美国FDA取消安图生物新冠试剂EUA

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                    <section data-color="rgb(182, 228, 253)" data-custom="rgb(182, 228, 253)"><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section data-color="rgb(182, 228, 253)" data-custom="rgb(182, 228, 253)"><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><p><p><img src="image/20201014/86b79d371e9862b01189f0252a03b2cd_1.jpg" /></p></p></section><section><section><span><strong></strong></span></section><p><span>医疗器械媒体报道先锋</span></p><p><span>分享专业医疗器械知识</span></p></section><section><section><section><span>关注</span></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section><section><br  /></section><p><span>来源：FDA官网、IVD资讯、医业观察</span></p><p><br  /></p><section label="Powered by gulangu" data-role="outer"><section><section data-role="paragraph"><section data-id="94554" data-tools="gulangu"><section data-width="100%"><section><section><section data-autoskip="1"><span>8月7号，FDA官网发布消息，基于对检测试剂准确性的考虑，FDA取消安图生物新冠抗体检测试剂的EUA紧急使用授权。</span></section><section data-autoskip="1"><br  /></section></section></section></section></section><p><span>新冠病毒抗体检测，是一种血清学测试，可以检测一个人是否对SARS-CoV-2有抗体，SARS-CoV-2是导致COVID-19的病毒。</span></p><p><br  /></p><p><p><img src="image/20201014/143b462918ee7b3bf53c05a595e254fe_2.jpg" /></p></p><p><br  /></p><p><span>FDA官网消息来源：</span></p><p><span>https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-august-7-2020</span></p><p><br  /></p><p><span>以下是英文原文：</span></p><p><span>On August 6, the FDA&nbsp;revoked the emergency use authorization (EUA)&nbsp;for Autobio Diagnostics Co., Ltd.’s, Anti-SARS-CoV-2 Rapid Test, a SARS-CoV-2antibody test, due to performance concerns with the accuracy of the test. ACOVID-19 antibody test, also known as a serology test, is a blood test that candetect if a person has antibodies to SARS-CoV-2, the virus that causes COVID-19.</span></p><p><br  /></p><p><span>据了解，安图生物（(603658.SH）新型冠状病毒抗体检测试剂盒（胶体金法）于2020年4月24日获美国食品药品监督管理局（FDA）紧急使用授权（EUA, Emergency Use Authorization），是国内首个获得该授权的新冠病毒抗体检测产品。</span></p><p><br  /></p><p><p><img src="image/20201014/7d33b351bed61ddc063b723029c4c686_3.jpg" /></p></p><p><br  /></p><p><span>此前，在5月7日表示，FDA撤销约60家中国制造商在美国销售N95口罩的EUA授权，理由是这些制造商生产的口罩无法针对新冠病毒提供足够的防护。<br  /></span></p><p><br  /></p><p><span>6月，继对中国口罩企业的过滤效果发难后，对中国口罩企业此前FDA注册的某些不合规，FDA再度出手，认为部分中国口罩企业提供虚假的FDA注册信息。华尔街日报(WSJ)一份分析显示，超过1,300家中国医疗器材公司，在冠状病毒疾病(COVID-19)肆虐期间，据称将德拉瓦州(Delaware)一个实体列为其在美国的代表，但该实体使用的，却是假地址和无人接听的电话号码。</span></p><p><br  /></p><p><span>国内厂家出口美国需谨慎，FDA的事后追责和“长臂管辖”是非常严格的。尤其是在中美关系“脱钩”的当下，更要小心谨慎。目前尚不清楚安图生物新冠试剂EUA取消的原因是否有政治因素的影响，但产品质量一直是企业立足的根本，尤其是关乎生命健康的IVD企业，一定要慎之又慎。</span></p></section></section></section><section><br  /></section><section><section 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