Yu M L, Chuang W L, Chen S C, Lin Z Y, Hsieh M Y, Wang L Y, Chang W Y
Department of Internal Medicine, Kaohsiung Medical College Hospital, Taiwan, Republic of China.
J Clin Pathol. 1999 Nov;52(11):807-11. doi: 10.1136/jcp.52.11.807.
To compare the performance characteristics and clinical application of two different technologies for quantifying serum hepatitis C virus (HCV) RNA levels.
HCV RNA was quantified by Amplicor HCV Monitor assay (Amplicor) and Quantiplex HCV RNA 2.0 assay (bDNA-2) in 119 sera from 107 HCV infected patients.
Both assays had similar sensitivity (79.4% for Amplicor; 86.0% for bDNA-2), acceptable coefficients of variation (5.3% in Amplicor; 2.6% in bDNA-2), and good linearity (r2 > or = 0.98). There was a positive correlation between quantification values of both methods (r = 0.683, p < 0.001). The Amplicor values were on an average 1.76 log lower than bDNA-2 results. Male subjects and HCV genotype 1b were significantly associated with higher viral load determined by Amplicor, but not with viral load measured by bDNA-2. In 70 chronic HCV infected patients treated with interferon alfa, mean (SD) pretreatment viral load in 27 complete responders (3.47 (0.84) logs for Amplicor, 5.63 (0.58) for bDNA-2) was significantly lower than in non-responders (4.43 (1.01) logs for Amplicor, 6.10 (0.67) logs for bDNA-2; p < 0.001). Cut off points of 3.9 logs for Amplicor and 5.8 logs for bDNA-2 were determined to be the best for predicting response to interferon alfa, giving acceptable sensitivity (70.4%, 74.1%), specificity (72.1%, 65.1%), and accuracy (71.4%, 68.6%), respectively.
Both the Amplicor and bDNA-2 assays are clinically useful methods for HCV RNA quantification and are reliable for predicting the outcome of treatment, despite differences in absolute quantification values and in the correlation between HCV genotypes and viral load.
比较两种不同技术定量血清丙型肝炎病毒（HCV）RNA水平的性能特征及临床应用。
采用Amplicor HCV Monitor检测法（Amplicor）和Quantiplex HCV RNA 2.0检测法（bDNA - 2）对107例HCV感染患者的119份血清进行HCV RNA定量检测。
两种检测方法具有相似的灵敏度（Amplicor为79.4%；bDNA - 2为86.0%）、可接受的变异系数（Amplicor为5.3%；bDNA - 2为2.6%）以及良好的线性关系（r2≥0.98）。两种方法的定量值之间存在正相关（r = 0.683，p < 0.001）。Amplicor检测值平均比bDNA - 2结果低1.76个对数。男性受试者和HCV基因1b型与Amplicor检测的较高病毒载量显著相关，但与bDNA - 2检测的病毒载量无关。在70例接受干扰素α治疗的慢性HCV感染患者中，27例完全应答者的平均（标准差）治疗前病毒载量（Amplicor为3.47（0.84）个对数，bDNA - 2为5.63（0.58）个对数）显著低于无应答者（Amplicor为4.43（1.01）个对数，bDNA - 2为6.10（0.67）个对数；p < 0.001）。确定Amplicor的截断值为3.9个对数，bDNA - 2的截断值为5.8个对数，这对于预测干扰素α治疗反应是最佳的，其灵敏度（分别为70.4%，74.1%）、特异性（分别为72.1%，65.1%）和准确性（分别为71.4%，68.6%）均可接受。
尽管绝对定量值以及HCV基因型与病毒载量之间的相关性存在差异，但Amplicor和bDNA - 2检测法都是临床上用于HCV RNA定量的有用方法，并且对于预测治疗结果是可靠的。
