构建SARS-CoV-2紧急使用授权诊断数据的挑战:利用可查找,可访问,可互操作和可重复使用的原则为下一个诊断数据透明的时代
Archives of pathology & laboratory medicine
|December 12, 2025
概括
美国食品和药物管理局.
科学领域:
- 医学诊断 医学诊断 医学诊断
- 监管科学 监管科学
- 数据科学数据科学数据科学
背景情况:
- 美国食品和药物管理局 (FDA) 发布了SARS-CoV-2测试的紧急使用授权 (EUA).
- 在FDA网站上以PDF文件的形式发布了EUA数据和文件,创造了一个有价值的数据资源.
研究的目的:
- 强调SARS-CoV-2诊断测试结构化数据的重要性.
- 为提高FDA数字资源的质量,可访问性和可共享性提供建议.
主要方法:
- 从FDA获得了SARS-CoV-2诊断EUA和相关文件.
- 通过质量保证的手动或自动化流程提取数据.
- 为传播生成数据产品,包括数据分析和表格,图表和报告中的呈现.
主要成果:
- 确定了阻碍FDA EUA数据可用性的四个关键挑战:测试名称模糊性,文件跟踪不一致,数据结构异质,以及由于修改沟通不清楚而导致数据维护的困难.
- 类似的测试名称和不一致的命名惯例使得区分 EUA 测试变得困难.
- 不一致的文档标识符,定位器和版本复杂的文档跟踪.
- 在 EUA 文档中异构的数据结构和格式化阻碍了数据检索.
- 由于缺乏关于 EUA 修改的明确沟通,因此数据维护具有挑战性.
结论:
- 合成FDA测试数据突出了改善数据组织和通信的关键需求.
- 现有的FDA数据报告系统需要改进,以满足数据科学时代的需求.
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