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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><section data-role="paragraph" data-color="rgb(182, 228, 253)" data-custom="rgb(182, 228, 253)"><section><br /></section><section><section powered-by="gulangu"><section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><br /></section></section></section></section></section><section powered-by="gulangu"><section><br /></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><br /></section></section></section><section><section powered-by="gulangu"><section><br /></section></section></section></section></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><p><span>●</span> 全新Elecsys Anti-SARS-CoV-2血清检测支持检测曾暴露于可导致COVID-19的SARS-CoV-2病毒的患者体内的病毒抗体</p><p><br /></p><p><span>●</span><span> </span>对这些抗体的检测能够提示受试者是否已获得对该病毒的免疫力，并指导治疗决策</p><p><br /></p><p><span>●</span><span> </span>罗氏计划于五月初在接受CE标识的国家推出该检测<span><sup><span lang="EN-US">1</span></sup></span>，并正积极与美国食品药品监督管理局合作以获得紧急使用授权（EUA）<span><sup><span lang="EN-US">2</span></sup></span></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><section><svg viewbox="0 0 1 1"></svg></section></section><section><section powered-by="gulangu"><section><br /></section></section></section></section></section><section powered-by="gulangu"><section><br /></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><br /></section></section></section><section><section powered-by="gulangu"><section><br /></section></section></section></section></section></section></section></section></section><p><br /></p><p><span>2020年4月17日，罗氏宣布其研制的Elecsys</span><sup></sup><span> Anti-SARS-CoV-2血清检测即将上市，用于检测曾暴露于可导致COVID-19的SARS-CoV-2患者体内的病毒抗体。</span><br /></p><p><br /></p></section><section powered-by="gulangu"><p><p><img src="image/20201014/6f79b672daf9fbc9e9076bfd0d71eff4_2.jpg" /></p></p><p><br /></p></section><section powered-by="gulangu"><p><span>抗体检测是帮助识别病毒感染者的关键，尤其是对于无症状感染者3。此外，该检测能为高风险人群的优先筛查提供支持，例如医疗工作者、食品供应人员等可能已在一定程度上获得免疫，可继续提供服务和/或恢复工作。随着对COVID-19免疫了解的加深，该检测将助力社会尽快恢复正常运作。</span></p><p><br /></p><p><br /></p><section><section powered-by="gulangu"><section><section powered-by="gulangu"><section><br /></section></section></section><section><section powered-by="gulangu"><section><p><span><strong><em><span>Severin Schwan</span></em></strong></span></p></section></section><section powered-by="gulangu"><section><p>罗氏集团首席执行官</p></section></section></section><section><section powered-by="gulangu"><section><br /></section></section></section></section><section powered-by="gulangu"><section><section><span>“</span> <section><section><svg viewbox="0 0 1 1"></svg></section></section></section><section><section powered-by="gulangu"><p>紧随三月中旬推出的用于检测该疾病病毒活性的高通量PCR检测，罗氏现将于五月初推出一款全新抗体检测。市场上每一款可靠的检测都有助于医疗系统对抗疫情。罗氏正与卫生当局紧密协作，扩大生产，以确保在全球范围内快速获得该检测。</p></section></section><section><section><section><svg viewbox="0 0 1 1"></svg></section></section><span>”</span></section></section></section><section powered-by="gulangu"><p><br /></p><p><br /></p></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section><br /></section></section></section><section><section powered-by="gulangu"><section><p><span><strong><em><span>Thomas Schinecker</span></em></strong></span></p></section></section><section powered-by="gulangu"><section><p>罗氏诊断首席执行官</p></section></section></section><section><section powered-by="gulangu"><section><br /></section></section></section></section><section powered-by="gulangu"><section><section><span>“</span> <section><section><svg viewbox="0 0 1 1"></svg></section></section></section><section><section powered-by="gulangu"><p>罗氏坚定地致力于支持全球应对COVID-19疫情。