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国外医学检验实验室自建检测方法监管现状 被引量：10

Current situation in laboratory developed tests supervision
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摘要 医学检验实验室自建检测方法（LDT）通常是指医学检验实验室自行研发、验证和使用的检测方法，仅在研发的医学检验实验室内部使用，不作为商品出售给其他医学检验实验室、医院及个人。美国食品药品管理局（FDA）监管LDT的框架指南（草案）是目前最重要的指导文件。目前各相关学术团体及专业人士对于FDA监管LDT持有不同意见。世界其他国家的LDT监管现状也值得我讯参考， Laboratory developed tests （LDT） are usually referred to the diagnostic methods for the medical laboratory, which can only be used inthe medical laboratory and can not be sold to other medical laboratories, hospitals and individuals. The paper shows the draft guideline of LDT issued by Food and Drug Administration （FDA） and the suggestions of clinical laboratory experts and relevant academic groups for different FDA monitoring models.
作者 王蓓丽 郭玮 潘柏申
机构地区 复旦大学附属中山医院检验科
出处 《中华检验医学杂志》 CAS CSCD 北大核心 2016年第1期55-59,共5页 Chinese Journal of Laboratory Medicine
关键词 临床实验室技术 质量控制 Clinical laboratory techniques Quality control
分类号 R197.3 [医药卫生—卫生事业管理]
  • 相关文献

参考文献12

  • 1Flannery E, Danzis S. FDA plans to regulate laboratory developed tests as devices. Joumal of Medical Device Regulation. [ EB/OL ]. [ 2010-8 ] . http://www, cov. corn/files/Publication/ 516fd2e9-4edc-4de0-80db-15ba723 fb51 c/Presentation/ PublicationAttachment/a5 d221 b6 -600b-4be7 -8 c0 a- 217ib00t3688/FDA% 20Plans% 20to% 20Regulate% 20Laboratory% 20Developed% 20Tests% 20as% 20Devices. pdf.
  • 2US Food and Drug Administration. Draft guidance for industry, food and drug administration staff, and clinical laboratories: framework for regulatory oversight of laboratory developed tests (LDT) . [ EB/OL] . [ 2014-10-3 ] . http://www, fda. gov/ downloads/MedicalDevices/DeviceRegulationandGuidance/ GuidanceDocuments/UCM416685. pdf.
  • 3Department of Health and Human Services, Food and DrugAdministration. Optimizing FDA's regulatory oversight of next generation sequencing diagnostic tests-preliminary discussion paper. [ EB/OL ] . [ 2014-12-9 ] http://www, fda. gov/ downloads/medicaldevices/newsevents/workshops conferences/ ucm 427869. pdf.
  • 4Department of Administration Health and Human Services, Food Center for Devices and Radiological Health. Optimizing FDA's regulatory oversight of next-generation sequencing diagnostic tests. [ EB/OL]. [2015-2-20 ]. http:// www. fda. gov/downloads/MedicalDevices/NewsEvents/ WorkshopsConferences/UC M439974. pdf.
  • 5Sharfstein J. FDA regulation of laboratory-developed diagnostic tests protect the public, advance the science. JAMA, 2015,313 : 667-668.
  • 6O' Reilly KB. FDA's LDT proposal means 'whole new ballgame' for labs. [ EB/OL ] [ 2014-10-14 ]. http:// www. captodayonline, com/fdas-ldt-proposal-means-whole-new- ballgame-labs/.
  • 7Evans JP, Watson MS. Genetic Testing and FDA Regulation Overregulation Threatens the Emergence of Genomic Medicine. JAMA, 2015, 313 : 669-670. DOI: 10. 1001/jama. 2014. 18145.
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  • 9Litwack ED, Mansfield E, Shuren J. The FDA and Genetic Testing. N Engl J Med, 2015.
  • 10Vance GH. College of American Pathologists Proposal for the Oversight of Laboratory-Developed Tests. Arch Pathol Lab Med, 2011, 135 : 1432-1435. DOI : 10. 5858/arpa. 2011-0304-SA.

同被引文献39

  • 1Flannery E, Danzis S. FDA plans to regulate laboratory developed tests as devices. Journal of Medical Device Regulation. [ EB/ OL ]. [ 2010-8 ] . http://www, coy. com/files/Publication/ 516 fd2e9-4edc-4 deO-8Odb-15 ba723 fb51 e/Presentation/ PublicationAttaehment/a5 d221 b6-600b-4be7-8cOa- 217tb00f3688/FDA% 20Plans% 20to% 20Regulate% 20Laboratory% 20Developed% 20Tests% 20as% 20Devices. pdf.
  • 2US Food and Drug Administration. Draft guidance for industry, food and drug administration staff, and clinical laboratories: framework for regulatory oversight of laboratory developed tests (LDT) . [ EB/OL ] . [ 2014-10-3 ] http ://www. fda. gov/ downloads/MedicalDevices/DeviceRegulationandGuidance/ GuidanceDocuments/U CM416685. pdf.
  • 3Department of Health and Human Services, Food and DrugAdministration. Optimizing FDA's regulatory oversight of next generation sequencing diagnostic tests-preliminary discussion paper. [ EB/OL ] . [ 2014-12-9 ] . http://www, fda. gov/ downloads/medicaldevices/newsevents/workshops conferences/ ucm 427869. pdf.
  • 4Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health Optimizing FDA' s regulatory oversight of next-generation sequencing diagnostic tests. [ EB/OL]. [2015-2-20]. http:// www. fda. gov/downloads/MedicalDevices/NewsEvents! WorkshopsConferences/UCM439974. pdf.
  • 5Shuren J, Conway PK. FDA and CMS form task force on LDT quality requirements. [ EB/OL ] . [ 2015-4-16 ] . http:// blogs, fda. gov/fdavoice/index, php/2015/04/fda-and-cms-form- task -force -on -ldt-quality -requirements/.
  • 6Emily Wasserman. FDA calls for beefed-up oversight of lab- developed tests. [ EB/OL ] . [ 2015-11-17 ] . http:// www. fiercemedicaldevices, conr/story/fda-calls-beefed-oversight- lab-developed-tests/2015 -11-17.
  • 7Tazawa Y. Perspective for the development of companion diagnostics and regulatory landscape to encourage personalized medicine in Japan. Breast Cancer, 2015, Jan 22. [ Epub ahead of print].
  • 8秦辉.欧盟体外诊断医疗器械指令(IVDD)及CE认证[J].中国医疗器械杂志,2008,32(2):153-153. 被引量：1
  • 9果伟,郭桂欣,孙川,张军,荣璋,孔国强,李文标.碳酸锂与丙戊酸在三级精神病专科医院治疗药物监测现状调查与分析[J].中国新药杂志,2013,22(11):1347-1352. 被引量：4
  • 10闫颖,张顺利,钟堃,任思楣,马嵘,王冬环,张传宝.2010～2012年度治疗药物监测室间质评结果分析[J].中国药物警戒,2013,10(12):755-759. 被引量：12

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中华检验医学杂志
2016年 第1期

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