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<section data-role="paragraph" data-color="rgb(182, 228, 253)" data-custom="rgb(182, 228, 253)"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section><p><p><img src="image/20201014/86b79d371e9862b01189f0252a03b2cd_1.png" /></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><p><br /></p><p><span>来源：IVD从业者</span><br /></p><p><br /></p><p><p><img src="image/20201014/98e94abaeaad1b7fe7317e5c742fdc30_2.png" /></p></p><section><br /></section><section><span>2020年1月30日，总干事宣布，2019-nCoV的爆发构成国际关注的公共卫生紧急事件（PHEIC）。世卫组织资格预审小组宣布，<strong>WHO产品紧急使用清单（EUL）</strong>现在将向检测SARS-CoV-2（最初称为2019-nCoV）的候选体外诊断（IVD）厂商开放。</span><br /></section><section><br /></section><section><strong><span>产品紧急使用清单（EUL, Emergency Use Listing）</span></strong><span>类似与国内的产品应急审批快速通道。</span></section><section><br /></section><section><span>2020年2月28日WHO发出邀请，邀请SARS-CoV-2体外诊断制造商提交世卫组织紧急使用清单，并附上了<strong>意向书（EOI）</strong>，文末提供下载。</span></section><section><br /></section><section><span>WHO表示2020年1月30日，总干事宣布由2019年新型冠状病毒引起的COVID-19爆发构成国际关注的<strong>突发公共卫生事件（PHEIC）</strong>。需要有质量，安全和性能有保证的体外诊断试剂，并表示已经有几家检测新冠的产品正在开发中。</span></section><section><span><br /></span></section><section><br /></section><p><p><img src="image/20201014/36d62e6f30ff119455e423710e6d962e_3.png" /></p></p><p><br /></p><section><span>制定<strong>产品紧急使用清单（EUL）</strong>程序是为了加快公共卫生紧急情况下所需诊断试剂的供应。其目的是协助有关采购机构和成员国，能有一套保证最低可用限度的产品。</span></section><section><br /></section><section><span>对于检测SARS-CoV-2的EUL感兴趣的制造商</span><br /><span>可以联系<strong>diagnostics@who.int</strong>安排提交前会议/电话。</span></section><section><span><br /></span></section><section><span>请注意，未经事先与世卫组织协商，申请将不被接受。</span></section><section><br /></section><section><strong><span>目前，申请EUL需要提交以下资料：</span></strong><span></span></section><section><span><br /></span></section><section><span>SARS-CoV-2核酸检测方法的研究</span></section><section><span>详细说明文件证据技术规范的制造商说明见文末附件。</span></section><section><span><br /></span></section><p><p><img src="image/20201014/f7826bac33345f15264899c95d77a6cd_4.png" /></p></p><p><br /></p><section><span>目前，WHO应急通道仅接受<strong>新冠病毒核酸检测试剂的申报</strong>。这也意味着，免疫方法的诊断试剂，目前尚不在WHO应急通道的考虑范围内。</span></section><section><br /></section><section><span>此外，WHO强烈建议试剂厂家参加一个叫<strong>FIND-WHO</strong>的评价计划，该计划即针对新冠病毒的分子诊断试剂。</span></section><section><br /></section><section><span>FIND-WHO研究获得的部分性能和临床证据，可用于<strong>WHO应急申报</strong>。</span></section><section><span><br /></span></section><section><br /></section><p><span><p><img src="image/20201014/a3fee11e56a2c32f2aa0e4ee7d339f06_5.png" /></p></span></p><p><br /></p><section><br /></section><section><span>但要注意的是，<strong>FIND-WHO评价</strong>的内容不能完全满足EUL所需的性能、验证和确认研究要求。因此，参加FIND-WHO不能替代EUL申报（EUL申报也不强制要求试剂厂家参加FIND-WHO）。</span></section><section data-role="paragraph"><p><br /></p></section><section data-tools="gulangu" data-id="85660"><section><section><span>联系方式</span></section><section data-style="white-space: normal; text-align: left;font-size: 14px;line-height: 1.5em; color: rgb(12, 12, 12);"><section><span>联系世卫组织，发送电子邮件至<strong>diagnostics@WHO.int</strong><strong></strong></span></section><section><span>并抄送<strong>stroheru@WHO.int</strong></span></section></section></section></section><p><br /></p><section data-tools="gulangu" data-id="87704"><section><section><section><section data-bcless="darken" data-bclessp="20%" data-width="90%"><br /></section><section><p><span data-brushtype="text">国产试剂的春天</span></p></section></section><section><section data-style="font-size:14px;"><p><span>此次疫情发生在湖北武汉市，据统计一个月研发出的试剂盒已经多达<strong>100余种</strong>，而国家药监局也已经紧急批了<strong>10个</strong>核酸检测试剂，并截止昨日，<strong>之江生物、达安基因和华大基因</strong>已经拿到了<strong>CE</strong>的认证，相信此次WHO的召唤，国内的一种试剂表现也会非常的亮眼，敬请期待。</span></p></section></section></section></section></section><p><br /></p><section><span>点击下方</span><strong><span>阅读原文</span></strong><span>进入<strong>WHO</strong>公告页面。</span></section><p><span></span></p><p><br /></p><section data-role="outer" label="Powered by gulangu"><section data-role="paragraph" data-color="#757576"><section data-role="paragraph"><section><section><section data-brushtype="text"><strong>相关阅读</strong></section></section></section><section><section><br /></section></section><section data-width="100%"><section><section><section><section data-width="100%"><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><section><p><img 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发表于 2020-10-14 12:50:25