<span>及时、快速地获得可靠、高质量的检测对医疗系统至关重要。抗体检测是抵御COVID-19的重要下一步。罗氏抗体检测可以迅速扩大规模，并在世界各地广泛应用，因为我们仪器设备已经安装就位。</span></p></section></section><section><section><section><svg viewbox="0 0 1 1"></svg></section></section><span>”</span></section></section></section></section><p><br /></p></section><section powered-by="gulangu"><p><span>Elecsys Anti-SARS-CoV-2免疫检测是一种从人体血液样本中提取血清和血浆来检测抗体、并确定人体对SARS-CoV-2免疫反应的一种体外检测。该检测可用于流行病学研究，以此来帮助更好地了解疾病的传播。该检测还可与分子检测共同使用，以助力对疑似COVID-19患者的诊断。医院和参考实验室可以在罗氏cobas e分析仪上开展该检测，该系列分析仪在全球实验室中广泛应用。</span></p><p><br /></p></section><section powered-by="gulangu"><p><p><img src="image/20201014/8c67fb1f9e0c9d727563b0259c1bf5e0_3.jpg" /></p></p><p><br /></p></section><section powered-by="gulangu"><p><span>据悉，罗氏计划于5月初在接受CE标识的国家推出该抗体检测，并正积极与FDA合作以获得紧急使用授权。罗氏正计划加快每月产能，争取在6月达到近亿次的产量，并将进一步尽最快速度提升产能规模。</span></p><p><br /></p></section><section powered-by="gulangu"><p><br /></p></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section powered-by="gulangu"><section><section powered-by="gulangu"><section><p><br /></p></section></section></section></section></section></section></section><section><section powered-by="gulangu"><p>关于SARS-CoV-2（冠状病毒）</p></section></section></section></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section><section powered-by="gulangu"><section><p><span>冠状病毒（CoV）是个庞大的病毒家族，可引起从普通感冒到更严重疾病等各种病症，例如中东呼吸综合征（MERS-CoV）和严重急性呼吸综合征（SARS-CoV）。SAR-CoV-2是一种未曾在人类中发现的新型病毒株。<br /></span></p><p><br /></p><p><span>感染体征包括呼吸道症状，例如咳嗽、呼吸短促、呼吸困难和发热。在更严重的病例中，可出现肺炎、严重急性呼吸综合征、肾衰竭和死亡。</span></p><p><br /></p><p><span>为了控制感染的传播，WHO建议勤洗手、咳嗽和打喷嚏时捂住口鼻、彻底煮熟肉类和鸡蛋、避免与出现呼吸系统疾病症状的人近距离接触。</span></p><p><span><br /></span></p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section powered-by="gulangu"><section><section powered-by="gulangu"><section><p><br /></p></section></section></section></section></section></section></section><section><section powered-by="gulangu"><p>关于Elecsys Anti-SARS-CoV-2血清学检测</p></section></section></section></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section><section powered-by="gulangu"><section><p><span>Elecsys</span><span><sup></sup></span><span> Anti-SARS-CoV-2检测是一款用于在人体血清及血浆中进行SARS-CoV-2抗体（包括IgG）体外检测的免疫检测。该检测可通过血液样本检测到冠状病毒的抗体，这可能提示受试者是否已感染了这种病毒并可能对这种病毒产生了免疫力。医院和参考实验室可以在世界各地广泛使用的罗氏cobas e分析仪上开展检测。这些全自动系统可以在18分钟左右内提供SARS-CoV-2检测结果，每小时检测通量可达300次，视不同型号仪器</span><span><sup>4</sup></span><span>而定。</span></p></section></section></section></section></section></section></section></section></section><p><br /></p><p><span>参考文献：<br /></span></p><p><span>[1] CE-IVD markingis granted through completion of a comprehensive technical validation andself declaration under the European Directive for In Vitro Diagnostic MedicalDevices.</span></p><p><span>[2] The Emergency Use Authorisation (EUA) authority allowsFDA to help strengthen the nation’s public health protections against CBRNthreats by facilitating the availability and use of medical countermeasuresneeded during public health emergencieshttps://www.fda.gov/home</span></p><p><span>[3]Thus, 29 of the 33 patients who were positive forSARS-CoV-2 at admission (87.9%) had no symptoms of Covid-19 at presentation -https://www.nejm.org/doi/full/10.1056/NEJMc2009316</span></p><p><span>[4] Full specificationsof the Roche immunoassay systems, including throughput, can be found on our diagnostics.roche website </span></p><section><br /></section><section><span>来源：罗氏诊断</span></section><section><br /></section></section><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 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发表于 2020-10-14 12:29:08