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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><strong><span>导语：</span></strong></span><span>在新冠疫情爆发后，雅培凭借在IVD领域的多年耕耘，迅速产出了多种针对新冠疫情的解决方案，因为其中包括备受关注的5分钟即可出结果的核酸检测仪器ID NOW被誉为新冠核酸检测的“领导者”，然而近日却因为准确率问题，被白宫质疑。</span></p><section><br /></section><section powered-by="gulangu"><p><p><img src="image/20201014/fb0d6924f05175f1d80b362ed18c4d90_2.jpg" /></p></p><p><br /></p><p><span><strong><span>4种新冠检测产品，奠定行业地位<br /></span></strong></span></p><p><br /></p><p><span>据外媒报道，雅培前后开发了4种新冠检测产品，其中最负盛名的应该是ID NOW，该产品号称可在3-5分钟出结果，准确率达99%。</span></p><p><br /></p><p><p><img src="image/20201014/668aa73c25475939016c842196b537dc_3.jpg" /></p></p><p><br /></p><p><span>其实严格来讲，ID NOW不算是新技术。ID NOW的原理基于NEAR(Nicking enzyme amplification reaction，切口酶扩增反应技术)。NEAR是 Ionian Technologies Inc. 的技术， Ionian是加州的初创公司，成立于2000年，和下面TwistDx Inc. (1999年在麻省剑桥)很接近，两者又都在2010年被Alere收购。而后Alere在2017年被雅培收购，NEAR技术自此成为雅培的专利。</span></p><p><br /></p><p><span>Nicking Enzyme 或者叫 Nicking endonuclease, 中文名叫切口酶或者缺口酶 。与常见的核酸内切酶不同的是，切口酶识别特定序列以后只切开一条链。从病毒核酸序列上切下特定短序列(8-16个碱基)的单链以后，利用恒温扩增的DNA聚合酶（isothermal amplification chemistry 专利中未具体描述）。又因为温度保持在60℃左右，合成的短序列自动解旋成为两个单链，于是这两个单链又分别作为恒温扩增酶的模板进一步扩增。</span></p><p><br /></p><p><span>在短时间内，只要原料和能量充足，这个扩增反应是指数速率的。而且由于不需要经过升温和降温的过程，相比传统的PCR过程，速度上的优势是肉眼可见的。</span></p><p><br /></p><p><span>新合成的短序列单链之后与带有荧光的引物结合，从而通过荧光来定量分析。当荧光达到一定强度，认定相应的病毒DNA达到一定含量，认定为阳性。ID NOW设定的阈值是5分钟观察，5分钟如果达到阈值，则报告为阳性；如果5分钟未达到，则继续观察，在13分钟前达到阈值，也报告为阳性；13分钟时仍未到达阈值的，报告为阴性。</span></p><p><br /></p><p><span>与ID NOW同时在3月底推出的另一项用于实验室设备M2000。此外雅培还启动了一项基于实验室的血清学测试，以检测抗体IgG，据悉，雅培还将在近期启动新一轮抗体实验。通过抗体检测，医护人员能够获取针对新冠病毒的更多信息，包括抗体在体内停留的时间以及是否能够提供免疫力，用于帮助开展治疗与疫苗研发。雅培计划在4月份进行400万次IgG抗体检测，6月份及以后有能力增加到2000万次/每月。</span></p><p><br /></p><p><p><img src="image/20201014/dc22937cd7a00ba2356ed8a939c2eccc_4.jpg" /></p></p><p><br /></p><p><span><strong><span>白宫质疑雅培核酸检测产品准确性<br /></span></strong></span></p><p><br /></p><p><span>据全球最大的全球最大的财经资讯公司彭博新闻社报道，在近期白宫的一次新冠疫情简报会上展示了包括雅培ID NOW在内的四款不同类型、不同效率的新冠检测设备，并发布了各界对其评价。</span></p><p><span><br /></span></p><p><p><img src="image/20201014/eaf45b98466f810b0e8dfdbb5375d675_5.jpg" /></p></p><p><span>贾里德·波利斯（Jared Polis）</span></p><p><span><br /></span></p><p><span>其中科罗拉多州州长贾里德·波利斯（Jared Polis）评价雅培的ID NOW“人们普遍认为它的准确率较低”。而从技术角度来看，基于NEAR<span>技术的检测方式相比其他的核酸检测方法，虽有速度和灵敏度的优势，但短序列的设计确实存在高假阳性的可能，或许未来我们能看到升级版的ID NOW能够更好的解决假阳性的问题。</span></span></p><p><span><br /></span></p><p><span><strong><span>结语：</span></strong></span><span>虽然存在着不和谐的声音，但目前雅培仍有<span>三款新冠检测试剂在美上市，第四款或许也很快就能与我们见面。日前<span>雅培发布了2020年Q1财报，全球销售额为77.26亿美元，上年同期为75.35亿美元。净利润为5.64亿美元，上年同期为6.72亿美元。其中，医疗设备业务销售额29.37亿美元，营养业务销售额19.04亿美元，诊断业务销售额18.26亿美元，制药业务销售额10.44亿美元。</span></span></span></p><p><br /></p><p><span>参考来源：国外媒体报道、知乎 胡汉三又回来了</span></p><p><span></span></p><p><span><br /></span></p></section><section data-role="outer" 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发表于 2020-10-14 12:27:41