新冠病毒检测试剂盒研发技术不断突破，检测时间最快2分钟

admin · 发表于 2020-10-14 12:44:36

                  <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><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"><br  /></section><section><section><section powered-by="gulangu"><section><p><span>当病毒侵入人体，机体感受外界刺激时，会产生具有保护作用的蛋白质，即抗体。新型冠状病毒IgM/ IgG检测试剂盒就是用抗原测抗体，检测人体内是否存在并非注射疫苗所得的相应抗体，间接证明感染。</span></p></section></section></section></section><section powered-by="gulangu"><section><br  /></section></section><section><section><section powered-by="gulangu"><p>CT影像需患者肺部发生病变后才可以确认感染类似，如果血液中同时存在与检测用的标准抗原相互作用的抗体，出现抗体的交叉反应，这时候就会出现“假阳性”。新型冠状病毒IgM/ IgG检测试剂盒可提前一步排除假阳性、假阴性，实现快速便捷确诊。</p></section></section></section><section><br  /></section><section><p><img src="image/20201014/4abaaa05bec392a5e80fc8a0eb8a13e3_2.png" /></p></section><section><br  /></section><section><strong><span>武汉本土企业未来组：成功研制新型冠状病毒试剂盒</span></strong></section><section><br  /></section><section><span>在疫情爆发期间，未来组动员核心研发团队，紧急攻关，开展基于第三代单分子新诊断技术的研发，成功研制出新型冠状病毒试剂盒和宏基因组检测技术。</span></section><section><br  /></section><section><span>未来组科研人员表示：“疫情的蔓延，让我们心急如焚，作为国内首家基于第三代测序技术的精准医疗公司，尤其是作为一家武汉本地企业，我们也热切的期待能贡献自己的一点点微薄的力量。”</span></section><section><span><br  /></span></section><section><br  /></section><section><span>武汉未来组生物科技有限公司,是中国首家第三代测序技术应用于基础科学和医学科研的国家高新技术企业。未来组专注于三代测序技术的研发与技术积累，凭借对市场的敏锐嗅觉成为中国三代测序市场的引领者。</span></section><section><br  /></section><section><section data-mid=""><section data-mpa-template="t" data-mid="" data-mpa-category="模板"><section data-mid=""><section data-mid=""><h2><p><img src="image/20201014/2d462d10a20207190c03d56eebe4bdb5_3.png" /></p></h2><h2><span><strong><span>一滴血、15分钟！</span></strong></span></h2><section><br  /></section><section><span>2月14日，在中国工程院院士钟南山的指导下，广州医科大学呼吸疾病国家重点实验室联合中国科学院广州生物医药与健康研究院、广州再生医学与健康广东省实验室等，研发出新型冠状病毒IgM抗体快速检测试剂盒，并已在实验室和临床完成初步评价。</span></section><section><br  /></section><section><span>该试剂盒应用胶体金免疫层析技术，采用间接法检测人新型冠状病毒（SARS-COV2）IgM抗体，仅需采取一滴血就可在15分钟内肉眼观察获得检测结果，且患者的血浆稀释500至1000倍后，仍能检测出阳性条带。该试剂盒与目前诊断所用的RT-PCR核酸检测相比，检测更加简单高效，灵敏度强和特异性高，能够有效突破现有检测技术对人员、场所的限制，缩短检测用时，实现疑似患者的快速诊断和密切接触人群的现场筛查，推动了诊断筛查的前移下移。</span></section><section><br  /></section><section><br  /></section><section><p><img src="image/20201014/60d39eca17dce469b13ce699f92bb400_4.jpg" /></p></section><section><br  /></section><section><span>试剂盒在湖北某医院进行了应用试验。通过对部分临床已确诊为新型冠状病毒感染阳性（但PCR核酸检测阴性的）患者血样进行复检，该试剂盒能检出相当部分（IgM）阳性，提示可与核酸检测形成互补。同时，在取自湖北、广州600多份临床样本的检测试验中，试剂盒的（IgM）阳性检出率与临床诊断结果具有高度的符合率。</span></section><section><br  /></section><section><span>目前该试剂盒（科研用）样品已大批送至湖北省武汉市、黄冈市、大冶市等地基层卫生机构，与核酸检测等技术联合用于检测新型冠状病毒感染的测试评估。