|
|
<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><a target="_blank" href="https://mp.weixin.qq.com/s?__biz=MzA4NjIwNTQyOA==&mid=2452252645&idx=6&sn=1c4b9c3fb9badebc2e088dc7678c9682&scene=21#wechat_redirect" textvalue="你已选中了添加链接的内容" tab="innerlink" data-linktype="1"><span data-positionback="static"><p><img src="image/20201014/46020d4e3e68caee1c14a1f712f88456_2.png" /></p></span></a></p><p><br /></p><p><span><strong><span>导语：</span></strong></span><span>新冠病毒的肆虐虽然令全人类都遭受苦难，但不得不说，疫情同样是医学科技发展的最好催化剂，还记得今年3月初曾曝出过家用新冠核酸检测试剂盒面世的消息，结果当即遭到了多家媒体的辟谣，而一个多月过去，“家用试剂盒”这一概念已经被FDA承认。</span></p><p><span> </span></p><section><section powered-by="gulangu"><section><section powered-by="gulangu"><section><p><em><strong>家用新冠检测试剂盒获FDA承认</strong></em></p></section></section></section></section></section><p><span></span></p><p><span><br /></span></p><p><span>据外媒报道，美国独立实验室巨头LabCorp公司在4月21日于官网宣布，该公司可在家进行新冠病毒检测的试剂盒（At-Home Test Kit）——<span> "Pixel"</span>，获得了美国食品药品监督管理局（FDA）的紧急使用授权（Emergency Use Authorization）。<strong>如果医疗保健提供者在完成COVID-19调查问卷后提出建议，则允许使用该公司的At-Home Test Kit新冠检测试剂在家中采集鼻拭子样本，送至该公司实验室进行诊断。</strong></span></p><p><span><br /></span></p><p><p><img src="image/20201014/c6676c9bf26ad942bc99dc2cee0b930b_3.png" /></p></p><p><br /></p><p><span>据CNBC报道，LabCorp的检测试剂盒在3月已经获得FDA的紧急使用授权，在4月5日，LabCorp联系FDA，要求修改授权，以允许患者在家中使用该检测试剂盒。</span></p><p><span><br /></span></p><p><span>LabCorp介绍，该试剂盒的价格为</span><span><strong>119美元</strong></span><span>，使用者需被评估为适合使用，并需要在该公司网站上完成一份调查表。该检测试剂盒（At-Home Test Kit）将通过该公司的Pixel by LabCorp平台提供，最初将提供给可能接触过COVID-19或有症状的医护人员和急救人员。并且LabCorp计划在未来几周内扩大至其他美国客户。</span></p><p><span><br /></span></p><p><span>LabCorp表示，该公司目前已有6万个可在家使用的试剂盒，将优先提供给医疗工作者，并有望在未来几周扩大至其他美国客户。</span></p><p><br /></p><p><p><img src="image/20201014/6ad71c7bcebfba33fbfe372035921241_4.jpg" /></p></p><p><br /></p><section><section powered-by="gulangu"><section><section powered-by="gulangu"><section><p><em><strong>家用试剂盒意义及用法</strong></em></p></section></section></section></section></section><p><br /></p><p><span>路透社报道称，美国一直在试图提升检测能力，但由于缺乏专业人员、以及确保安全的个人防护设备，美国扩大检测能力受到一定阻碍。</span></p><p><br /></p><section><span><strong><span>在家收集样本将减少把病毒传染给医务工作者的风险，但也可能存在一些缺点，比如检测者是否正确收集了样本并将其安全送到了实验室</span></strong></span><span>。LabCorp承诺，只要按照试剂盒的说明，患者采集的样品和专业人士采集的样品质量及结果不会有差异。</span></section><section><span><br /></span></section><p><video width="100%" height="580" controls="controls"><source src="http://mpvideo.qpic.cn/0b78miaaaaaafuacom5b2vpfaywdabraaaaa.f10002.mp4?dis_k=16c8543e4193f0acede721857e84d78e&dis_t=1602649643" type="video/mp4"></source></video></p><section><span><span>CNBC对这款试剂盒的报道</span><br /></span></section><section><span><br /></span></section><section><span>家用试剂盒配有棉签，可用于收集鼻样本，还配有生物危害标本袋以及联邦快递的隔夜运输袋，用于将样本邮寄至实验室。实验室在收到样本后一到两天内即可获得结果。</span></section><p><br /></p><p><p><img src="image/20201014/9f1bd304ec6c546c80966b2790be315d_5.png" /></p></p><p><br /></p><p><span><strong><span>结语：</span></strong></span><span>用辩证法来看，尽管"Pixel"有使用方便，减少接触等优势，但也有专家表示，该产品与专业卫生部门进行的冠状病毒的金标准标本采集相比有准确性较差的缺陷。是否能够经得起市场和疫情的考验，我们拭目以待。</span></p><p><br /></p><p><span><strong><span>关于LabCorp</span></strong></span></p><p><br /></p><p><span>LabCorp是一家全球领先的生命科学公司，总部位于美国佛蒙特州伯灵顿，该公司在全球雇佣了近61000名员工，旗下产品包括通过其Pixel系列的结直肠癌、糖尿病和心脏血脂疾病的上门检测，在医学检测领域拥有近50年的经验，LabCorp报告称，2019年收入超过115亿美元。</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 src="image/20201014/2aac877ff9233ba5a66e7a5ff3a4febf_6.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" data-custom="#59c3f9"><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&mid=2652973536&idx=1&sn=e3f118893ea674d44007b9cb72e8b71d&chksm=843f4b77b348c261a5be642e83cc499c0f377443d0ff1b90517e754a781eca311cd63ce3de09&scene=21#wechat_redirect" data-itemshowtype="0" tab="innerlink" data-linktype="2"><span>美国州长：雅培新冠检测产品准确率低！