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全球高通量基因测序仪标准发布!中检院联合华大智造等单位发起助力行业标准化

2020-09-14 生物探索 生物探索

近日,国家药品监督管理局正式发布国内首个医疗器械行业基因测序仪标准——《高通量测序仪标准》。

近日,国家药品监督管理局正式发布国内首个医疗器械行业基因测序仪标准——《高通量测序仪标准》,这也是全球首次针对基因测序仪设定标准,体现了我国在基因测序领域的前瞻性和先进性。该标准由中国食品药品检定研究院(第一起草单位)牵头发起,同时联合深圳华大智造科技股份有限公司(第二起草单位)、广州市达瑞生物技术股份有限公司、北京市医疗器械检验所、东莞博奥木华基因科技有限公司、天津诺禾致源生物信息科技有限公司、杭州贝瑞和康基因诊断技术有限公司、安诺优达基因科技(北京)有限公司、illumina Inc.【代理人:宜曼达贸易(上海)有限公司】等单位共同参与撰写。

据了解,新发布的《高通量测序仪标准》内容包括高通量测序仪的范围、规范性引用文件、分类、要求、试验方法、标签和使用说明书、包装、运输、贮存、参考文献。其正式发布标志着基因测序仪及基因测序技术在临床应用将逐步迈入成熟阶段,为行业规范发展和测序技术的广泛应用奠定了有力基础,同时利于更多基因测序技术和产品进入临床应用,造福大众。

全球疫情持续蔓延,高通量基因测序仪需求快速增长

随着全球疫情的持续蔓延,各国对防疫物资的需求快速增长,高通量测序仪也是其中之一。以华大智造为例,其拥有完全自主知识产权及先进水平的多款高通量基因测序仪在此次全球疫情防控中发挥了重要的工具保障作用,包括全球日生产通量最高的DNBSEQ-T7,以及MGISEQ-2000、MGISEQ-200等机型。

全球日生产通量最高的DNBSEQ-T7高通量基因测序仪

基于宏基因组学的高通量测序方法可以对样本中的全部核酸进行检测分析,除了能检测新冠病毒是否存在之外,还可以监测可能的变异,为“早发现、早隔离、早诊断、早治疗”的疫情防控措施提供精准的判断依据。

韩国基础科学研究所RNA研究中心联合国立首尔大学和韩国疾病预防控制中心利用华大智造DNBSEQ技术联合Nanopore单分子测序技术,对新冠病毒感染的Vero细胞总RNA进行了分析,并结合以往研究给出了新冠病毒转录组和表观转录组的高清图谱。

此次疫情防控也让更多用户意识到高通量基因测序仪的重要性,殊不知它们已不断丰富并渗透至医学、健康、环境、农业等各个领域。尽管国内外对高通量基因测序仪的研究日益广泛,临床需求也日趋强烈,但是目前对测序平台的研究、开发和使用尚未有成熟的标准可供参考,导致临床使用中的风险不易把控。因此,亟需出台一套相对完善的国家标准甚至行业标准。

为此,中国食品检定研究院作为发起方,联合深圳华大智造科技股份有限公司(第二起草单位)等国内主要研发单位,对高通量基因测序仪标准进行了研制,并通过各条款可操作性和合理性等充分验证标准进行了科学验证,最后正式发布《高通量测序仪标准》。

基因测序行业迈向标准化,全面助力构建测序应用生态文明

近年来,基因测序技术和平台不断升级迭代,高通量基因测序仪也向着便携、快速、智能等方向发展。《高通量测序仪标准》的发布将全面推进以高通量测序技术为核心的基因检测产品标准化与规范化。在此基础上,测序成本将大幅下降,系统的易用性不断提升,测序应用的深度和广度也将逐步打开,从而深化测序服务在基因科技中的应用,全面构建测序应用的生态文明。

华大智造作为国产测序仪的领导者,一直以来都积极参与并推动行业标准的研制与宣贯,除了此次作为第二起草单位参与《高通量测序仪标准》的制定之外,也曾参与2017年12月29日发布的《高通量基因测序结果评价要求标准》研制。

如今,华大智造已形成完整的高中低通量产品布局,并自主研发了一系列完善的基因测序产品,包括建库试剂、测序试剂、分析软件等。目前,华大智造高通量基因测序仪已广泛用于全00--0球30多个国家和地区。未来,华大智造将继续深耕基因测序领域,不断寻求测序技术的突破和创新,以满足科研和临床对基因测序的多元化需求,为基因测序及生命科技产业贡献先进制造力量。

