SARS-CoV-2 antigen rapid detection tests: test performance during the COVID-19 pandemic and the impact of COVID-19 vaccination.

IF 9.7 1区医学 Q1 MEDICINE, RESEARCH & EXPERIMENTAL

EBioMedicine Pub Date : 2024-11-01 Epub Date: 2024-10-10 DOI:10.1016/j.ebiom.2024.105394

Isabell Wagenhäuser, Kerstin Knies, Tamara Pscheidl, Michael Eisenmann, Sven Flemming, Nils Petri, Miriam McDonogh, Agmal Scherzad, Daniel Zeller, Anja Gesierich, Anna Katharina Seitz, Regina Taurines, Ralf-Ingo Ernestus, Johannes Forster, Dirk Weismann, Benedikt Weißbrich, Johannes Liese, Christoph Härtel, Oliver Kurzai, Lars Dölken, Alexander Gabel, Manuel Krone

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引用次数: 0

Abstract

Background: SARS-CoV-2 antigen rapid detection tests (RDTs) emerged as point-of-care diagnostics alongside reverse transcription polymerase chain reaction (RT-qPCR) as reference.

Methods: In a prospective performance assessment from 12 November 2020 to 30 June 2023 at a single centre tertiary care hospital, the sensitivity and specificity (primary endpoints) of RDTs from three manufacturers (NADAL®, Panbio™, MEDsan®) were compared to RT-qPCR as reference standard among patients, accompanying persons and staff aged ≥ six month in large-scale, clinical screening use. Regression models were used to assess influencing factors on RDT performance (secondary endpoints).

Findings: Among 78,798 paired RDT/RT-qPCR results analysed, overall RDT sensitivity was 34.5% (695/2016; 95% CI 32.4-36.6%), specificity 99.6% (76,503/76,782; 95% CI 99.6-99.7%). Over the pandemic course, sensitivity decreased in line with a lower rate of individuals showing typical COVID-19 symptoms. The lasso regression model showed that a higher viral load and typical COVID-19 symptoms were directly significantly correlated with the likelihood of a positive RDT result in SARS-CoV-2 infection, whereas age, sex, vaccination status, and the Omicron VOC were not.

Interpretation: The decline in RDT sensitivity throughout the pandemic can primarily be attributed to the reduced prevalence of symptomatic infections among vaccinated individuals and individuals infected with Omicron VOC. RDTs remain valuable for detecting SARS-CoV-2 in symptomatic individuals and offer potential for detecting other respiratory pathogens in the post-pandemic era, underscoring their importance in infection control efforts.

Funding: German Federal Ministry of Education and Research (BMBF), Free State of Bavaria, Bavarian State Ministry of Health and Care.

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SARS-CoV-2 抗原快速检测测试：COVID-19 大流行期间的测试性能和 COVID-19 疫苗接种的影响。

背景：SARS-CoV-2抗原快速检测试剂盒（RDTs）与作为参考的反转录聚合酶链反应（RT-qPCR）一起成为护理点诊断试剂盒：方法： 2020年11月12日至2023年6月30日，在一家单中心三级护理医院进行的前瞻性性能评估中，将三个制造商（NADAL®、Panbio™、MEDsan®）生产的RDT与作为参考标准的RT-qPCR进行了比较，RT-qPCR用于大规模临床筛查中年龄≥6个月的患者、陪同人员和工作人员。采用回归模型评估 RDT 性能的影响因素（次要终点）：在分析的 78,798 份配对 RDT/RT-qPCR 结果中，RDT 的总体灵敏度为 34.5% (695/2016; 95% CI 32.4-36.6%)，特异度为 99.6% (76,503/76,782; 95% CI 99.6-99.7%)。在大流行过程中，随着出现典型 COVID-19 症状的人数减少，灵敏度也随之降低。套索回归模型显示，较高的病毒载量和典型的 COVID-19 症状与 SARS-CoV-2 感染者的 RDT 检测结果呈阳性的可能性直接显著相关，而年龄、性别、疫苗接种状况和 Omicron VOC 则不相关：在整个大流行期间，RDT 灵敏度下降的主要原因是疫苗接种者和 Omicron VOC 感染者中无症状感染的发生率降低。RDT 对于检测无症状人群中的 SARS-CoV-2 仍然很有价值，并有可能在大流行后检测其他呼吸道病原体，这凸显了 RDT 在感染控制工作中的重要性：德国联邦教育与研究部 (BMBF)、巴伐利亚自由州、巴伐利亚州卫生与保健部。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

EBioMedicine Biochemistry, Genetics and Molecular Biology-General Biochemistry,Genetics and Molecular Biology

CiteScore

17.70

自引率

0.90%

发文量

579

审稿时长

5 weeks

期刊介绍： eBioMedicine is a comprehensive biomedical research journal that covers a wide range of studies that are relevant to human health. Our focus is on original research that explores the fundamental factors influencing human health and disease, including the discovery of new therapeutic targets and treatments, the identification of biomarkers and diagnostic tools, and the investigation and modification of disease pathways and mechanisms. We welcome studies from any biomedical discipline that contribute to our understanding of disease and aim to improve human health.