针对SARS-CoV-2的快速抗原测试的诊断性能:COVid-19抗原 (COVAG) 扩展研究
Christoph Wertenauer1,2,3, Alexander Dressel4, Eberhard Wieland5
1Medical Clinic V, Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany.
Frontiers in medicine
|May 3, 2024
概括
快速抗原测试 (RATs) 显示检测SARS-CoV-2变种的灵敏度较低,特别是在无症状个体和以前患有COVID-19的人群中. 敏感性随着Ct值较低而增加,表明病毒载量较高.
科学领域:
- 传染性疾病 传染性疾病
- 病毒学 病毒学
- 诊断测试 诊断测试 诊断测试
背景情况:
- 这项研究扩展了COVAG研究,比较了Panbio COVID-19 Ag快速测试 (Abbott) 和SD Biosensor Q SARS-CoV-2快速抗原测试 (Roche).
- 在新出现的SARS-CoV-2变种的背景下,对RT-PCR进行了评估.
研究的目的:
- 评估SARS-CoV-2的两个快速抗原测试 (RAT) 的诊断性能.
- 为了比较Abbott-RAT和Roche-RAT对RT-PCR的敏感性和特异性.
- 调查影响RAT敏感性的因素,包括病毒变异,CT值和参与者特征.
主要方法:
- 在2021年10月至2022年3月期间,888名参与者在诊断中心注册.
- 对RT-PCR阳性样本 (Ct ≤32) 进行了SARS-CoV-2变异的分析.
- 计算了Abbott-RAT和Roche-RAT的灵敏度和特异性,并与Ct值,症状,疫苗接种状态和变体相关联.
主要成果:
- 阿博特-RAT和罗氏-RAT的总体灵敏度分别为65%和67%,特异性>99%.
- 灵敏度与较低的Ct值显著相关,Ct ≤25最高 (95-96%),Ct ≥30最低 (2-6%).
- 在有症状的个体 (76-77%) 与无症状 (29-31%) 和由初级保健医生 (84-85%) 测试的人群中观察到更高的敏感性. 与没有COVID-19的人 (73-75%) 相比,先前COVID-19患者 (27-31%) 的敏感性明显较低.
- 奥米克朗和三角洲变种显示出高灵敏度 (80-94%),而阿尔法变种显示出显著较低的灵敏度.
- 疫苗接种状态和测试灵敏度之间没有发现显著的相关性.
结论:
- 快速抗原测试显示了SARS-CoV-2检测的可变灵敏度,受病毒载量 (Ct值),症状状态和先前感染史的影响.
- 虽然特异性仍然很高,但某些子组和特定变异的敏感性降低凸显了需要仔细解释RAT结果的必要性.
- 性能差异强调了在利用快速抗原测试用于COVID-19诊断时考虑临床背景和病毒特征的重要性.
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