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首页> 美国卫生研究院文献>Journal of Clinical Microbiology >Evaluation of the Performance of the Automated NucliSENS easyMAG and EasyQ Systems versus the Roche AmpliPrep-AMPLICOR Combination for High-Throughput Monitoring of Human Immunodeficiency Virus Load
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Evaluation of the Performance of the Automated NucliSENS easyMAG and EasyQ Systems versus the Roche AmpliPrep-AMPLICOR Combination for High-Throughput Monitoring of Human Immunodeficiency Virus Load

机译：自动化NucliSENS easyMAG和EasyQ系统与Roche AmpliPrep-AMPLICOR组合对高通量监测人类免疫缺陷病毒载量的性能评估

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This study presents the data of an evaluation of the automated Nuclisens easyMAG and EasyQ systems versus the Roche AmpliPrep-AMPLICOR combination for testing of high-volume human immunodeficiency virus (HIV) load. This represents a follow-up of a previous study investigating the performance of the real-time Nuclisens assay using the semiautomated NucliSENS miniMAG extraction procedure. Three hundred eighteen patient samples were analyzed using both methods. The easyMAG-EasyQ HIV type 1 system has a higher sensitivity and broader dynamic range than the Cobas AmpliPrep-AMPLICOR system when the standard Roche assay is used alone, 25 to 3,000,000 IU/ml versus 400 to 750,000 HIV RNA copies/ml, respectively. There was significant correlation between the assays (0.93; P < 0.0001), with good accuracy (percent similarity mean μ = 96%), good precision (percent similarity standard deviation = 4.97%), and overall good agreement with a low percent similarity coefficient of variation of 5.17 to 6.11%. Bland-Altman analysis revealed that the AMPLICOR assay generated higher values than the EasyQ combination, with 95% of results within clinically acceptable limits. The throughput of samples was greatly improved using the easyMAG-EasyQ system, allowing 144 samples to be processed within 6 h. The potential for contamination has been dramatically reduced using the automated extraction system. Additional negative controls have been added to the kit to monitor for contamination based on the South African experience. This assay thus presents a real option for monitoring HIV load assays in high-volume testing environments.
机译：这项研究提供了自动化Nuclisens easyMAG和EasyQ系统相对于Roche AmpliPrep-AMPLICOR组合的评估数据，用于测试大量人类免疫缺陷病毒（HIV）负荷。这代表了先前研究的后续研究，该研究使用半自动NucliSENS miniMAG提取程序研究了实时Nuclisens测定的性能。使用这两种方法分析了38个患者样本。当单独使用标准Roche测定法时，easyMAG-EasyQ HIV 1型系统比Cobas AmpliPrep-AMPLICOR系统具有更高的灵敏度和更宽的动态范围，分别为25至3,000,000 IU / ml和400至750,000 HIV RNA拷贝/ ml。分析之间存在显着相关性（0.93; P <0.0001），具有良好的准确度（相似度平均值μ= 96％），良好的精确度（相似度标准偏差百分比= 4.97％）和总体相似度低的相似度变化的5.17％至6.11％。 Bland-Altman分析显示，AMPLICOR分析产生的值高于EasyQ组合，其中95％的结果在临床可接受的范围内。使用easyMAG-EasyQ系统大大提高了样品的通量，可以在6小时内处理144个样品。使用自动提取系统已大大降低了污染的可能性。根据南非的经验，已向试剂盒中添加了其他阴性对照，以监测污染情况。因此，该检测方法为在大容量检测环境中监测HIV负荷检测方法提供了一个真正的选择。

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