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刚刚出炉!21家新冠病毒核酸检测试剂大盘点!(附详细介绍)

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发表于 2020-10-14 12:05:02 | 显示全部楼层 |阅读模式

                    

                    

                    
                    
                    <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.jpg" /></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-tools="gulangu" data-id="97917"><section><section><section data-bgless="spin" data-bgopacity="30%"><br  /></section><section data-width="100%" data-opacity="1" data-rotate="0"><section><section><section><p><span>新冠病毒全基因序列自2020年1月11日被公布后,各类病毒检测方法和设备随之快速发展起来。</span></p></section></section></section></section><section><br  /></section><section><span>截至今日(6月11日),国家药品监督管理局共批准新冠病毒检测试剂42个,其中核酸检测试剂22个、21家,抗体检测试剂20个。</span></section><section><br  /></section><p><p><img src="image/20201014/8a3b863d5207cce62107939b22959e76_2.png" /></p></p><section><br  /></section><section><span><strong><span>新冠核酸检测vs抗体检测,怎么选?</span></strong></span></section><section><br  /></section><section><span>目前,指南推荐能用来确诊新冠病毒感染的仍然只有核酸检测。对于新冠病毒核酸检测阴性的疑似病例,可以采用抗体检测作为补充检测指标。对于新冠病毒核酸检测的疑似病例,也可以用抗体检测来协同使用。</span></section><section><br  /></section><section><span>与抗体检测相比,核酸检测更加灵敏,也是实验室检测的“金标准”。</span></section><section><br  /></section><section><p><img src="image/20201014/6be814537c80a94ff319e3abf470b4fe_3.png" /></p></section><section><br  /></section><section><span>所以采用核酸检测来作为确诊指标,抗体检测作为疑似病例的补充指标。</span></section><section><span><br  /></span></section><section><span>各生物公司的新冠肺炎的检测试剂开发中,方法五花八门。今天,我们就来盘点一下核酸检测的方法学。</span></section><section><span>&nbsp;</span></section><section><strong><span>检测试剂盒(核酸类):</span></strong></section><section><br  /></section><p><span><strong><p><img src="image/20201014/fffa465f20c59094280fd1d705415713_4.png" /></p></strong></span></p><section><br  /></section><section data-tools="gulangu" data-id="85616"><section data-width="100%"><section><strong><span data-brushtype="text">荧光PCR法</span></strong></section><p><p><img src="image/20201014/481ffde563f6ad2360566915c8ef169a_5.png" /></p></p></section></section><section><span>是新冠病毒核酸检测最常用的方法。</span></section><section><br  /></section><section><span>目前有15家企业的核酸检测试剂盒均采用该方法。</span></section><section><br  /></section><p><p><img src="image/20201014/0845dd77529bb153d184a9fb8faae985_6.png" /></p></p><section><br  /></section><section><span>PCR法指的是聚合酶链式反应,能将微量的DNA大幅增加。用于检测新冠病毒时,由于新冠病毒是RNA病毒,需要先将病毒RNA逆转录为DNA,再进行PCR检测。</span></section><section><br  /></section><section><span>常规的实时荧光定量PCR方法,操作技能要求严格,需经专业培训,执PCR上岗证上岗,必须在PCR认证实验室开展。</span></section><section><span>&nbsp;</span></section><section><span>下列因素可能导致检测结果出现误差:</span></section><section><br  /></section><section><span>保存不当或未及时送检:RNA病毒很容易降解,因此,获得患者样本后,需要规范地保存,并尽快进行检测。</span></section><section><br  /></section><section><span>结果解读错误:目前批准的检测产品都是根据新型冠状病毒基因组中开放读码框1a/b、包膜蛋白和核衣壳蛋白进行选择。但不同产品的检测引物、探针设计存在不同,有单靶区段、双靶区段、三靶区段的检测和判读差别。因此,如果没有严格按照不同的说明书进行判读,有可能导致结果判断错误。