</span></section><section><br  /></section><section><br  /></section><h2><p><img src="image/20201014/286acae416348d11b58f820eb1ada867_5.png" /></p></h2><p><br  /></p><section><span>免提取荧光PCR法，最快2分钟</span></section><section><br  /></section></section></section></section></section></section><section data-role="outer" label="Powered by gulangu"><section><p><img src="image/20201014/fa8027e9d675e2d4ccbabd0ecc0c9cea_6.png" /></p></section><section><span>（免提取一步法核酸荧光PCR检测结果）</span></section><section><span><br  /></span></section><section><span><strong><span>浙江研发出新冠病毒快速检测试剂盒，最快2分钟完成检测。</span></strong></span></section><section><span><br  /></span></section><section><span>2月20日，由杭州医学院吕建新教授担任首席科学家，杭州医学院、浙江东方基因生物制品股份有限公司、浙江省疾病预防控制中心三方组成的联合攻关组研制的三类产品（病毒核酸、抗体、抗原检测）中的病毒核酸和病毒抗体两类产品取得突破，已开发完成了新冠肺炎病毒（2019-nCoV）核酸诊断试剂盒，现又开发完成了新型冠状病毒 IgM/IgG抗体检测试剂（胶体金法）。</span></section><section><span><br  /></span></section><section><span>新冠肺炎核酸诊断试剂盒已完成近500例临床样本验证，</span><span><strong>试剂盒无需样本核酸提取，融合样品裂解液于扩增体系</strong></span><span>，咽拭子、痰液等临床标本洗液或标本保存液免核酸提取直接进入PCR体系，实现闭管封闭式扩增最快29 分钟左右完成检测，灵敏度达 300 拷贝/毫升以下，与现有制备核酸后检测的病毒实时荧光 PCR 试剂相比，符合率超过97%，特异性高于99%，且更快速和安全。</span></section><section><span><br  /></span></section><section><span>经大量实验室以及临床样本验证，表明IgM/IgG双指标快速诊断胶体金试剂，最快2分钟完成检测。</span></section><section><span><br  /></span></section><section><span>该检测操作简便，无需仪器，</span><strong><span>只需10μL指尖全血滴入检测孔</span></strong><span>，对感染3-7天的样本即可检出，准确率97%以上，从而极大降低检测时感染风险。</span></section><section><span><br  /></span></section><section><span>检验抗体呈阳性结果则表明：患者当前处于感染状态或既往感染。已开发完成的胶体金快速检测产品，</span><strong><span>可大量用于企业复工、大型活动甄别、学校返校、家庭自测等应用场景</span></strong><span>。</span></section><section><span><br  /></span></section><section><span>联合攻关组开发的病毒抗体二联检，可进一步排除假阳性、假阴性，实现快速便捷确诊。正在开发中的病毒抗原检测试剂也取得重要进展，后续三联检有望将进一步缩短检出时间，提高特异性和灵敏性。</span></section><section><span><br  /></span></section><section><p><img src="image/20201014/239c5ca778e5dba92bed096621eb3ea9_7.png" /></p></section><section><span>（IgM/IgG抗体胶体金检测试纸，2分钟左右检出）</span></section><section><br  /></section><section><span>目前，新型冠状病毒核酸检测试剂盒（免提取荧光PCR法)、新型冠状病毒胶体金检测试剂，已经在欧盟注册备案。</span></section><section><span><br  /></span></section><section><span>近日，已陆续接到来自于英国、法国、瑞士、奥地利、格鲁吉亚、印度、日本、美国等国家和地区的订单。在国内，攻关团队正加大法定检测机构临床试验和注册检验力度，积极组织各种生产物料，生产线，大批量生产新型冠状病毒IgM/IgG的抗体检测试剂（胶体金法）和核酸诊断试剂盒，用于抗击新冠肺炎疫情。</span></section></section><section powered-by="gulangu"><br  /></section><section powered-by="gulangu"><span>来源：广州日报、浙江新闻、21世纪经济综合</span></section><section powered-by="gulangu"><br  /></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></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  /></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 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