在家对呼吸道病毒的测试:对当前景观的小概述
Laura Smy1, Nathan A Ledeboer1, Macy G Wood1
1Department of Pathology, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.
Journal of clinical microbiology
|March 4, 2024
概括
无处方药 (OTC) 在家对呼吸道病毒的测试正在扩大. 尽管存在担忧,但有利的比较表明,OTC测试是医疗保健的宝贵和永久补充.
科学领域:
- 医学诊断 医学诊断 医学诊断
- 公共卫生 公共卫生
- 监管科学 监管科学
背景情况:
- 在家进行非处方 (OTC) 检测的使用已经显著增长,特别是对于呼吸道病毒.
- 美国食品和药物管理局的紧急使用授权 (EUA) 在COVID-19大流行期间促进了这些测试的广泛采用.
- 对呼吸道疾病的消费级诊断测试的可用性大幅增加.
研究的目的:
- 审查OTC呼吸道病毒测试的监管和报销环境.
- 讨论目前针对病毒性呼吸道疾病的OTC测试的可用性.
- 检查与家庭诊断测试相关的好处和缺点.
主要方法:
- 现有文献和监管框架的小审查.
- 对OTC呼吸道病毒测试当前市场的分析.
- 对OTC和实验室测试之间的比较研究的评估.
主要成果:
- 由于像 EUA 这样的监管补贴,OTC 呼吸系统病毒检测变得越来越普遍.
- 对于与用户相关的因素,如样本采集,测试性能,结果解释和报告,存在担忧.
- 对比研究表明,OTC测试结果与集中实验室的研究结果保持一致.
结论:
- 对呼吸道病毒的OTC在家检测是医疗保健的一个成熟且可能是永久的组成部分.
- 优势的比较数据支持将OTC测试纳入常规健康管理.
- 为了实现最佳利用,需要进一步考虑用户教育和公共卫生整合.
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