Gleaves Curt A, Welle John, Campbell Mary, Elbeik Tarek, Ng Valerie, Taylor Patricia E, Kuramoto Ken, Aceituno Sherri, Lewalski Eva, Joppa Barbara, Sawyer Lynette, Schaper Carl, McNairn Denise, Quinn Thomas
Infectious Disease Laboratory, Providence Portland Medical Center, Portland, OR 97213, USA.
J Clin Virol. 2002 Aug;25(2):205-16. doi: 10.1016/s1386-6532(02)00011-2.
The use of quantitative HIV-1 RNA assays is part of the standard of care for the management of HIV-1-infected individuals.
The Bayer VERSANT HIV-1 RNA 3.0 Assay (bDNA) was evaluated for reproducibility, linearity, limits of detection and quantitation, effects of potentially interfering substances and conditions, effects of plasma collection and handling conditions, clinical sensitivity and specificity, and biologic variability.
Anti-HIV-1-positive specimens, patient specimens containing potentially interfering substances, and anti-HIV-negative specimens were collected from several HIV clinics, blood centers, or commercial companies across the United States. Specimen panels used to evaluate nonclinical performance of the assay were prepared at Bayer Diagnostics. Bayer Assay Development personnel performed 2 of the nonclinical studies-effect of freeze-thaw cycles using 'spiked' HIV-1 RNA-positive samples and effect of other disease organisms. All other studies were conducted at 7 external sites. In some of the studies performed, specimens were tested in parallel with the Roche AMPLICOR HIV-1 MONITOR version 1.0 PCR Test.
RESULTS/CONCLUSIONS: The results of these studies showed that the Bayer Assay has excellent reproducibility, a broad linear range (75-500,000 HIV-1 RNA copies/ml), throughput of 168 patient results per two-plate run in a 22-h period, and few limitations for use. Because this test is designed for use only in individuals who are known to be HIV-1-positive, the clinical specificity of 97.6% is adequate for its intended use. These characteristics make it an attractive method for general laboratory use of monitoring HIV-1-infected patients.
定量检测HIV-1 RNA是管理HIV-1感染个体的标准治疗的一部分。
对拜耳VERSANT HIV-1 RNA 3.0检测法（分支DNA法）的重复性、线性、检测和定量限、潜在干扰物质和条件的影响、血浆采集和处理条件的影响、临床敏感性和特异性以及生物学变异性进行评估。
从美国各地的几家HIV诊所、血液中心或商业公司收集抗HIV-1阳性标本、含有潜在干扰物质的患者标本以及抗HIV阴性标本。用于评估该检测法非临床性能的标本板由拜耳诊断公司制备。拜耳检测法开发人员进行了两项非临床研究，即使用“加标”HIV-1 RNA阳性样本进行冻融循环的影响以及其他致病生物的影响。所有其他研究均在7个外部地点进行。在一些进行的研究中，标本与罗氏AMPLICOR HIV-1 MONITOR 1.0版PCR检测法平行检测。
结果/结论：这些研究结果表明，拜耳检测法具有出色的重复性、较宽的线性范围（每毫升75 - 500,000个HIV-1 RNA拷贝）、在22小时内每两板运行可产出168个患者检测结果的通量以及较少的使用限制。由于该检测法仅设计用于已知HIV-阳性个体，其97.6%的临床特异性足以满足其预期用途。这些特性使其成为普通实验室监测HIV-1感染患者的一种有吸引力的方法。