</span></a><br /></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" data-custom="#59c3f9"><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&mid=2652973536&idx=2&sn=65bca7881095973c4839b7755583990e&chksm=843f4b77b348c2617a4262d98e61c2e51660a002e183f2f6fedc85244ece5c6022a2e6b955a2&scene=21#wechat_redirect" data-itemshowtype="0" tab="innerlink" data-linktype="2"><span>你绝对想不到，70亿口罩大单居然被这家企业拿下</span></a><br /></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" data-custom="#59c3f9"><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&mid=2652973517&idx=1&sn=f0847815b6b2f62f0c9ca5dd5dfe488e&chksm=843f4b5ab348c24c15b2ab34c2e16652d9f9211af8cb9ecc1d7b7c4f4788524b488e92bac92c&scene=21#wechat_redirect" data-itemshowtype="0" tab="innerlink" data-linktype="2"><span>两款对抗新冠的“救命神器”全新上线！</span></a><br /></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" data-custom="#59c3f9"><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&mid=2652973517&idx=2&sn=288fa859a44ac51297b2b2e14fc89112&chksm=843f4b5ab348c24c5f9ce147c22cc076e1c9f59a057a8f06ecce49eb2f0f18e5160187a8375c&scene=21#wechat_redirect" data-itemshowtype="0" tab="innerlink" data-linktype="2"><span>飞利浦投资逾1亿欧元，加快呼吸机等抗疫设备生产</span></a><br /></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" data-custom="#59c3f9"><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&mid=2652973502&idx=2&sn=31e7f1a85222bdba4004dabd35bf6352&chksm=843f4b29b348c23f408a2c9904034552ef6364c9dec5c0e2e8b8561f6acbe2002ba57f696006&scene=21#wechat_redirect" data-itemshowtype="0" tab="innerlink" data-linktype="2"><span>世界首创探测人体“哈勃望远镜”落户山东第一医科大学第一附属医院</span></a><br /></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" data-custom="#59c3f9"><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&mid=2652973502&idx=3&sn=25ea180cec36f94e540b7aee997da9d0&chksm=843f4b29b348c23f65710c45a104a29afc159f8ef389ae0d6f1031f67b86c40e87457148e97b&scene=21#wechat_redirect" data-itemshowtype="0" tab="innerlink" data-linktype="2"><span>互联网医疗首次纳入首诊政策，这6省市将率先试点！</span></a><br /></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" data-custom="#59c3f9"><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&mid=2652973460&idx=1&sn=9d5fc2bc50b9d353b2d9ad7f99c73d87&chksm=843f4b03b348c2159553ae7741ac395c3f0470ac8d535e6636667379988a42155442315358e8&scene=21#wechat_redirect" data-itemshowtype="0" tab="innerlink" data-linktype="2" hasload="1">2019中国医疗器械行业企业互联网指数TOP100</a><br /></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" data-custom="#59c3f9"><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&mid=2652973445&idx=2&sn=1800dd94ccc28721aa82a4a769695b29&chksm=843f4b12b348c20481fd8a781bd259bdf52e36f11bcb27be11a052ed269594edefb6c2565386&scene=21#wechat_redirect" data-itemshowtype="0" tab="innerlink" data-linktype="2" hasload="1">强生一季报：医疗器械版块营收下降8.2%！</a></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" data-custom="#59c3f9"><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&mid=2652973445&idx=4&sn=d9e8dd4f6e2989fd0a3f497837d3d532&chksm=843f4b12b348c2049fa50a937ad379a5afa2f031fe5bc2a7607e4baaadc71d0f8c50c91a8a6d&scene=21#wechat_redirect" data-itemshowtype="0" tab="innerlink" data-linktype="2" hasload="1">KN95口罩、核酸检测，FDA不得不认证的国产货！</a></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" data-custom="#59c3f9"><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&mid=2652973438&idx=1&sn=8af2f9ecade3960ed957e72db696e440&chksm=843f4be9b348c2fff154e2b0cf80510c8c6474c85f01e720d87d11505b1b705f99a5e021c501&scene=21#wechat_redirect" data-itemshowtype="0" tab="innerlink" data-linktype="2" hasload="1">“全球最大呼吸机生产厂商”称号易主？通用汽车大规模生产呼吸机！</a></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" data-custom="#59c3f9"><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&mid=2652973438&idx=2&sn=785c568c0c6b5ab489080285b2294ea8&chksm=843f4be9b348c2ff76fd0fb2ca08e3eaaadc7cb3260721662a32753e2e5744353ec77585fec5&scene=21#wechat_redirect" data-itemshowtype="0" tab="innerlink" data-linktype="2" hasload="1">CMEF官方通告，开展时间再次延后！