaluation of two methods and their correlation with serum HBsAg in chronic hepatitis B (CHB) patients.
Consecutive patients of CHB were included and there HBsAg levels were measured by two methods: (i) Elecsys, Roche Diagnostics, a qualitative assay and (ii) Architect, Abbott Diagnostics, a quantitative assay. The HBV DNA was measured by real-time polymerase chain reaction (qPCR).
Total of 136 patients were included in the study and there was a significant overall correlation between both the assays (correlation coefficient [r] = 0.83; P < 0.001). Assays correlated well with each other across all subgroups of CHB: treatment naοve (r = 0.73; P < 0.001, n = 32), on treatment (r = 0.56; P < 0.05, n = 104), hepatitis Be (HBe) antigen positive (r = 0.67; P < 0.001, n = 62) and anti-HBe positive (r = 0.61; P < 0.05, n = 74) group. On correlation with serum HBV DNA, Architect assay demonstrated good correlation (r = 0.73; P < 0.001, n = 136) as compared to the Elecsys assay (r = 0.27; P = 0.068, n = 136). Architect HBsAg QT assay (A1) also correlated well with HBV DNA in the treatment naοve group (r = 0.69; P < 0.001, n = 32).
Our study hence proved that both the assays are comparable and a simple qualitative assay with in-house modification can be used easily for quatitation of HBsAg in clinical samples.
乙肝表面抗原（HBsAg）是诊断乙肝病毒（HBV）感染的标志。在印度，有许多商业检测方法可用于检测HBsAg，但很少有能进行定量检测的。本研究对两种方法进行了比较评估，并研究了它们与慢性乙型肝炎（CHB）患者血清HBsAg的相关性。
纳入连续的CHB患者，采用两种方法检测其HBsAg水平：（i）罗氏诊断公司的Elecsys，一种定性检测方法；（ii）雅培诊断公司的Architect，一种定量检测方法。采用实时聚合酶链反应（qPCR）检测HBV DNA。
本研究共纳入136例患者，两种检测方法之间存在显著的总体相关性（相关系数[r]=0.83；P<0.001）。在CHB的所有亚组中，两种检测方法相互之间相关性良好：初治组（r=0.73；P<0.001，n=32）、治疗中组（r=0.56；P<0.05，n=104）、乙肝e抗原（HBe）阳性组（r=0.67；P<0.001，n=62）和抗-HBe阳性组（r=0.61；P<0.05，n=74）。与血清HBV DNA相关性方面，Architect检测方法显示出良好的相关性（r=0.73；P<0.001，n=136），而Elecsys检测方法的相关性为（r=0.27；P=0.068，n=136）。Architect HBsAg QT检测方法（A1）在初治组中与HBV DNA也具有良好的相关性（r=0.69；P<0.001，n=32）。
我们的研究因此证明，两种检测方法具有可比性，一种经过内部改良的简单定性检测方法可轻松用于临床样本中HBsAg的定量检测。