</span></section><section><br  /></section><section data-tools="gulangu" data-id="97836"><section><section><section><section><strong data-brushtype="text">上海之江</strong></section></section></section></section></section><section><br  /></section><section><span>国械注准20203400057</span></section><section><span>技术原理:RT-PCR</span></section><section><span>靶点基因:ORF1ab 基因,E 基因和 N 基因</span></section><section><span>样本类型:痰液、肺泡灌洗液、咽拭子最低检测限:1000copies/ml</span><br  /></section><p><p><img src="image/20201014/6eb1aed723cce16822ef32453684dbd5_7.png" /></p></p><section><span><strong><span>&nbsp;<br  /></span></strong></span></section><section><span><strong><span>仪器:Mic-4 qPCR仪</span></strong></span></section><section><br  /></section><section data-tools="gulangu" data-id="93278"><section data-width="100%"><section><section data-width="50%"><p><img src="image/20201014/8188ed086336a06c151724eab409f234_8.png" /></p><section data-width="100%"><section data-brushtype="text"><br  /></section></section></section><section data-width="50%"><p><img src="image/20201014/889b10dca267bd80b23c86208526e2f7_9.png" /></p><section data-width="100%"><section data-brushtype="text"><br  /></section></section></section></section><p><p><img src="image/20201014/baf6bdbc18ea3b04a347235e2ff22c36_10.png" /></p></p><section><br  /></section></section></section><section><span><strong><span>产品特点:</span></strong></span></section><section><br  /></section><section><span>●变温速度快:Magnetic induction cycler (Mic) qPCR仪采用磁感应技术加热样品,通过风扇强制空气流动冷却降温,实现循环扩增过程中的极速变温,35个循环反应耗时少于25分钟(40循环少于30分钟)。</span></section><section><span><br  /></span></section><section><span>●荧光通道多:无论是双色还是四色荧光配置,伴随转子快速旋转,仅需1秒钟,Mic qPCR即可完成所有孔位多重荧光信号的采集。</span></section><section><span><br  /></span></section><section><span>●信号读取快:每个通道都具有独立的高能LED光源、独立的滤光片和检测器,无需浪费时间切换滤光片。</span></section><section><span><br  /></span></section><section><span>●光学免校准:整个光学系统元件都固定安装,不会偏移,仪器移动后无需校正,也无需参考染料校准。</span></section><section><span><br  /></span></section><section><span>●梯度分辨率:Mic qPCR具有卓越的样品重复性、实验重复性、仪器间重复性。可以用于仅2倍差异的基因表达水平的检测。</span></section><section><span><br  /></span></section><section><span>●变温同步性:Mic qPCR通过独特的铝制转子加热,无论是变温过程还是保持恒温,均有温度均一性。而模块加热的qPCR仪,只能在恒温时才能保障各孔温度的均一性,各孔间加热和冷却速率不同,可能导致孔间差异。</span></section><section><br  /></section><section data-tools="gulangu" data-id="97836"><section><section><section><section><strong data-brushtype="text">捷诺生物</strong></section></section></section></section></section><section><br  /></section><section><span>国械注准20203400058</span></section><section><span>技术原理:RT-PCR</span></section><section><span>靶点基因:ORF1ab 基因, N 基因</span></section><section><span>样本类型:鼻咽拭子、痰液</span></section><section><br  /></section><p><p><img src="image/20201014/d5e32ffc5dc3b9c891b447f499cf2918_11.png" /></p></p><section><br  /></section><section data-tools="gulangu" data-id="97836"><section><section><section><section><strong data-brushtype="text">华大基因</strong></section></section></section></section></section><section><br  /></section><section><span>国械注准20203400060</span></section><section><span>技术原理:RT-PCR</span></section><section><span>靶点基因:ORF1ab 基因</span></section><section><span>样本类型:肺泡灌洗液、咽拭子</span></section><section><br  /></section><p><p><img src="image/20201014/d930d75aa3ca1167422083c80b239ad1_12.png" /></p></p><section><span>&nbsp;</span><br  /></section><section data-tools="gulangu" data-id="97836"><section><section><section><section><strong data-brushtype="text">达安基因</strong></section></section></section></section></section><section><br  /></section><section><span>基因靶点:ORF1ab和N基因</span></section><section><span>样本类型:咽拭子和痰液</span></section><section><span>产品内标:内源性内标</span></section><section><br  /></section><p><p><img src="image/20201014/cbe4318ba4b69fd2808aa74ab2f47cd8_13.png" /></p></p><section><br  /></section><section><span><strong><span>仪器:ABI7500 实时荧光量PCR仪、AGS4800 实时荧光量PCR仪</span></strong></span></section><section><br  /></section><p><p><img src="image/20201014/0c81ae7e62c7a7950c3853d213730d26_14.png" /></p></p><section><span><strong><span>ABI7500 实时荧光量PCR仪</span></strong></span><br  /></section><section><br  /></section><section><span><strong><span>产品特点:</span></strong></span></section><section><br  /></section><section><span>●96孔通量,加热冷却方式为Peltier半导体控温;</span></section><section><span>●激发光源为卤钨灯,使用寿命≥2000小时,配备时间监测及自我诊断程序;</span></section><section><span>●检测器为CCD,实时动态检测整体成像,96个样本成像时间差小于0.01s;</span></section><section><span>●五个荧光通道,带五组激发光与发射光滤光片,可同时检测五种荧光。无需额外购买滤光片,即可准确使用FAM?/SYBR? Green、VIC?/JOE?、NED?/TAMRA?/CY3?、ROX?/Texas Red?与CY5?染料5、试剂耗材开放,可适用单管、8联管和96孔板等耗材。</span></section><section><br  /></section><p><p><img src="image/20201014/cb2bf7e86a561f3e244a39d9c834cff1_15.png" /></p></p><section><span>AGS4800 实时荧光量PCR仪</span></section><section><br  /></section><section><span>●6通道组合检测,最多可拓展至8通道;</span></section><section><span>●高通量样本,最多可达144个样本同时检查;多变灵活的配套方案(样本量:48、96、144可选);</span></section><section><span>●三个独立进样系统,样本可同时/独立加载运行分析;</span></section><section><span>●检测器:高灵敏度光电传感器;</span></section><section><span>●自带阳性检出率分析,预警实验室污染。</span></section><section>&nbsp;</section><section data-tools="gulangu" data-id="97836"><section><section><section><section><strong data-brushtype="text">圣湘生物</strong></section></section></section></section></section><section><br  /></section><section><span>圣湘生物研制出的新型冠状病毒(2019-nCoV)核酸检测试剂盒(PCR-荧光探针法),采用圣湘生物RNA一步法技术平台,结合公司移动分子诊断平台(POCT),最快可在30分钟内出检测结果。</span></section><section><span><br  /></span></section><p><p><img src="image/20201014/de6b15a86ed685492ea04261331207cb_16.png" /></p></p><section><span>&nbsp;</span><br  /></section><section><span><strong><span>仪器:</span></strong></span></section><section><br  /></section><section><span>圣湘生物核酸检测分析仪(iPonatic)可简便、快速地实现DNA和RNA病原体核酸检测。该仪器可适配圣湘生物新型冠状病毒2019-nCoV核酸检测试剂盒(荧光PCR法)使用,适用于体外定性检测样本中的新型冠状病毒2019-nCoV特异性的ORF1ab基因和N基因序列。