Dai C-Y, Yu M-L, Chen S-C, Lin Z-Y, Hsieh M-Y, Wang L-Y, Tsai J-F, Chuang W-L, Chang W-Y
Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University, Kaohsiung 807, Taiwan.
J Clin Pathol. 2004 Feb;57(2):141-5. doi: 10.1136/jcp.2003.10835.
To evaluate the performance characteristics and clinical usefulness of the COBAS Amplicor HBV monitor (COBAS-AM) test in Taiwan and to examine its correlation with the Quantiplex branched DNA signal amplification (bDNA) assay for measuring serum hepatitis B virus (HBV) DNA concentrations.
HBV DNA was measured by the COBAS-AM test in 149 sera from chronic HBV infected patients that had previously been analysed by the bDNA assay.
The COBAS-AM test showed good reproducibility, with acceptable intra-assay and interassay coefficients of variation (1.6% and 0.9%, respectively) and good linearity (r2=0.98). The overall sensitivity of the COBAS-AM test was significantly higher than that of the bDNA assay (95.3% v 83.2%): 69.6% of samples with HBV DNA below the detection limit of the bDNA assay could be measured by the COBAS-AM test. There was a significant correlation between the results of the two assays (r=0.901; p<0.0001). On average, the results derived from the COBAS-AM test were 0.55 log lower than those of the bDNA assay. HBV DNA concentrations were significantly higher among HBV e antigen (HBeAg) positive patients than negative ones, and higher among patients with abnormal alanine aminotransferase (ALT) concentrations than those with normal ALT concentrations (p=0.0003).
The COBAS-AM assay, more sensitive in HBeAg negative samples than the bDNA assay, can effectively measure HBV DNA concentrations in Taiwanese patients. HBV DNA values measured by the COBAS-AM test and bDNA assay correlate significantly.
评估COBAS Amplicor HBV监测仪（COBAS - AM）检测在台湾地区的性能特征和临床实用性，并检验其与用于检测血清乙型肝炎病毒（HBV）DNA浓度的Quantiplex分支DNA信号扩增（bDNA）检测法的相关性。
采用COBAS - AM检测法对149份慢性HBV感染患者的血清进行HBV DNA检测，这些血清此前已通过bDNA检测法进行过分析。
COBAS - AM检测法显示出良好的重复性，批内和批间变异系数均可接受（分别为1.6%和0.9%），且线性良好（r2 = 0.98）。COBAS - AM检测法的总体灵敏度显著高于bDNA检测法（95.3%对83.2%）：bDNA检测法检测限以下的HBV DNA样本中有69.6%可被COBAS - AM检测法测出。两种检测法的结果之间存在显著相关性（r = 0.901；p < 0.0001）。平均而言，COBAS - AM检测法得出的结果比bDNA检测法低0.55个对数。HBV e抗原（HBeAg）阳性患者的HBV DNA浓度显著高于阴性患者，丙氨酸氨基转移酶（ALT）浓度异常的患者高于ALT浓度正常的患者（p = 0.0003）。
COBAS - AM检测法在HBeAg阴性样本中比bDNA检测法更灵敏，能够有效检测台湾患者的HBV DNA浓度。COBAS - AM检测法和bDNA检测法测得的HBV DNA值显著相关。
