顶级期刊新英格兰杂志编辑发文：新冠核酸、总抗体联合检测，敏感性高达99.4%！

admin · 发表于 2020-10-14 12:24:11

                  <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><section><section><section><section data-width="100%"><p><img src="image/20201014/8beb37d0f3c5e8dcf18c495191b632f3_2.png" /></p></section><section data-width="100%"><br  /></section></section></section><section><section data-autoskip="1"><p><span>3月31日，新英格兰编辑Mary教授在《NEJM Journal Watch》上发表关于新冠血清学检测研究的最新评论：“新冠血清学抗体检测可以辅助病毒感染诊断和管理、提供机体免疫反应动力学信息。”</span></p></section></section></section><section><br  /></section><section><p><img src="image/20201014/2d5a71c46293592951406f33bba7ff32_3.png" /></p></section><section><span> </span></section><p><strong><span>在评论中，Mary教授提到：</span></strong><span>血清学抗体检查可提高新冠的早期检出率。由于核酸检测假阴性高，抗体检测将是核酸检测的有益补充。同时，新冠疫苗筛选也需要血清抗体检测实验，用于绘制群体免疫的反应水平。</span></p><p><br  /></p><section><br  /></section><p><p><img src="image/20201014/0fbbcbba6663600999363fb0777c7ffd_4.png" /></p></p><section><br  /></section><section><span>文中阐述了厦门大学和深圳三院等基于万泰生物新冠抗体试剂做出的相关研究。“赵等人在深圳三院利用万泰生物新冠总抗体（Ab）、IgM 抗体和 IgG 抗体试剂检测了 173 例核酸确诊的患者血清。</span></section><section><span><br  /></span></section><section data-tools="gulangu" data-id="97170"><section><section><br  /></section><section><section><section data-brushtype="text"><strong>结果表明：</strong></section></section><section data-bdless="spin" data-bdlessp="280"><br  /></section></section><section><section><section data-autoskip="1"><p><span>发病7天内样本PCR阳性率为66.7%，抗体阳性率为38.3%。发病第2周，PCR 和抗体检测阳性率分别为 54.0%和 89.6%。PCR和抗体联合检测可提高不同感染阶段新冠的检出率，且总抗体检测比IgM或IgG抗体检测灵敏度更高。”</span></p></section></section></section></section></section><p><br  /></p><p><span>该篇文章于3月2日发表在medRxiv预印本上，题目为Antibody responses to SARS-CoV-2 in patients of novel coronavirus disease 2019。</span></p><p><br  /></p><p><span>研究对173名COVID -19确诊患者的SARS-CoV-2总抗体（Ab）、IgM 抗体和 IgG 抗体以及核酸进行检测，结果表明新冠总抗体Ab、IgM和IgG的阳性检出率分别为93.1%（161/173）、82.7%（143/173）和64.7%（112/173），总抗体检出率最高。</span></p><p><br  /></p><p><strong><span>在总抗体与核酸联合检测的应用上，研究表明：</span></strong><span></span></p><p><span> </span></p><section data-tools="gulangu" data-id="97269"><section><section><p><span><strong>一、新冠核酸、总抗体联合检测，敏感性高达99.4%</strong></span></p></section><section><section><br  /></section><section><p><img src="image/20201014/cee006e9aa6f22cf69a9e48a6d9981ed_5.png" /></p></section><section><br  /></section></section></section></section><p><br  /></p><p><span>实验发现，173名确诊样本中单独采用 RNA 检测新冠的灵敏度仅为 67.1%，而联合血清总抗体检测敏感性可高达99.4%，较单独核酸检测检出率提升 32.3%。