</span></section><section><span><br  /></span></section><p><p><img src="image/20201014/d91c9673a2885c4debc2bdee903b82d9_17.png" /></p></p><p><br  /></p><section><span><strong><span>产品特点:</span></strong></span></section><section><br  /></section><section><span>基因靶点:ORF1ab和N基因</span></section><section><span>样本类型:咽拭子和肺泡灌洗液</span></section><section><span>技术优势:圣湘生物独创的“RNA一步法”技术</span></section><section><span>检测下限:200copies/mL</span></section><section><span>产品内标:全程内源性管家基因监控</span></section><section><span>通量选择:</span></section><section><span>(1)批量PCR模式:1个操作人员在2小时内(前处理仅需10分钟)可以完成96份样本的检测</span></section><section><span>(2)分子POCT模式:可在30分钟出检测结果</span></section><section><span>&nbsp;</span></section><section data-tools="gulangu" data-id="97836"><section><section><section><section><strong data-brushtype="text">明德生物</strong></section></section></section></section></section><section><br  /></section><section><span>明德生物研制出的新型冠状病毒(2019-nCoV)核酸检测试剂盒(快速荧光PCR法),采用一步式多重快速荧光PCR技术,对新型冠状病毒ORF1ab与编码核衣壳蛋白N基因中特异性保守序列进行快速检测,用于对2019新型冠状病毒感染疑似病例、疑似聚集性病例及其他需要提供快速辅助诊断方案。</span></section><section><br  /></section><section><span>该设备高度集成化,仪器小巧、快速且便携,30分钟出结果,可在社区服务中心、二级医院以及三级医院发热门诊现场使用。</span></section><section><span>&nbsp;&nbsp;</span></section><p><p><img src="image/20201014/9f6f8d5a95a345dda56059e46769b17d_18.png" /></p></p><section>&nbsp;<br  /></section><section data-tools="gulangu" data-id="97836"><section><section><section><section><strong data-brushtype="text">北京金豪</strong></section></section></section></section></section><section><br  /></section><section><span>金豪制药核酸检测试剂盒根据荧光PCR技术原理,针对2019-nCoV目的基因ORF1ab与N基因设计特异性引物和Taqman探针,通过荧光PCR检测仪进行检测,从而实现对2019-nCoV的定性检测。试剂盒以正常人上皮细胞中广泛存在的核糖核酸酶P的mRNA为正常人体细胞对照,对提取和检测过程进行监控,达到检测的目的。</span></section><section><span><br  /></span></section><p><p><img src="image/20201014/993229d6f6c0ebbf5ae26192bff6258b_19.png" /></p></p><p><p><img src="image/20201014/43eeaa8c31294bb6fc08678d2af28a9a_20.png" /></p><br  /></p><section><span>&nbsp;</span><br  /></section><section><span><strong><span>仪器:</span></strong></span></section><section><br  /></section><p><p><img src="image/20201014/d5cb3b4866a1c97e7adfb59fa3ee8619_21.png" /></p></p><section><span><strong><span>实时荧光定量PCR仪</span></strong></span></section><p><p><img src="image/20201014/1fba568508adacc771a66e1aa4ca2b88_22.png" /></p></p><section><br  /></section><section data-tools="gulangu" data-id="97836"><section><section><section><section><strong data-brushtype="text">硕世生物</strong></section></section></section></section></section><section><br  /></section><section><span>硕世生物开发的检测试剂盒可实现对ORF1ab、E、N三个基因靶标的双重和三重检测。同时冠状病毒通用型核酸检测试剂盒(货号:JC10155),还可实现对多种冠状病毒的同时检测,包含:OC43、NL63、HKU1、229E、SARS、MERS、新型冠状病毒(nCov-2019,ORF1ab基因靶标)七种感染人的冠状病毒及其他一些哺乳动物及禽类感染的冠状病毒,满足多种检测需求。<br  /></span></section><section><br  /></section><p><p><img src="image/20201014/db81302254b0c2a9b23881eb4849e9dc_23.png" /></p></p><p><p><img src="image/20201014/18ece92821e7ef1363a6c7dce41579e5_24.png" /></p></p><p><p><img src="image/20201014/429d8783a34e995890ecc981fc401fc9_25.png" /></p></p><p><br  /></p><section data-tools="gulangu" data-id="97836"><section><section><section><section><strong data-brushtype="text">东方基因</strong></section></section></section></section></section><section><span>&nbsp;</span></section><section><span>5月21日,浙江东方基因生物制品股份有限公司新冠核酸检测试剂盒获得国家药监局医疗器械注册证。