澳大利亚批准COVID-19快速抗原测试用于自我测试:已发表的诊断测试准确性研究和制造商提供的信息. 一个系统的审查
Katy Jl Bell1, Yuyang Li1, Ellie Medcalf1
1School of Public Health, the University of Sydney, Sydney, NSW.
The Medical journal of Australia
|October 30, 2023
概括
澳大利亚自检COVID-19快速抗原测试 (RAT) 的诊断准确性可能被高估. 现实世界的敏感性低于制造商声称的,增加了假阴性结果的风险,并影响了感染检测可靠性.
科学领域:
- 医学诊断 医学诊断 医学诊断
- 传染病检测试验 传染病检测
- 公共卫生监督 公共卫生监督
背景情况:
- 冠状病毒疾病2019 (COVID-19) 快速抗原测试 (RAT) 已被广泛用于自我测试.
- 评估这些测试的诊断准确性对于可靠的感染检测至关重要.
- 澳大利亚的治疗药品管理局 (TGA) 批准要求遵守特定标准.
结论:
- 根据制造商的数据,自行管理的COVID-19RAT的错误阴性结果的风险可能被低估.
- 现实世界性能和制造商报告之间的差异对这些测试在排除感染的可靠性有影响.
- 对自检设备的诊断准确性数据进行进一步审查是有必要的.
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