XTAG™ RVP assay:: analytical and clinical performance
XTAG™ RVP assay:: analytical and clinical performance
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DOI：
10.1016/s1386-6532(07)70009-4
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发表时间：
2007-11-01
影响因子：
8.8
通讯作者：
Janeczko, Richard
中科院分区：
文献类型：
--
作者：
Krunic, Nancy;Yager, Thomas D.;Janeczko, Richard
xTAGTM RVP Assay （RVP）是一种基于多重核酸的分子检测方法，能够在单个患者样本中同时检测20种病毒和亚型。测定方案在本补充的其他地方讨论。本文介绍了该测定法的分析性能和选定的临床结果。xTAG RVP测定的设计要求是在与该领域领先的临床和实验室专家协商后确定的。作为设计验证过程的一部分，xTAGTM RVP检测的临床前测试由Luminex分子诊断公司的研究和产品开发部门进行。随后是一组外部临床前研究，最后是一项多中心临床试验，以获得FDA的批准。总的来说，临床前和临床结果验证了该测定法的性能，符合其规定的设计要求。临床多地点试验仍在进行中，但已接近完成。因此，除了CE标志和FDA提交的分析数据外，临床试验的最终数据摘要不包括在本文中。然而，Mahony等人（2007年）发表了使用临床样本对xTAGTM RVP测定法进行的早期外部评估。值得注意的是，数据来源于FDA临床试验中评估的相同分析，并且两项研究的设计相似。在本增刊出版之前，将提供进一步的检测性能数据。请联系Luminex分子诊断或本文的最后一位作者以获取更多信息。
The xTAGTM RVP Assay (RVP) is a multiplexed nucleicacid based molecular test capable of detecting 20 viruses and subtypes simultaneously in a single patient sample. The assay protocol is discussed elsewhere in this supplement. The present article describes the analytical performance and selected clinical results of this assay. Design requirements for the xTAG RVP Assay were established in consultation with leading clinical and laboratory experts in the field. As part of the design validation process, preclinical testing of the xTAGTM RVP Assay was carried out internally by the Research and Product Development departments at Luminex Molecular Diagnostics. This was followed by an external set of preclinical studies leading up to a multi-centre clinical trial to achieve FDA clearance. Taken together, the preclinical and clinical results validate the performance of the assay against its stated design requirements. The clinical multi-site trial is still ongoing but close to completion. Therefore, the final data summaries of the clinical trial are not included in this article, with the exception of the CE marked and FDA submitted analytical data. However, an earlier external evaluation of the xTAGTM RVP Assay, using clinical samples, was published by Mahony et al.(2007). Of note is the fact that the data are derived from the same assay being evaluated in the FDA clinical trial, and the design of both studies is similar. Further performance data on the assay will be available by the time of publication of this supplement. Please contact Luminex Molecular Diagnostics or the last author of this article for further information.