Concordance of HIV-1 RNA Values by Amplicor and TaqMan 2.0 in Patients With Confirmed Suppression in Clinical Trials.
Concordance of HIV-1 RNA Values by Amplicor and TaqMan 2.0 in Patients With Confirmed Suppression in Clinical Trials.
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Amplicor 和 TaqMan 2.0 在临床试验中确认受到抑制的患者中 HIV-1 RNA 值的一致性。
DOI：
10.1093/cid/civ1034
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发表时间：
2016
期刊：
影响因子：
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通讯作者：
Wulfsohn,Mike
中科院分区：
文献类型：
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作者：
Garner,Will;White,Kirsten;Szwarcberg,Javier;McCallister,Scott;Zhong,Lijie;Wulfsohn,Mike
背景.COBAS AMPLICOR HIV-1 MONITOR 测试 1.5 版 (Amplicor) 已被 COBAS AmpliPrep/COBAS TaqMan HIV-1 测试 2.0 版 (TaqMan 2.0) 取代，后者是一种实时聚合酶链反应人类免疫缺陷病毒 1 型 (HIV-1) 检测，具有更高的灵敏度和更宽的动态范围。 50 拷贝/mL 截止值的 HIV-1 RNA 值驱动主要的患者管理决策和临床研究结果。方法。从接受抗逆转录病毒治疗至少 48 周的 1922 名 HIV-1 感染受试者中总共收集了 2217 个样本，Amplicor 从最近的 7 项临床试验中获得了至少 2 个连续样本的 HIV-1 RNA <50 拷贝/mL。 HIV-1 RNA 结果由参考实验室通过 Amplicor 和 TaqMan 2.0 平行检测获得。结果。在 50 拷贝/mL 的截止值下，检测结果之间的总体一致性为 96%。然而，在 3.9% 的样品 (n = 87) 的测定之间发现 50 拷贝/mL 截止值存在统计学上显着的不一致。通过 TaqMan 2.0，报告的病毒学失败（定义为 HIV-1 RNA ≥50 拷贝/mL）的样本比 Amplicor 多 2.8%。在这 87 个样品中，68 个样品落在检测变异性的预测范围内。 TaqMan 2.0 对 HIV-1 RNA 的重新测试证实了 87 个样本中只有 28 个样本存在不一致。结论。与 Amplicor 测定相比，TaqMan 2.0 测定在 HIV 临床试验中报告的低于 HIV-1 RNA <50 拷贝/mL 临床终点的受试者较少。在评估疾病进展、设计临床试验以及与使用 Amplicor 检测的历史试验进行比较时，必须考虑这种差异。
Background.The COBAS AMPLICOR HIV-1 MONITOR Test, version 1.5 (Amplicor) has been replaced with the COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, version 2.0 (TaqMan 2.0), a real-time polymerase chain reaction human immunodeficiency virus type 1 (HIV-1) assay with higher sensitivity and broader dynamic range. HIV-1 RNA values at the 50 copies/mL cutoff drive major patient management decisions and clinical study outcomes.Methods.A total of 2217 samples were collected from 1922 HIV-1–infected subjects taking antiretroviral therapy for at least 48 weeks and had at least 2 consecutive samples with HIV-1 RNA <50 copies/mL by Amplicor from 7 recent clinical trials. HIV-1 RNA results were obtained from the Amplicor and TaqMan 2.0 assays in parallel by a reference laboratory.Results.The overall concordance between assay results was 96% at the cutoff of 50 copies/mL. However, statistically significant discordance at the 50 copies/mL cutoff was found between the assays for 3.9% of samples (n = 87). By TaqMan 2.0, virologic failure defined as HIV-1 RNA ≥50 copies/mL was reported for 2.8% more samples than Amplicor. Of these 87 samples, 68 samples fell within the predicted range of assay variability. Retesting of HIV-1 RNA by TaqMan 2.0 confirmed the discordance in only 28 of the 87 samples.Conclusions.The TaqMan 2.0 assay reports fewer subjects below the clinical endpoint of HIV-1 RNA <50 copies/mL in HIV clinical trials than the Amplicor assay. This difference must be considered when assessing disease progression, designing clinical trials, and comparisons with historical trials that used the Amplicor assay.