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美国FDA批准寨卡病毒分子诊断方法紧急使用授权

2016-03-21 佚名 生物谷

美国食品药品管理局(FDA)(2016年3月18日)宣布它批准一种基于PCR的寨卡病毒测试方法的紧急使用授权(Emergency Use Authorization, EUA)。该方法是由美国疾病控制与预防中心(CDC)开发的。这种Trioplex实时RT-PCT检测方法一次测试便可检测病人样品中是否存在基孔肯雅病毒、登革热病毒和寨卡病毒。寨卡病毒、基孔肯雅病毒和登革热病毒感染的症状是类似的,因此

美国食品药品管理局(FDA)(2016年3月18日)宣布它批准一种基于PCR的寨卡病毒测试方法的紧急使用授权(Emergency Use Authorization, EUA)。该方法是由美国疾病控制与预防中心(CDC)开发的。

这种Trioplex实时RT-PCT检测方法一次测试便可检测病人样品中是否存在基孔肯雅病毒、登革热病毒和寨卡病毒。寨卡病毒、基孔肯雅病毒和登革热病毒感染的症状是类似的,因此利用一种基于PCR的测试方法进行早期检测可能是有利的,而据报道,免疫检测方法往往在这些病原体之间产生交叉反应。

美国CDC在一项声明中说道,将Trioplex测试分销到该监管机构检验室反应网络(Laboratory Response Network, LRN)中的获得认证资格的实验室,这种分销将在接下来的两个星期内开始,但是这种测试将不会提供美国医院或其他的基层医疗机构使用。

本月早些时候,美国卫生与公众服务部(Secretary of Health and Human Services)宣布因存在近期寨卡病毒流行病暴发的情况,批准寨卡病毒检测的体外诊断测试的紧急使用授权是合理的;而且美国CDC开发的一种免疫检测方法是首个被批准紧急使用授权的测试方法。

正如之前报道的那样,美国CDC也将提供一种基于PCR的只检测寨卡病毒的测试方法,以及获得认证资格的执行该监管机构开发的西尼罗河病毒测试或者能够进行寨卡病毒测试的州和地方实验室。

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    2016-08-27 李东泽

    这篇资讯带给我们新知识,启发新思维,不论是科研还是临床工作都有很大的帮助。。。

    0

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    2016-12-05 bugit
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