</span></p><section><span> </span></section><p><p><img src="image/20201014/47fbf9d49fa2a6f129ad80d1e46de998_6.png" /></p></p><section><br  /></section><section data-tools="gulangu" data-id="97269"><section><section><p><span><strong>二、不同病程阶段，新冠总抗体均表现出良好的互补作用</strong></span></p></section><section><section><br  /></section><section><p><img src="image/20201014/cee006e9aa6f22cf69a9e48a6d9981ed_5.png" /></p></section><section><br  /></section></section></section></section><p><br  /></p><p><span>研究分析了自发病后不同病程阶段RNA和抗体联合检测的敏感性。结果表明即使在发病早期（就诊后 1～7d），联合检测的灵敏度可达78.7% ，相比 RNA单独检测（66.7%），灵敏度提高了12.0%。<strong>值得一提的是，在发病15-39天的样本中核酸的检出率仅为45.5%，而与总抗体联合检测，可实现100%检出</strong>。</span></p><p><br  /></p><p><span>进一步的分析表明，自发病以来的第1-3天，第4-7天，第8-14天和第15-39天收集的呼吸道样品中检测不到RNA的患者中，有28.6％（2/7），53.6％（15/28），98.2％（56/57）和100％（30/30）的患者可用总抗体检出（表3）。RNA和总抗体的联合使用，显著提高了COVID-19患者在不同疾病阶段的检出率。</span></p><p><br  /></p><p><p><img src="image/20201014/82bedca170fbe273c6bfbd564c9b5eff_8.png" /></p></p><section><br  /></section><p><strong><span>以上数据显示，RNA联合血清总抗体检测可进一步提高新冠感染诊断的敏感性，具有重要的临床和公共卫生价值。</span></strong></p><p><br  /></p><p><span>正如Mary 教授评论所说，抗体与核酸联合检测意义重大，这也逐渐被国家和大众所认可。4月11日，美国宣布除核酸检测外，将大规模开展新冠抗体检测；近日，我国中央应对新冠肺炎疫情工作领导小组会议中也提出大规模开展核酸和抗体检测，对重点人群应检尽检，对人员聚集单位愿检尽检。</span></p><p><br  /></p><p><span>相较其他抗体指标，总抗体（Ab）检测灵敏度更高，与核酸互补灵敏度最佳，可大幅度提高新冠感染的检出率。对于来自高危国家或地区的入境人员、重大会议或集会活动参与者、高流行区复工复学人员等，联合核酸和总抗体检测，可进一步提高对带毒者的筛查敏感性，及时发现潜在传染源、控制传播范围、降低传播风险。</span></p><section><br  /></section><section data-tools="gulangu" data-id="97269"><section><section><p><span><strong>编辑简介</strong></span></p></section><section><section><br  /></section><section><p><img src="image/20201014/cee006e9aa6f22cf69a9e48a6d9981ed_5.png" /></p></section><section><br  /></section></section></section></section><p><br  /></p><p><p><img src="image/20201014/ab1042589a6de4a415cd2daaba641f3a_10.png" /></p></p><section><br  /></section><section><span>玛丽·E·威尔逊（Mary E. Wilson）医学博士，美国加利福尼亚大学旧金山分校医学院流行病学和生物统计学专业教授；哈佛大学T.H.Chan公共卫生学院全球健康与人口兼职教授；著作：《Antibiotics: What Everyone Needs to Know》（牛津大学出版社，2019年）。学术领域包括结核病，感染生态学，新发感染，疾病分布的决定因素，旅行医学和疫苗。曾任职于CDC免疫实践咨询委员会和墨西哥国家公共卫生研究所学术咨询委员会，为CDC国际旅行健康信息医学编辑。</span></section><section><br  /></section><section><br  /></section><section><span>参考文献：</span></section><section><span>(1)Zhao J et al. Antibody responses to SARS-CoV-2 in patients of novel coronavirus disease 2019. Clin Infect Dis 2020 Mar 28; [e-pub]. (https://doi.org/10.1093/cid/ciaa344)</span></section><section><span>(2)Mary E. Wilson, MD. Serologic Tests for SARS-CoV-2: First Steps on a Long Road.NEJM Journal Watch, March 31, 2020 </span></section><p><br  /></p><section data-role="paragraph"><section><span>来源：体外诊断网</span></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_11.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" 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