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China Biotechnology. 2020, (12) Core

Key Points of Assay Cut-off and Reference Interval for In vitro Diagnostic ReagentsChinese Full TextEnglish Full Text (MT)

BAO Wen;

Abstract: ＜正＞我国体外诊断产业正处于蓬勃发展的阶段,积累了一定的技术基础,但尚存在产品设计开发过程不规范等问题。如何在符合我国国情的前提下,指导企业科学合理的开展体外诊断试剂的设计和开发成为亟待解决的问题。这就要求企业不仅应重视临床性能的评价,也需系统而全面地进行分析性能的研究,以综合评价产品的安全有效性;其中关键的项目之一为定性检测试剂的阳性判断值或定量检测试剂的参考区间。 
  • DOI：

    10.13523/j.cb.2007044

  • Series：

    (A) Mathematics/ Physics/ Mechanics/ Astronomy; (E) Medicine ＆ Public Health

  • Subject：

    Pharmaceutics

  • Classification Code：

    R95

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