BEAVER与PTB合作纳米磁珠国际标准顺利进入委员会文件阶段

由苏州海狸公司(BEAVER)与德国联邦物理技术研究院(PTB)联合主导的国际标准ISO/TS 19807-2 “纳米技术 – 磁性纳米材料 第2部分 – 核酸提取用纳米结构超顺磁性磁珠 – 特性和测量方法”,于2019年5月16日在澳大利亚悉尼举办的国际标准化组织纳米技术委员会材料规格工作组(ISO/TC229/WG4)年会上,经过各国专家的热烈讨论,达成共识,顺利进入委员会文件(CD)阶段。

 

 

该项目2016年5月在日本京都举办的ISO/TC229/WG4年会上进行立项陈述,2018年9月正式通过新项目投票(NWIP),计划于2021年9月发布。作为纳米磁珠技术系列国际标准的第二部分,本标准规范了用于核酸提取的纳米超顺磁性磁珠的重要特性,并列出了每种重要特性的测量方法。超顺磁性纳米磁珠作为当前生物医学工程和精准医疗领域广泛应用的核心原材料,质量控制和测量方法的统一至关重要,其国际标准引起了各国专家的高度关注,来自中国、德国、美国、韩国、日本、英国、奥地利、伊朗、卢森堡等十多个国家的学术界和工业界专家对本项目草案提出了500余个问题及建议,对本项目的日臻完善打下基础。

 

 

本项目由BEAVER与德国PTB联合主导,并在全国纳米技术标准化技术委员会(SAC/TC279)副主任委员、国家纳米科学中心葛广路研究员及团队的指导下开展,项目共同负责人分别为BEAVER创始人任辉博士和德国PTB科学家、欧盟MagNaStand项目负责人Uwe Steinhoff博士。本项目不仅让中国生物工程材料自主品牌有机会参与到国际标准的制定工作中,同时也加强了中德学术界和工业界在纳米磁珠领域的交流与合作。德国标准化协会(DIN)近期在其网站上对本项目的进展给予了专门的报道。

附原文:

ISO / TS 19807-2 “Nanotechnologies – Magnetic nanomaterials – Part 2: Specification of characteristics and measurements for nanostructured superparamagnetic beads for nucleic acid extraction” is prepared in ISO / TC 229 “Nanotechnologies” under joint Chinese and German project management.

The standardization project was accepted by ISO / TC 229 in September 2018 as an active standardization project and will be developed with a project duration of 3 years, probably until September 2021. Essential contents of ISO / TS 19807-2 will be included in the EMPIR project MagNaStand, whose project leader is the co-project leader of the standardization project and in which DIN participates as a project partner. The Technical Specification defines features and measurement methods for nanoscale superparamagnetic spheres used for DNA or RNA extraction. ctDNA extraction (extraction of circulating free tumor DNA) is one of the most widely used biopsy methods for the detection of cancer and the progression of cancer development. Because ctDNA accounts for only a small fraction of total cell-free DNA in the blood, a very accurate extraction procedure is needed, for which nanoscale superparamagnetic beads are helpful. The various forms of superparamagnetic spheres and suspension media have different physico-chemical properties which affect extraction to varying degrees. The use of well-characterized nanoscale superparamagnetic spheres is very important in this context.

(转自海狸生物)