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  4. [GetPortalCommentsPageByObjectIdResponse(id=1969447, encodeId=705a196944e92, content=<a href='/topic/show?id=6532102e6059' target=_blank style='color:#2F92EE;'>#高通量#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=99, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=102760, encryptionId=6532102e6059, topicName=高通量)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ad7f282, createdName=yang0210, createdTime=Sat May 15 07:48:16 CST 2021, time=2021-05-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1822374, encodeId=64f818223e43b, content=<a href='/topic/show?id=fb18102e6110' target=_blank style='color:#2F92EE;'>#高通量基因测序仪#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=102761, encryptionId=fb18102e6110, topicName=高通量基因测序仪)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=08e4137, createdName=meichuangyi, createdTime=Fri Dec 18 00:48:16 CST 2020, time=2020-12-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1758867, encodeId=e9a51e5886705, content=<a href='/topic/show?id=9fb76191944' target=_blank style='color:#2F92EE;'>#标准化#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=88, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=61919, encryptionId=9fb76191944, topicName=标准化)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a86337383877, createdName=108807375_62823139, createdTime=Tue Aug 24 04:48:16 CST 2021, time=2021-08-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=885638, encodeId=4bcc88563812, content=学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=80, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=64245268311, createdName=14818eb4m67暂无昵称, createdTime=Wed Sep 16 08:12:33 CST 2020, time=2020-09-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1603881, encodeId=11c5160388152, content=<a href='/topic/show?id=06353589e5e' target=_blank style='color:#2F92EE;'>#华大智造#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=82, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=35897, encryptionId=06353589e5e, topicName=华大智造)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c82d19112893, createdName=wgx312, createdTime=Wed Sep 16 03:48:16 CST 2020, time=2020-09-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=885345, encodeId=a6c8885345ef, content=基因测序标准发布, beContent=null, objectType=article, channel=null, level=null, likeNumber=92, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0bb45125889, createdName=146465bem06暂无昵称, createdTime=Tue Sep 15 07:02:54 CST 2020, time=2020-09-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=885200, encodeId=a09f885200aa, content=科技进步很大了, beContent=null, objectType=article, channel=null, level=null, likeNumber=87, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTKibA62IFMeUJEmSyIe8DvYFeERuOsfrRd8iano7nENqQU1dRR3tqeQOUL3eqgYgEZRT2t2iaEsib0JEw/132, createdBy=66771693911, createdName=易水河, createdTime=Mon Sep 14 16:36:56 CST 2020, time=2020-09-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=885154, encodeId=93fe885154d2, content=高通量测序标准是生命科学之星, beContent=null, objectType=article, channel=null, level=null, likeNumber=94, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTJlfgys76DEiaNtbYo2re3ibjrUPTRibEXRyFwAB4aAGiave842S0FQDf0wAoaH226NiaSoPPDzhndsf1g/132, createdBy=88b489038, createdName=yangchou, createdTime=Mon Sep 14 13:19:11 CST 2020, time=2020-09-14, status=1, ipAttribution=)]
    2020-09-16 14818eb4m67暂无昵称

    学习

    0

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  6. [GetPortalCommentsPageByObjectIdResponse(id=1969447, encodeId=705a196944e92, content=<a href='/topic/show?id=6532102e6059' target=_blank style='color:#2F92EE;'>#高通量#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=99, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=102760, encryptionId=6532102e6059, topicName=高通量)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ad7f282, createdName=yang0210, createdTime=Sat May 15 07:48:16 CST 2021, time=2021-05-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1822374, encodeId=64f818223e43b, content=<a href='/topic/show?id=fb18102e6110' target=_blank style='color:#2F92EE;'>#高通量基因测序仪#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=102761, encryptionId=fb18102e6110, topicName=高通量基因测序仪)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=08e4137, createdName=meichuangyi, createdTime=Fri Dec 18 00:48:16 CST 2020, time=2020-12-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1758867, encodeId=e9a51e5886705, content=<a href='/topic/show?id=9fb76191944' target=_blank style='color:#2F92EE;'>#标准化#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=88, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=61919, encryptionId=9fb76191944, topicName=标准化)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a86337383877, createdName=108807375_62823139, createdTime=Tue Aug 24 04:48:16 CST 2021, time=2021-08-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=885638, encodeId=4bcc88563812, content=学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=80, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=64245268311, createdName=14818eb4m67暂无昵称, createdTime=Wed Sep 16 08:12:33 CST 2020, time=2020-09-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1603881, encodeId=11c5160388152, content=<a href='/topic/show?id=06353589e5e' target=_blank style='color:#2F92EE;'>#华大智造#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=82, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=35897, encryptionId=06353589e5e, topicName=华大智造)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c82d19112893, createdName=wgx312, createdTime=Wed Sep 16 03:48:16 CST 2020, time=2020-09-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=885345, encodeId=a6c8885345ef, content=基因测序标准发布, beContent=null, objectType=article, channel=null, level=null, likeNumber=92, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0bb45125889, createdName=146465bem06暂无昵称, createdTime=Tue Sep 15 07:02:54 CST 2020, time=2020-09-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=885200, encodeId=a09f885200aa, content=科技进步很大了, beContent=null, objectType=article, channel=null, level=null, likeNumber=87, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTKibA62IFMeUJEmSyIe8DvYFeERuOsfrRd8iano7nENqQU1dRR3tqeQOUL3eqgYgEZRT2t2iaEsib0JEw/132, createdBy=66771693911, createdName=易水河, createdTime=Mon Sep 14 16:36:56 CST 2020, time=2020-09-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=885154, encodeId=93fe885154d2, content=高通量测序标准是生命科学之星, beContent=null, objectType=article, channel=null, level=null, likeNumber=94, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTJlfgys76DEiaNtbYo2re3ibjrUPTRibEXRyFwAB4aAGiave842S0FQDf0wAoaH226NiaSoPPDzhndsf1g/132, createdBy=88b489038, createdName=yangchou, createdTime=Mon Sep 14 13:19:11 CST 2020, time=2020-09-14, status=1, ipAttribution=)]
    2020-09-15 146465bem06暂无昵称

    基因测序标准发布

    0

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    2020-09-14 易水河

    科技进步很大了

    0

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    2020-09-14 yangchou

    高通量测序标准是生命科学之星

    0

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