Lin Ya-Yun, Huang Jee-Fu, Liu Shu-Fen, Yu Ming-Lung, Tsai Chiu-Hung, Yang Jeng-Fu, Lin I-Ling, Dai Chia-Yen, Lin Zu-Yau, Chen Shinn-Chern, Chang Wen-Yu, Chuang Wan-Long
Department of Preventive Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan.
Scand J Infect Dis. 2009;41(8):614-8. doi: 10.1080/00365540902875073.
Detection and quantification for hepatitis B virus (HBV) DNA has been an essential tool in the clinical setting. We aimed to assess clinical performance of the RealArt HBV TM PCR (RealArt) assay and the COBAS TaqMan HBV (COBAS) assay. Serum levels of HBV DNA in 146 treatment-naïve chronic HBV (CHB) Taiwanese patients (118 males, 47 HBeAg + ; mean age, 34.7+/-13.0 y) were determined by both assays. The detection rate by the RealArt assay was 85.6% (125/146), which was not significantly different from the COBAS assay (89.7%, 131/146). The detection rate was also not significantly different between both assays irrespective of HBeAg seropositivity. The 2 assays were also comparable regarding quantification rate (92.8%, 116/125 vs 93.1%, 122/131). There was a positive correlation in the 109 specimens measurable by both assays (r=0.94,p<0.001). The mean HBV DNA level measured by the COBAS assay was significantly higher than the RealArt assay (5.24+/-1.83 vs 4.79+/-2.09 log IU/ml, p<0.001). This study demonstrated that both RealArt and COBAS assays were comparable regarding clinical performance in HBV DNA measurement.
乙型肝炎病毒（HBV）DNA的检测和定量一直是临床诊断中的重要手段。我们旨在评估RealArt HBV TM PCR检测法（RealArt）和COBAS TaqMan HBV检测法（COBAS）的临床性能。通过这两种检测法测定了146例未经治疗的台湾慢性HBV（CHB）患者（118例男性，47例HBeAg阳性；平均年龄34.7±13.0岁）的血清HBV DNA水平。RealArt检测法的检出率为85.6%（125/146），与COBAS检测法（89.7%，131/146）无显著差异。无论HBeAg血清学阳性与否，两种检测法的检出率也无显著差异。在定量率方面，两种检测法也具有可比性（92.8%，116/125 vs 93.1%，122/131）。在两种检测法均可检测的109份样本中存在正相关（r = 0.94，p < 0.001）。COBAS检测法测得的平均HBV DNA水平显著高于RealArt检测法（5.24±1.83 vs 4.79±2.09 log IU/ml，p < 0.001）。本研究表明，在HBV DNA检测的临床性能方面，RealArt和COBAS检测法具有可比性。
