8家9款，新冠快速检测产品应急申报名单

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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：</span><span>&nbsp;IVD从业者&nbsp; &nbsp;作者：</span><span>锁炎&nbsp;</span></p><p><br  /></p><section data-role="paragraph"><p><span>2月8日，国家科技部发布《新型冠状病毒（2019-nCoV）现场快速检测产品研发应急项目申报指南》拉开了关于新型冠状病毒现场快速检测市场的帷幕。</span></p><p><br  /></p><p><span>本次应急产品审批主要突出“现场快速检测的应急需求、结果导向，围绕疑似患者的快速诊断和密切接触人群的现场筛查”。</span></p><p><br  /></p><p><span>指南一共提及了三种类型的产品，2月19日，据可靠消息称，国家已从申报的300多种产品中筛选出了9个产品报送药监局紧急审批。</span></p><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><strong>核酸快检设备及试剂</strong></p></section></section><section><section data-style="font-size:14px;"><p><span>研发目的：</span><span>为患者确诊提供现场快速检测手段，缓解目前患者确诊的检测压力。</span></p><p><br  /></p><p><span>考核指标：</span><span>单独闭管进行核酸提取与扩增检测一体化，实现“样本进，结果出”的现场快速检测，解决“开盖”问题，全流程检测时长不超过1.5小时；</span><span>分析灵敏度达到300拷贝/毫升以下，与传统实时荧光PCR试剂相比，检出率（灵敏度）要不低于95%，特异度不低于99%，可涵盖因变异导致的检测假阴性。</span></p><p><br  /></p><p><span>本次获得推荐的核酸项目为：</span></p></section></section></section></section></section><section data-tools="gulangu" data-id="93819"><section><section data-width="100%"><section data-width="100%"><section data-width="100%"><section><section><section><section><section><section data-brushtype="text"><span>C:</span></section></section><section data-brushtype="text"><p><span><strong>杭州优思达生物技术有限公司</strong><strong></strong></span></p></section></section><section><section><br  /></section></section><section><section><section data-brushtype="text"><span>P</span></section></section><section data-autoskip="1"><p><span>新型冠状病毒（2019-nCoV）核酸现场快速检测设备及试剂</span></p></section></section></section></section></section></section></section></section><section data-width="100%"><section data-width="100%"><br  /></section></section></section></section><section data-tools="gulangu" data-id="93819"><section><section data-width="100%"><section data-width="100%"><section data-width="100%"><section><section><section><section><section><section data-brushtype="text"><span>C:</span></section></section><section data-brushtype="text"><p><span><strong>上海仁度生物科技有限公司</strong><strong></strong></span></p></section></section><section><section><br  /></section></section><section><section><section data-brushtype="text"><span>P</span></section></section><section data-autoskip="1"><p><span>全自动、高通量、现场快速新型冠状病毒核酸检测系统</span></p></section></section></section></section></section></section></section></section><section data-width="100%"><section data-width="100%"><br  /></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><strong>抗原快速检测试剂</strong></p></section></section><section><section data-style="font-size:14px;"><p><span>研发目的：</span><span>为疑似患者排查和无症状感染者筛查提供不依赖于设备（场所）、更快速的现场检测手段。</span></p><p><br  /></p><p><span>考核指标：</span><span>全流程检测时长不超过30分钟。</span><span>抗原试剂在临床患者中的检出率可达到核酸检测的80%以上，与常见感染人的冠状病毒无显著交叉。</span></p><p><br  /></p><p><span>本次获得推荐的抗原检测项目为：</span><span><strong><span></span></strong></span></p></section></section></section></section></section><section data-tools="gulangu" data-id="93819"><section><section data-width="100%"><section data-width="100%"><section data-width="100%"><section><section><section><section><section><section data-brushtype="text"><span>C:</span></section></section><section data-brushtype="text"><p><span><strong>广州万孚生物技术股份有限公司</strong><strong></strong></span></p></section></section><section><section><br  /></section></section><section><section><section data-brushtype="text"><span>P:</span></section></section><section data-autoskip="1"><p><span>适宜于疫情现场的新型冠状病毒抗原快速检测试剂开发项目</span></p></section></section></section></section></section></section></section></section><section data-width="100%"><section data-width="100%"><br  /></section></section></section></section><section data-tools="gulangu" data-id="93819"><section><section data-width="100%"><section data-width="100%"><section data-width="100%"><section><section><section><section><section><section data-brushtype="text"><span>C:</span></section></section><section data-brushtype="text"><p><span><strong>北京华科泰生物技术股份有限公司</strong><strong></strong></span></p></section></section><section><section><br  /></section></section><section><section><section data-brushtype="text"><span>P:</span></section></section><section data-autoskip="1"><p><span>新型冠状病毒肺炎抗原检测系统的研发项目</span></p></section></section></section></section></section></section></section></section><section data-width="100%"><section data-width="100%"><br  /></section></section></section></section><section data-tools="gulangu" data-id="93819"><section><section data-width="100%"><section data-width="100%"><section data-width="100%"><section><section><section><section><section><section data-brushtype="text"><span>C:</span></section></section><section data-brushtype="text"><p><span><strong>北京金沃夫生物工程科技有限公司</strong><strong></strong></span></p></section></section><section><section><br  /></section></section><section><section><section data-brushtype="text"><span>P:</span></section></section><section data-autoskip="1"><p><span>新型冠状病毒（2019-nCoV）抗原检测试剂盒的研究开发项目</span></p></section></section></section></section></section></section></section></section><section data-width="100%"><section data-width="100%"><br  /></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><strong>抗体快速检测试剂</strong><strong></strong></span></p></section></section><section><section data-style="font-size:14px;"><p><span>研发目的：</span><span>为疑似患者排查提供血液样本的现场快速和高通量快速检测手段。