美国FDA批准了第一个POCT新冠甲流分子联检EUA

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关键词： FDAFDA批准

资讯来源：医业观察

发布时间： 2022-11-25

有观点，有态度

这是医业观察的第1610-5期文章

来源：360dx、IVD工具人

半年前Lucira Health 新冠甲乙流三联检获CE，现在新冠甲乙流的三联检EUA如约而至。

FDA批准Lucira Health的分子COVID-19和流感检测POCT的EUA。FDA表示，该检测是与美国国立卫生研究院独立检测评估项目合作后获得FDA授权的第一种COVID-19分子检测，该项目旨在加快对非处方COVID-19检测的监管审查。

位于加州的Lucira是基于RT-Lamp的一次性的检测试剂，它可以检测SARS-CoV-2病毒RNA，以及甲型和乙型流感病毒RNA，同时区分不同的病毒。该测试使用由医疗保健提供者收集的鼻拭子，可以在POCT使用，非自测产品。

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