Department of Laboratory Medicine, Chung-Ang University College of Medicine, Seoul, Republic of Korea.
J Virol Methods. 2013 Nov;193(2):492-7. doi: 10.1016/j.jviromet.2013.07.027. Epub 2013 Jul 25.
The performance of a recently developed real-time PCR system, the ExiStation HBV diagnostic system, for quantitation of hepatitis B virus (HBV) in human blood was evaluated. The detection limit, reproducibility, cross-reactivity, and interference were evaluated as measures of analytical performance. For the comparison study, 100 HBV-positive blood samples and 100 HBV-negative samples from Korean Blood Bank Serum were used, and the results of the ExiStation HBV system showed good correlation with those obtained using the Cobas TaqMan (r2=0.9931) and Abbott real-time PCR systems (r2=0.9894). The lower limit of detection was measured as 9.55 IU/mL using WHO standards and the dynamic range was linear from 6.68 to 6.68×10(9) IU/mL using cloned plasmids. The within-run coefficient of variation (CV) was 9.4%, 2.1%, and 1.1%, and the total CV was 11.8%, 3.6%, and 1.7% at a concentration of 1.92 log10 IU/mL, 3.88 log10 IU/mL, and 6.84 log10 IU/mL, respectively. No cross-reactivity or interference was detected. The ExiStation HBV diagnostic system showed satisfactory analytical sensitivity, excellent reproducibility, no cross-reactivity, no interference, and high agreement with the Cobas TaqMan and Abbott real-time PCR systems, and is therefore a useful tool for the detection and monitoring of HBV infection.
最近开发的实时 PCR 系统 ExiStation HBV 诊断系统用于定量检测人血液中的乙型肝炎病毒 (HBV)。评估了检测限、重现性、交叉反应性和干扰作为分析性能的指标。在比较研究中，使用了来自韩国血液银行血清的 100 份 HBV 阳性血液样本和 100 份 HBV 阴性样本，ExiStation HBV 系统的结果与 Cobas TaqMan（r2=0.9931）和 Abbott 实时 PCR 系统的结果显示出良好的相关性（r2=0.9894）。使用世界卫生组织标准测量的检测下限为 9.55 IU/mL，使用克隆质粒的动态范围从 6.68 到 6.68×10(9) IU/mL 呈线性。在浓度为 1.92 log10 IU/mL、3.88 log10 IU/mL 和 6.84 log10 IU/mL 时，批内变异系数 (CV) 分别为 9.4%、2.1%和 1.1%，总 CV 分别为 11.8%、3.6%和 1.7%。未检测到交叉反应或干扰。ExiStation HBV 诊断系统显示出令人满意的分析灵敏度、出色的重现性、无交叉反应、无干扰，与 Cobas TaqMan 和 Abbott 实时 PCR 系统高度一致，因此是检测和监测乙型肝炎病毒感染的有用工具。