</span></p><p><br  /></p><p><span>考核指标：</span><span>现场快速检测试剂可以检测全血，全流程检测时长不超过30分钟。</span><span>IgM抗体试剂在临床患者中检出率超过70%，IgG抗体/总抗体试剂在恢复期患者中检出率超过90%，与常见冠状病毒感染患者血清无明显交叉。</span></p><p><br  /></p><p><span>本次获得推荐的抗体检测项目为：</span></p></section></section></section></section></section><section data-tools="gulangu" data-id="93819"><section><section data-width="100%"><section data-width="100%"><section data-width="100%"><section><section><section><section><section><section data-brushtype="text"><span>C:</span></section></section><section data-brushtype="text"><p><span><strong>广东和信健康科技有限公司</strong><strong></strong></span></p></section></section><section><section><br  /></section></section><section><section><section data-brushtype="text"><span>P:</span></section></section><section data-autoskip="1"><p><span>新型冠状病毒现场快速诊断试剂</span></p></section></section></section></section></section></section></section></section><section data-width="100%"><section data-width="100%"><br  /></section></section></section></section><section data-tools="gulangu" data-id="93819"><section><section data-width="100%"><section data-width="100%"><section data-width="100%"><section><section><section><section><section><section data-brushtype="text"><span>C:</span></section></section><section data-brushtype="text"><p><span><strong>北京万泰生物药业股份有限公司</strong><strong></strong></span></p></section></section><section><section><br  /></section></section><section><section><section data-brushtype="text"><span>P:</span></section></section><section data-autoskip="1"><p><span>新型冠状病毒（2019-nCoV）抗体快速检测试剂盒的研制项目</span></p></section></section></section></section></section></section></section></section><section data-width="100%"><section data-width="100%"><br  /></section></section></section></section><section data-tools="gulangu" data-id="93819"><section><section data-width="100%"><section data-width="100%"><section data-width="100%"><section><section><section><section><section><section data-brushtype="text"><span>C:</span></section></section><section data-brushtype="text"><p><span><strong>广州万孚生物技术股份有限公司</strong><strong></strong></span></p></section></section><section><section><br  /></section></section><section><section><section data-brushtype="text"><span>P:</span></section></section><section data-autoskip="1"><p><span>基于荧光微球/胶体金免疫层析技术的新型冠状病毒抗体快速检测试剂开发项目</span></p></section></section></section></section></section></section></section></section><section data-width="100%"><section data-width="100%"><br  /></section></section></section></section><section data-tools="gulangu" data-id="93819"><section><section data-width="100%"><section data-width="100%"><section data-width="100%"><section><section><section><section><section><section data-brushtype="text"><span>C:</span></section></section><section data-brushtype="text"><p><span><strong>英诺特（唐山）生物技术有限公司</strong><strong></strong></span></p></section></section><section><section><br  /></section></section><section><section><section data-brushtype="text"><span>P:</span></section></section><section data-autoskip="1"><p><span>2019-<span>新型冠状病毒</span>IgM/IgG<span>联合检测试剂盒（胶体金法）</span></span></p></section></section></section></section></section></section></section></section><section data-width="100%"><section data-width="100%"><br  /></section></section></section></section><p><br  /></p><p><p><img src="image/20201014/74aaf92633e3890d582e812a864d1902_2.jpg" /></p></p><p><br  /></p></section><section data-tools="gulangu" data-id="85660"><section><section data-style="white-space: normal; text-align: left;font-size: 14px;line-height: 1.5em; color: rgb(12, 12, 12);"><p><span>本次项目由国务院应对新冠肺炎疫情联防联控机制科研攻关办公室及国家科技部组织评审，并向国家药监局报送审批，推荐上述产品纳入药监局应急审批通道，暂无明确消息证明已进入快速审批通道。</span></p><p><br  /></p><p><span>本文信息仅供参考，具体应以科技部、药监局官方通告为准。</span></p></section></section></section><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 src="image/20201014/2aac877ff9233ba5a66e7a5ff3a4febf_3.gif" /></p></section><section data-brushtype="text">戳一下，更有料！</section></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" 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