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

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

doi:10.1016/j.ebiom.2024.105394

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

EBioMedicine. 2024 Oct 9:109:105394. doi: 10.1016/j.ebiom.2024.105394. Online ahead of print.

Authors

Isabell Wagenhäuser¹, Kerstin Knies², Tamara Pscheidl³, Michael Eisenmann⁴, Sven Flemming⁵, Nils Petri⁶, Miriam McDonogh⁷, Agmal Scherzad⁸, Daniel Zeller⁹, Anja Gesierich¹⁰, Anna Katharina Seitz¹¹, Regina Taurines¹², Ralf-Ingo Ernestus¹³, Johannes Forster¹⁴, Dirk Weismann⁶, Benedikt Weißbrich², Johannes Liese¹⁵, Christoph Härtel¹⁵, Oliver Kurzai¹⁶, Lars Dölken², Alexander Gabel¹⁷, Manuel Krone¹⁸

Affiliations

¹ Infection Control and Antimicrobial Stewardship Unit, University Hospital Würzburg, Josef-Schneider-Str. 2, 97080 Würzburg, Germany; Department of Internal Medicine I, University Hospital Würzburg, Oberdürrbacher Str. 6, 97080 Würzburg, Germany.
² Institute for Virology and Immunobiology, Julius-Maximilians-Universität Würzburg, Versbacher Str. 7, 97078 Würzburg, Germany.
³ Infection Control and Antimicrobial Stewardship Unit, University Hospital Würzburg, Josef-Schneider-Str. 2, 97080 Würzburg, Germany; Department of Anaesthesia and Critical Care, University Hospital Würzburg, Oberdürrbacher Str. 6, 97080 Würzburg, Germany.
⁴ Infection Control and Antimicrobial Stewardship Unit, University Hospital Würzburg, Josef-Schneider-Str. 2, 97080 Würzburg, Germany.
⁵ Department of General, Visceral, Transplantation, Vascular, and Paediatric Surgery, University Hospital Würzburg, Oberdürrbacher Str. 6, 97080 Würzburg, Germany.
⁶ Department of Internal Medicine I, University Hospital Würzburg, Oberdürrbacher Str. 6, 97080 Würzburg, Germany.
⁷ Department of Anaesthesia and Critical Care, University Hospital Würzburg, Oberdürrbacher Str. 6, 97080 Würzburg, Germany; Department of Orthopaedic Trauma, Hand, Plastic, and Reconstructive Surgery, University Hospital Würzburg, Oberdürrbacher Str. 6, 97080 Würzburg, Germany.
⁸ Department of Otorhinolaryngology, Plastic, Aesthetic, and Reconstructive Head and Neck Surgery, University Hospital Würzburg, Josef-Schneider-Str. 11, 97080 Würzburg, Germany.
⁹ Department of Neurology, University Hospital Würzburg, Josef-Schneider-Str. 11, 97080 Würzburg, Germany.
¹⁰ Department of Dermatology, Venerology, and Allergology, University Hospital Würzburg, Josef-Schneider-Str. 2, 97080 Würzburg, Germany.
¹¹ Department of Urology, University Hospital Würzburg, Oberdürrbacher Str. 6, 97080 Würzburg, Germany.
¹² Department of Child and Adolescent Psychiatry, Psychosomatics, and Psychotherapy, University Hospital Würzburg, Margarete-Höppel-Platz 1, 97080 Würzburg, Germany.
¹³ Department of Neurosurgery, University Hospital Würzburg, Josef-Schneider-Str. 11, 97080 Würzburg, Germany.
¹⁴ Institute for Hygiene and Microbiology, Julius-Maximilians-Universität Würzburg, Josef-Schneider-Str. 2, 97080 Würzburg, Germany.
¹⁵ Department of Paediatrics, University Hospital Würzburg, Josef-Schneider-Str. 2, 97080 Würzburg, Germany.
¹⁶ Institute for Hygiene and Microbiology, Julius-Maximilians-Universität Würzburg, Josef-Schneider-Str. 2, 97080 Würzburg, Germany; Leibniz Institute for Natural Product Research and Infection Biology - Hans-Knoell-Institute, Beutenbergstraße 13, 07745 Jena, Germany.
¹⁷ Infection Control and Antimicrobial Stewardship Unit, University Hospital Würzburg, Josef-Schneider-Str. 2, 97080 Würzburg, Germany; Helmholtz Institute for RNA-based Infection Research (HIRI), Helmholtz Centre for Infection Research (HZI), Josef-Schneider-Str. 2, 97080 Würzburg, Germany.
¹⁸ Infection Control and Antimicrobial Stewardship Unit, University Hospital Würzburg, Josef-Schneider-Str. 2, 97080 Würzburg, Germany; Institute for Hygiene and Microbiology, Julius-Maximilians-Universität Würzburg, Josef-Schneider-Str. 2, 97080 Würzburg, Germany. Electronic address: [email protected].

PMID: 39388783
DOI: 10.1016/j.ebiom.2024.105394

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.

Keywords: COVID-19 symptoms; COVID-19 vaccination; SARS-CoV-2 rapid antigen detection test; Test performance; Viral load; Virus variants of concern.