</span></section><section><br  /></section><section><span>试剂盒无需样本核酸提取,融合样品裂解液于扩增体系,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><br  /></section><p><p><img src="image/20201014/8f1272e35ec0c0bb00ca55269c043f5f_26.png" /></p></p><section><span>&nbsp;</span><br  /></section><section data-tools="gulangu" data-id="97836"><section><section><section><section><strong data-brushtype="text">上海复星</strong></section></section></section></section></section><section><br  /></section><section><span>3月25日,上海复星长征医学科学有限公司新型冠状病毒(2019-nCoV)核酸检测试剂盒(荧光PCR法)获得国家药品监督管理局应急审批上市,医疗器械注册证编号:国械注准20203400299。</span></section><section><br  /></section><p><p><img src="image/20201014/b1ec7c593bec3bd6e9f2ba6ebd71b25a_27.png" /></p></p><section><span>&nbsp;</span></section><section data-tools="gulangu" data-id="97836"><section><section><section><section><strong data-brushtype="text">迈克生物</strong></section></section></section></section></section><section><br  /></section><section><span>3月2日,迈克生物公司新型冠状病毒2019-nCoV核酸检测试剂盒(荧光PCR法)获得产品注册证书。是目前国内唯一一家同时拥有新冠核酸和抗体试剂盒双证的企业。</span><br  /></section><section><br  /></section><section><span>迈克生物新型冠状病毒2019-nCoV核酸检测试剂盒(荧光PCR法)为三重靶标设计,能更大程度避免新冠病毒的漏检;同时在检测试剂中添加内标,防止假阴性检测结果出现;临床试验显示试剂盒拥有良好的试剂性能,灵敏度和特异性高,检验耗时相对较短,可实现2个小时内完成96个测试。</span></section><section><br  /></section><p><p><img src="image/20201014/e256d3927425a3a3d4a5f4f90e42a1bf_28.png" /></p></p><section>&nbsp;<br  /></section><section data-tools="gulangu" data-id="97836"><section><section><section><section><strong data-brushtype="text">卓诚惠生</strong></section></section></section></section></section><section><br  /></section><section><span>2月27日,北京卓诚惠生生物科技股份有限公司(简称卓诚惠生)研发的新型冠状病毒(2019-nCoV)核酸检测试剂盒获批上市,同时实现新冠病毒ORF1ab基因、N基因和E基因的核酸检测。该产品采用荧光PCR技术,检测灵敏度为200copies/ml,检测时间90分钟。获批上市后,该产品主要用于疑似病例的诊断和高风险人群的筛查。</span></section><section><br  /></section><section><br  /></section><p><p><img src="image/20201014/9887d0c8d53268d49b0dba666e374dbe_29.png" /></p></p><section><br  /></section><section data-tools="gulangu" data-id="97836"><section><section><section><section><strong data-brushtype="text">上海伯杰</strong></section></section></section></section></section><section><br  /></section><section><span>2月1日,通过国家药监局应急审批,取得了医疗器械注册证。</span></section><section><span><br  /></span></section><section><br  /></section><section><span><strong><span>特点:</span></strong></span></section><section><br  /></section><section><span>●双靶标:ORF1ab、N基因检测</span></section><section><span>● 样本类型:咽拭子、鼻拭子、痰液。</span></section><section><span>● 内源性内标:防止假阴性</span></section><section><span>●充分验证</span></section><section><br  /></section><section><span>通过中国食品药品检定研究院验证(国家参考品)</span></section><section><br  /></section><section><span>通过国家食品药品监督管理局北京医疗器械质量监督检验中心验证(企业自制参考品)</span></section><section><br  /></section><p><p><img src="image/20201014/28602c9722d9d69b8179b810ee777143_30.png" /></p></p><p><p><img src="image/20201014/884c605505a81f496bc1c90a6a6bb394_31.png" /></p><br  /></p><section><br  /></section><section data-tools="gulangu" data-id="97836"><section><section><section><section><strong data-brushtype="text">联合医学</strong></section></section></section></section></section><section><br  /></section><section><span>6月5日,深圳联合医学科技有限公司(新型冠状病毒(2019-nCoV)核酸检测试剂盒(荧光PCR法)) 获得国家药监局医疗器械注册证。