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德国人类遗传学和实验室医学中心成功获得无创产前诊断的ISO认可

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近日,来自德国人类遗传学和实验室医学中心的研究人员表示,他们名为Prenatalis的无创产前诊断技术(NIPT)已经收到了ISO 15189:2014的认证。

  近日,来自德国人类遗传学和实验室医学中心的研究人员表示,他们名为Prenatalis的无创产前诊断技术(NIPT)已经收到了ISO 15189:2014的认证。
  德国认证机构认为这项无创产前诊断技术是德国检测三染色体21、18和13来满足德国国家认可委员会(DAkkS)要求的首个技术,研究者指出,目前国家认可委员会评估了无创产前诊断技术的产品、过程、服务及整个系统的质量和准确性,整个认证过程成功完美地通过再次证明了人类遗传学和实验室医学中心的技术和医学能力。
  Prenatalis是基于Illumina公司Verifi NIPT的技术开发的,在德国和Illumina的合作下,目前已经在德国马丁雷德的中心实验室建立并且已经经过了验证;就在上周,来自英国的伯明翰妇女国家医疗服务系统基金会就表示他们正在同Illumina公司合作开发新型的无创产前诊断技术。(转化医学网360zhyx.com)
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转化医学网推荐的新闻阅读:

 German Lab Receives ISO Accreditation for NIPT 

The Center for Human Genetics and Laboratory Medicine today announced that its Prenatalis non-invasive prenatal test has received ISO 15189:2014 accreditation.  

The designation by the German Accreditation Body (DAkkS) makes the test the first inGermanydetecting trisomies 21, 18, and 13 to meet the requirements of DAkkS, the center said. DAkkS evaluates the quality and accuracy of products, processes, services, and systems. Successful completion of the accreditation process demonstrates technical and medical competence of the lab, the center said.  

Prenatalis is based on Illumina' Verifi NIPT technology and was established and validated at the center's laboratory in Martinsried, Germany in cooperation with Illumina. Last week, the UK's Birmingham Women's NHS Foundation Trust said it was partnering with Illumina to develop an NIPT.  


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