</a><br /></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" data-custom="#59c3f9"><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&mid=2652973409&idx=1&sn=bd0872284fb6bb6a46a8eb976947ef38&chksm=843f4bf6b348c2e0f008fca443a57600ef9134ddd4f737d76ad1948ca929e8eb87eb09654cc8&scene=21#wechat_redirect" data-itemshowtype="0" tab="innerlink" data-linktype="2" hasload="1">手持式超声Accuro通过FDA认证！</a><br /></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" data-custom="#59c3f9"><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&mid=2652973409&idx=2&sn=729e218041eda766a7abf99f1e0457e6&chksm=843f4bf6b348c2e0e53833c84f5e23909daa30791ed9f0c29bca4cd2ad74ce3ca1c97f4ca2c7&scene=21#wechat_redirect" data-itemshowtype="0" tab="innerlink" data-linktype="2" hasload="1">准确率100%&nbsp;！美国首次批准用唾液检测新冠!</a><br /></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" data-custom="#59c3f9"><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&mid=2652973396&idx=1&sn=2ce08f5be0e7d7cf4f6a8fc57337fc52&chksm=843f4bc3b348c2d55c18807eba99e0d647b9907660858e0d29bd1d79cd8fa892bc0665e8826a&scene=21#wechat_redirect" data-itemshowtype="0" tab="innerlink" data-linktype="2" hasload="1">国内手术机器人第一股登录科创板！</a><br /></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" data-custom="#59c3f9"><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&mid=2652973396&idx=2&sn=cd6c4fa7bcb555a7c096a0394fc6628c&chksm=843f4bc3b348c2d51ec8f45f9f2f8ff3f9dff7f418c62b0576d211944e13d7dc3771c9068374&scene=21#wechat_redirect" data-itemshowtype="0" tab="innerlink" data-linktype="2" hasload="1">九例不良事件！波士顿科学血管造影导管面临一级召回！</a><br /></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" data-custom="#59c3f9"><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&mid=2652973378&idx=1&sn=254236d1bd523f5c2b7620349a790dfb&chksm=843f4bd5b348c2c3a540c95c94957d710184abcdd1737155b6d83fbcf075c7ab7ab16f884ef7&scene=21#wechat_redirect" data-itemshowtype="0" tab="innerlink" data-linktype="2" hasload="1">原厂上百万的球管，非原厂品牌不到一半，医院该如何选？</a><br /></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" data-custom="#59c3f9"><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&mid=2652973378&idx=2&sn=493434a83c06c2bc4c5231589c969aab&chksm=843f4bd5b348c2c3179968c3588fb4dde0b4b2563b6adbdfe099bc9299acd1b53cb63aaa43e4&scene=21#wechat_redirect" data-itemshowtype="0" tab="innerlink" data-linktype="2" hasload="1">3D打印巨头研发简易呼吸机对抗疫情</a><br /></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" data-custom="#59c3f9"><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&mid=2652973372&idx=1&sn=8216dd274f473dfe03bec5ac22614296&chksm=843f4babb348c2bd971ff245f3ca631161ffa43e991ee1877fb9c410974bb3eecfd939015ef6&scene=21#wechat_redirect" data-itemshowtype="0" tab="innerlink" data-linktype="2" hasload="1">丛林法则下的器械维修路在何方？</a><br /></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" data-custom="#59c3f9"><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&mid=2652973344&idx=1&sn=ce3d2268858a4314eaf62ff26937b513&chksm=843f4bb7b348c2a1d07fc4ed4e43ba287460d6b4e669cd5232ca193ee483e5e57aa18b20d043&scene=21#wechat_redirect" data-itemshowtype="0" tab="innerlink" data-linktype="2" hasload="1">2.8亿，美敦力业务被国内械企收购！</a><br /></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" data-custom="#59c3f9"><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&mid=2652973295&idx=1&sn=5d8c86cd46631de6c4f98609f6cfd507&chksm=843f4a78b348c36eb25d2b8ca6a37b85f6e9f2ecad5d7fd3119820b1b917a80ec0f90ed28a92&scene=21#wechat_redirect" data-itemshowtype="0" tab="innerlink" data-linktype="2" hasload="1">获得施乐投资的一次性呼吸机——GO2Vent有何过人之处？</a></section></section></section></section></section></section></section></section></section><p><br /></p><p><p><img src="image/20201014/aad9f56b0707b5374bbac6273a663447_7.jpg" /></p></p>
|
|
发表于 2020-10-14 12:27:23