</span></section><section><span><br  /></span></section><section><span>01.16:研发产品完成验证</span></section><section><span>03.18:获得欧盟CE认证</span></section><section><span>05.04:列入商务部出口白名单</span></section><section><span>06.05:获得国家药监局医疗器械注册证&nbsp;</span></section><section><br  /></section><section><span><strong><span>特点:</span></strong></span></section><section><br  /></section><section><span>本试剂盒用于体外定性检测新型冠状病毒肺炎疑似病例、聚集性病例、其他需要进行新型冠状病毒感染诊断或鉴别诊断者的咽拭子、痰液样本中新型冠状病毒(2019-nCoV)ORF1ab基因。</span></section><section><br  /></section><section><br  /></section><p><p><img src="image/20201014/f925a275f2f73ab7277a6d7a0a9d6688_32.png" /></p></p><section><br  /></section><section data-tools="gulangu" data-id="97836"><section><section><section><section><strong data-brushtype="text">纳捷诊断</strong></section></section></section></section></section><section><br  /></section><section><span>2020年6月8日,上海润达榕嘉生物科技有限公司(以下简称“上海润达榕嘉”)携手北京纳捷诊断试剂有限公司(以下简称“纳捷诊断”)联合研发的“新型冠状病毒2019-nCoV核酸检测试剂盒(荧光PCR法)” 获得中国国家药品监督管理局(NMPA)批准</span></section><section><span>&nbsp;</span></section><section><span><strong><span>特点:</span></strong></span></section><section><br  /></section><section><span>● 样本采集即灭活——保证安全性</span></section><section><span>样本采集管集样本灭活、核酸裂解、RNA保存与一体,且运输安全、方便检测。</span></section><section><span>● 免核酸提取、免试剂配制——操作简捷、无污染、耗时短</span></section><section><span>采用免核酸提取、免试剂配制的原创技术,样本直接进行RT-PCR扩增,无需核酸纯化设备。</span></section><section><span>● 多色荧光,内标质控——可监控假阴性</span></section><section><span>采用三色荧光分型、质控,同时检测nCOV的ORF1ab基因、N基因和内标质控。</span></section><section><br  /></section><p><p><img src="image/20201014/54a76b7d91de93c1ece18a535c9b4f82_33.png" /></p></p><section><br  /></section><section data-tools="gulangu" data-id="85616"><section data-width="100%"><section><strong><span data-brushtype="text">联合探针锚定聚合测序法</span></strong></section><p><p><img src="image/20201014/481ffde563f6ad2360566915c8ef169a_5.png" /></p></p></section></section><section><span><br  /></span></section><section><span>目前只有华大生物一家的核酸试剂盒采用该方法。</span></section><section><span><br  /></span></section><section><br  /></section><section><span>这种检测主要是用专门的仪器检测测序载片上DNA纳米球携带的基因序列。</span></section><section><span><br  /></span></section><section><br  /></section><section><span>这种检测的灵敏度高,不容易漏诊,但结果也容易受多种因素的影响而不准,包括:未及时检测样本:和荧光PCR法一样,如果没有规范保存和尽快检测,结果可能不准。</span></section><section><span><br  /></span></section><section><br  /></section><section><span>检测场所的室温过高:这也会影响检测结果的准确性。不同的检测仪器、试剂盒也可能对结果造成影响。</span></section><section><span><br  /></span></section><section><br  /></section><section data-tools="gulangu" data-id="85616"><section data-width="100%"><section><strong><span data-brushtype="text">恒温扩增芯片法</span></strong></section><p><p><img src="image/20201014/481ffde563f6ad2360566915c8ef169a_35.png" /></p></p><p><br  /></p></section></section><section><span>基因芯片检测是传统的病毒学诊断方法之一,检测原理是基于核酸之间的互补结合特性开发的一种检测方式,能够用于定性或定量测量存在于生物体内的核酸。