Abstract The Luminex® NxTAG® Respiratory Pathogen Panel (NxTAG RPP) is an IVD-cleared assay for the simultaneous detection and identification of nucleic acids from 18 respiratory viruses and 2 (or 3 outside of the U.S.) atypical bacterial pathogens in nasopharyngeal swabs. Its scalability allows concurrent testing of up to 96 samples in a single batch. Nucleic acid extracted from 200 µL of raw specimen using the easyMAG® extractor is added directly to pre-plated, lyophilized bead reagents (LBRs), where multiplexed RT-PCR and hybridization to MagPlex-TAG™ microspheres occurs within a sealed reaction well using a single cycling program. Data acquisition is done on the MAGPIX® instrument which reads and sorts the reaction products directly from the sealed well following transfer of the assay plate from the thermal cycler. NxTAG is the newest innovation in bead-based nucleic acid chemistry developed by Luminex. Here we provide the detailed assay protocol and present data which describe the clinical and analytical performance characteristics of NxTAG RPP.

中文翻译：

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使用 NxTAG® 呼吸道病原体面板多重检测和鉴定呼吸道病原体

摘要 Luminex® NxTAG® 呼吸道病原体检测试剂盒 (NxTAG RPP) 是一种经 IVD 清除的检测方法，用于同时检测和鉴定鼻咽拭子中 18 种呼吸道病毒和 2 种（或美国以外的 3 种）非典型细菌病原体的核酸。其可扩展性允许在单个批次中同时测试多达 96 个样本。使用 easyMAG® 提取器从 200 µL 原始样本中提取的核酸直接添加到预镀的冻干珠试剂 (LBR) 中，其中多重 RT-PCR 和与 MagPlex-TAG™ 微球的杂交发生在密封反应孔内，使用单人骑行计划。数据采集​​在 MAGPIX® 仪器上完成，该仪器在检测板从热循环仪转移后直接从密封孔中读取和分类反应产物。NxTAG 是 Luminex 开发的基于珠的核酸化学的最新创新。在这里，我们提供了详细的检测方案并提供了描述 NxTAG RPP 的临床和分析性能特征的数据。