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评估SARS-CoV-2侧流装置灵敏度:系统性实验室评估与制造商报告的灵敏度的比较

Raghavendran Kulasegaran-Shylini¹, Abbie Bown², Tom Collinge³

¹Clinical and Public Health Group, UK Health Security Agency, London, UK.

EClinicalMedicine

|October 7, 2025

概括

英国独立实验室测试显示,SARS-CoV-2侧流装置 (LFD) 灵敏度存在显著的变异性,与制造商声称没有相关性. 这些发现凸显了对制造商数据的谨慎解释的必要性,并强调了对COVID-19快速测试的独立评估.

科学领域:

病毒学病毒学
公共卫生公共卫生
医学诊断医学诊断医学诊断

背景情况:

在大流行期间,使用侧流器 (LFD) 进行SARS-CoV-2自我检测至关重要.
LFD性能表现出显著的变化,需要进行独立评估.
英国卫生安全局 (UKHSA) 进行了一项综合计划,评估商业SARS-CoV-2 LFDs.

研究的目的:

独立评估商用SARS-CoV-2 LFDs的敏感性.
将UKHSA实验室评估结果与制造商报告的敏感性数据进行比较.
为了确定声称和实际LFD性能之间的差异.

主要方法:

UKHSA使用临床样本的实验室测试来评估LFD敏感性.
实验室确定的灵敏度与制造商报告的临床灵敏度和分析灵敏度 (检测极限 (LOD)) 的比较.
分析了LFD使用说明书 (IFU) 的数据.

主要成果:

由UKHSA确定的LFD敏感性差异很大,从32%到83%不等.
有相当数量的LFD (73/86) 声称临床敏感度≥85%,49声称≥95%.
在制造商报告的灵敏度或LOD与UKHSA确定的灵敏度之间没有发现相关性.

结论:

对于SARS-CoV-2 LFDs,制造商报告的性能数据应谨慎考虑.
独立的监测,测试和标准化的方法对于可靠的LFD评估至关重要.
制造商声明和独立评估之间的差异强调了严格验证的必要性.

关键词:

在 COVID-19 疫情中,侧向流量装置的侧向流量装置.这就是SARS-CoV-2病毒.

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