</span></section><section><br  /></section><section><span>此次获批的这个恒温芯片,能对新冠病毒在内的6种呼吸道病毒进行检测。1.5小时内便可获得结果。</span></section><section><br  /></section><section><span>和PCR相比,基因芯片准确率高,时间更短,但价格也更为昂贵、且检测通量(单位时间内所能产生的数据量)相对更低。</span></section><section><br  /></section><section data-tools="gulangu" data-id="97836"><section><section><section><section><strong data-brushtype="text">博奥晶芯</strong></section></section></section></section></section><h5><br  /></h5><section><span>能在1.5小时内检测包括新型冠状病毒(2019-nCoV)在内的“六项呼吸道病毒核酸检测芯片试剂盒”,并获得国药监局应急审批批准(注册证编号:国械注准20203400178)。</span></section><section><span><br  /></span></section><section><br  /></section><section><span>此次获CE-IVD认证的恒温扩增呼吸道常见多病毒核酸快速检测芯片只需采集患者的鼻、咽拭子等分泌物样本,在1.5小时内便可一次性检测包括新型冠状病毒(2019-nCoV)在内的6种呼吸道常见病毒。</span></section><section>&nbsp;</section><p><p><img src="image/20201014/43eeaa8c31294bb6fc08678d2af28a9a_20.png" /></p></p><p><p><img src="image/20201014/2f11bebcc09a6bc7908ec1ef7d3d4f6d_37.png" /></p><br  /></p><p><br  /></p><section><br  /></section><section data-tools="gulangu" data-id="85616"><section data-width="100%"><section><strong><span data-brushtype="text">恒温扩增芯片法恒温扩增-实时荧光法</span></strong></section><p><p><img src="image/20201014/481ffde563f6ad2360566915c8ef169a_35.png" /></p></p></section></section><section data-tools="gulangu" data-id="97836"><section><section><section><section><strong data-brushtype="text">优思达</strong></section></section></section></section></section><section><br  /></section><section><span>国械注准20203400241,系国内获批上市的首款新冠分子POCT试剂。</span></section><section><span><br  /></span></section><section><br  /></section><section><span>据优思达官方介绍,此试剂配套该公司生产的一款全自动核酸分析仪使用,无需复杂的人员培训,无需昂贵的分子实验室,独立双通道,可现场进行快速检测。核酸提取、扩增、检测全自动一体化。是目前国家批准的第一个新冠核酸POCT试剂。</span></section><section><br  /></section><section><br  /></section><p><p><img src="image/20201014/ac82c8da2ab34ae077a5ce0e996812ab_39.png" /></p></p><section><span>&nbsp;</span></section><section data-tools="gulangu" data-id="85616"><section data-width="100%"><section><strong><span data-brushtype="text">RNA捕获探针法</span></strong></section><p><p><img src="image/20201014/481ffde563f6ad2360566915c8ef169a_35.png" /></p></p></section></section><section data-tools="gulangu" data-id="97836"><section><section><section><section><strong data-brushtype="text">上海仁度</strong></section></section></section></section></section><section><br  /></section><section><span>这款新冠病毒2019-nCoV核酸检测试剂, 采用RNA特异靶标捕获和转录介导的恒温扩增实时检测技术,在一个反应管中自动化完成核酸提取、扩增步骤,90分钟可出结果,并可实现连续并行检测,提升检测效率。相关数据显示,检测结果灵敏度、特异性能够达到传统PCR方法的水平。</span></section><section><span><br  /></span></section><p><p><img src="image/20201014/eea9977697ff509aa6960ec1f11435f4_41.png" /></p></p><section><span>&nbsp;<br  /></span></section><section><span>不同于市面上其他产品,仁度生物的全自动新型冠状病毒核酸检测平台(AutoSAT)采用了智能化的检测方法。这是一种整合了核酸提取、扩增反应和结果报告的一体化产品。