[Development of norovirus rapid detection kit "QuickNavi™-Norovirus2"].

Yuji Saito, Daisuke Kato, Koichi Inano
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Abstract

We have evaluated our new Norovirus rapid detection kit "QuickNavi™-Norovirus2" (Denka Seiken Co., Ltd.). The kit is based on Immunochromatographic method using colored latex particles. In addition to simple preparations giving quick (15 min) results, our newly developed kit enables specimen collection directly from rectum and can also be used with neonatal stool samples, both of which cannot be used with the current version of the kit, "QuickNavi™-Norovirus." Clinical study (stool samples, n=172) shows sensitivity, specificity and accuracy of the test compared to RT-PCR are 92.0%, 98.3%, and 94.2%, respectively. The result also showed good correlation with QuickNavi™-Norovirus. In this study, the new Norovirus rapid detection kit has shown sufficient sensitivity and specificity. Their performance, simple preparation enabling rectal swab samples, and quick results can be useful for day to day clinical practice when diagnosing Norovirus infection.

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诺如病毒快速检测试剂盒“QuickNavi™-Norovirus2”的研制
我们已经评估了我们新的诺如病毒快速检测试剂盒“QuickNavi™-Norovirus2”(Denka Seiken Co., Ltd)。该试剂盒是基于免疫层析方法使用彩色乳胶颗粒。除了提供快速(15分钟)结果的简单准备外,我们新开发的试剂盒还可以直接从直肠收集标本,也可以用于新生儿粪便样本,这两种方法都不能与当前版本的试剂盒“QuickNavi™-诺如病毒”一起使用。临床研究(粪便样本,n=172)显示,与RT-PCR相比,该检测的敏感性、特异性和准确性分别为92.0%、98.3%和94.2%。结果显示与QuickNavi™-诺如病毒具有良好的相关性。在本研究中,新型诺如病毒快速检测试剂盒显示出足够的敏感性和特异性。他们的性能,简单的制备使直肠拭子样本,和快速的结果可用于日常临床实践时诊断诺如病毒感染。
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