Weverling G J, Lange J M, de Jong M D, de Weerd H, Goudsmit J, de Wolf F
National AIDS Therapy Evaluation Center, Department of Clinical Epidemiology and Biostatistics, University of Amsterdam, The Netherlands.
Antivir Ther. 1996 Dec;1(4):255-63.
HIV-1 RNA levels as measured by two commercially available quantitative assays were compared before and during zidovudine treatment. HIV-1 RNA levels were measured in stored serum samples from 24 Dutch zidovudine-treated participants of a zidovudine efficacy study (European-Australian Collaborative Group Study 017) at weeks -3, 0, 4 and 8, using quantitative nucleic acid sequence-based amplification (NASBA; Organon Technika) and quantitative reverse transcriptase-polymerase chain reaction (Amplicor; Roche Molecular Systems). HIV-1 RNA copy numbers and changes from baseline as measured by each assay were compared. Individual responses to treatment were compared using definitions based on the within-subject variation of each assay. Before treatment, HIV-1 RNA levels as measured by NASBA were 0.49 logs higher than the levels measured by the Amplicor assay (95% confidence interval (CI) 0.32-0.66). During treatment, this difference decreased significantly to 0.27 logs (95% CI 0.01-0.53; difference 0.22 logs; 95% CI 0.05-0.37). The smaller difference between the results of the two assays during treatment was a consequence of a larger decline in RNA level as measured by NASBA compared with that measured by the Amplicor assay (mean change after 4 weeks 0.77 and 0.49 logs, respectively). At week 8, the mean HIV-1 RNA level was still significantly below baseline values as measured by NASBA, but not when measured by the Amplicor assay. Discrepancies in individual responses as measured by the two assays were also observed. In conclusion, marked differences exist between the NASBA and Amplicor quantitative assays, in both HIV-1 RNA copy numbers without treatment and changes in RNA level during treatment. These differences should be considered in interpreting analyses of clinical trials and relationships between HIV-1 RNA level and clinical outcome, as well as in the use of RNA level in the management of HIV-infected patients.
在齐多夫定治疗前及治疗期间，对通过两种市售定量检测方法测得的HIV-1 RNA水平进行了比较。在一项齐多夫定疗效研究（欧洲-澳大利亚协作组研究017）中，对24名接受齐多夫定治疗的荷兰参与者的储存血清样本，在第-3、0、4和8周时，使用基于核酸序列的定量扩增技术（NASBA；Organon Technika公司）和定量逆转录聚合酶链反应（Amplicor；罗氏分子系统公司）检测HIV-1 RNA水平。比较了每种检测方法测得的HIV-1 RNA拷贝数及其相对于基线的变化。使用基于每种检测方法的个体内变异的定义比较了个体对治疗的反应。治疗前，通过NASBA测得的HIV-1 RNA水平比通过Amplicor检测法测得的水平高0.49个对数（95%置信区间[CI] 0.32 - 0.66）。治疗期间，这种差异显著减小至0.27个对数（95% CI 0.01 - 0.53；差异为0.22个对数；95% CI 0.05 - 0.37）。两种检测方法在治疗期间结果的差异较小，是因为与通过Amplicor检测法测得的RNA水平下降相比，NASBA测得的RNA水平下降幅度更大（4周后的平均变化分别为0.77和0.49个对数）。在第8周时，通过NASBA测得的HIV-1 RNA平均水平仍显著低于基线值，但通过Amplicor检测法测得时则不然。还观察到两种检测方法测得的个体反应存在差异。总之，在未治疗时的HIV-1 RNA拷贝数以及治疗期间RNA水平的变化方面，NASBA和Amplicor定量检测方法之间存在显著差异。在解释临床试验分析以及HIV-1 RNA水平与临床结果之间的关系时，以及在HIV感染患者管理中使用RNA水平时，应考虑这些差异。
