Yao Joseph D C, Beld Marcel G H M, Oon Lynette Lin Ean, Sherlock Christopher H, Germer Jeffrey, Menting Sandra, Se Thoe Su Yun, Merrick Linda, Ziermann Rainer, Surtihadi Johan, Hnatyszyn H James
Division of Clinical Microbiology, Mayo Clinic, Rochester, Minnesota, USA.
J Clin Microbiol. 2004 Feb;42(2):800-6. doi: 10.1128/JCM.42.2.800-806.2004.
The VERSANT hepatitis B virus (HBV) 3.0 Assay (branched DNA [bDNA]) (referred to herein as VERSANT 3.0) was evaluated at four external sites for analytical sensitivity, specificity, reproducibility, linearity of quantification, and limits of detection. In addition, each of the test evaluation sites provided HBV DNA-positive clinical samples that were previously analyzed by one of three commercially available HBV DNA quantitative tests: Digene Hybrid Capture II HBV DNA Test (Digene); VERSANT HBV DNA 1.0 Assay (bDNA) (VERSANT 1.0); and COBAS AMPLICOR HBV Monitor Test (COBAS AMPLICOR). These samples were reexamined using VERSANT 3.0. The results from these studies showed that VERSANT 3.0 has high specificity (99.3%), excellent reproducibility (between-run coefficient of variation [CV] = 1.6 to 9.4%; within-run CV = 6.5 to 20.7%), and a broad linear range of quantification (2.0 x 10(3) to 1.0 x 10(8) HBV DNA copies/ml) that facilitate the monitoring of HBV DNA levels at diagnosis and throughout the course of treatment. In general, correlation was very good between results obtained from clinical samples analyzed by VERSANT 3.0 and the comparative HBV DNA quantitative assays (VERSANT 1.0, R(2) = 0.900; Digene, R(2) = 0.985; COBAS AMPLICOR, R(2) = 0.771). The greatest differences in comparative quantitation occurred at HBV DNA levels approaching the limits of the dynamic ranges for the comparative assays. The performance characteristics of the new VERSANT 3.0 assay demonstrated that it provides a reliable and robust method for routinely monitoring serum HBV DNA levels in assessing disease activity and determining response to antiviral treatment.
在四个外部站点对VERSANT乙型肝炎病毒（HBV）3.0检测法（分支DNA [bDNA]）（以下简称VERSANT 3.0）进行了分析灵敏度、特异性、可重复性、定量线性及检测限的评估。此外，每个检测评估站点都提供了HBV DNA阳性临床样本，这些样本之前已通过三种市售HBV DNA定量检测法之一进行过分析：Digene杂交捕获II HBV DNA检测法（Digene）；VERSANT HBV DNA 1.0检测法（bDNA）（VERSANT 1.0）；以及COBAS AMPLICOR HBV监测检测法（COBAS AMPLICOR）。使用VERSANT 3.0对这些样本进行了重新检测。这些研究结果表明，VERSANT 3.0具有高特异性（99.3%）、出色的可重复性（批间变异系数[CV] = 1.6%至9.4%；批内CV = 6.5%至20.7%）以及较宽的定量线性范围（2.0×10³至1.0×10⁸ HBV DNA拷贝/毫升），便于在诊断时及整个治疗过程中监测HBV DNA水平。总体而言，VERSANT 3.0分析的临床样本结果与比较性HBV DNA定量检测法（VERSANT 1.0，R² = 0.900；Digene，R² = 0.985；COBAS AMPLICOR，R² = 0.771）之间的相关性非常好。比较定量中最大的差异出现在接近比较检测法动态范围极限的HBV DNA水平处。新型VERSANT 3.0检测法的性能特征表明，它为在评估疾病活动及确定对抗病毒治疗的反应时常规监测血清HBV DNA水平提供了一种可靠且稳健的方法。