正是由于AutoSAT采用了仁度生物独特的RNA实时荧光恒温扩增检测技术(SAT),使得核酸提取、纯化、扩增检测、报告结果实现了全程一体化。整个反应在密封的环境中,保证了实验的生物安全性。</span></section><section><br  /></section><section><span>该系统具有高通量(8小时200个,24小时700个),检测过程类似于生化免疫检测,样本可以随到随检(单个或批量样本都可以随时上机),快速(90分钟出第一个结果,并连续报告,平均2分钟一个结果),自动报告结果(软件自动判读)的特性,特别适合境外输入性病例以及医疗机构大批量样本的现场、快速排查。</span></section><section><span>&nbsp;</span></section><section data-tools="gulangu" data-id="85616"><section data-width="100%"><section><strong><span data-brushtype="text">RNA恒温扩增-金探针层析法</span></strong></section><p><p><img src="image/20201014/481ffde563f6ad2360566915c8ef169a_35.png" /></p></p></section></section><section data-tools="gulangu" data-id="97836"><section><section><section><section><strong data-brushtype="text">武汉中帜</strong></section></section></section></section></section><section><br  /></section><section><span>基于RNA恒温扩增-金探针层析法的新冠病毒(2019-nCoV)核酸检测试剂盒可在1小时完成病毒RNA检测,实现随到随检,适用于各层级医院及门急诊快速精准筛查,无需核酸提取即可实现病原体RNA的 POCT快速检测。</span></section><p><p><img src="image/20201014/36a96e73d33194a5e5ae739da25e634c_43.png" /></p></p><section>&nbsp;<br  /></section><section><span><strong><span>产品特色:</span></strong></span></section><section><br  /></section><section><span>准确:ORF1ab、E基因双基因检测,提高检测准确性</span></section><section><span>快速:70分钟完成检测,较常规荧光RT-PCR快1倍,早期快速确诊,及时发报告</span></section><section><span>高效:无需核酸提取,一步法标本直接裂解,提高标本批处理效率,减少污染风险</span></section><section><span>简捷:无需特殊仪器,常规恒温设备即可,操作简单,可随到随检</span></section><section><span>不易污染:创新RNA检测技术,扩增产物为RNA,不易造成环境污染</span></section><section><span>全程质控:人内源基因作为质控,实现从标本采集到结果测定全程质控</span></section><section><span>&nbsp;</span></section><section data-tools="gulangu" data-id="85616"><section data-width="100%"><section><strong><span data-brushtype="text">双扩增法</span></strong></section><p><p><img src="image/20201014/481ffde563f6ad2360566915c8ef169a_35.png" /></p></p></section></section><section data-tools="gulangu" data-id="97836"><section><section><section><section><strong data-brushtype="text">武汉中帜</strong></section></section></section></section></section><section><br  /></section><section><span>基于“双扩增技术(DAT)”平台的新冠病毒(2019-nCoV)核酸检测试剂盒,单批次实验在2.5小时内即可完成192个人份测试,满足各级医疗机构对样本通量上的需求。</span></section><section><span><br  /></span></section><p><p><img src="image/20201014/87b36b156bd0d451eb7e836fe5e391a2_45.png" /></p></p><p><br  /></p><section><span><strong><span>产品特色:</span></strong></span></section><section><br  /></section><section><span>准确:ORF1ab、E基因双基因检测,提高检测准确性</span></section><section><span>高通量:自动化仪器3小时单批192个测试</span></section><section><span>高效:无需核酸提取,一步法标本直接裂解,提高标本批处理效率,减少污染风险</span></section><section><span>灵活:配套自动化仪器可多项目同时运行,标本随时加载</span></section><section><span>不易污染:创新RNA检测技术,扩增产物为RNA,不易造成环境污染</span></section><section><span>全程质控:人内源基因作为质控,实现从标本采集到结果测定全程质控</span></section><section><span>&nbsp;</span></section><section><span>资料来源:各企业官网、CACLP体外诊断资讯、IVD资讯、IVD从业者</span></section><section><span>作者:天下、木杉</span></section><section><br  /></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 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