SARS-CoV-2 antigen rapid detection tests: test performance during the COVID-19 pandemic and the impact of COVID-19 vaccinationResearch in context
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
Affiliations
Isabell Wagenhäuser
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
Kerstin Knies
Institute for Virology and Immunobiology, Julius-Maximilians-Universität Würzburg, Versbacher Str. 7, 97078 Würzburg, Germany
Tamara Pscheidl
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
Michael Eisenmann
Infection Control and Antimicrobial Stewardship Unit, University Hospital Würzburg, Josef-Schneider-Str. 2, 97080 Würzburg, Germany
Sven Flemming
Department of General, Visceral, Transplantation, Vascular, and Paediatric Surgery, University Hospital Würzburg, Oberdürrbacher Str. 6, 97080 Würzburg, Germany
Nils Petri
Department of Internal Medicine I, University Hospital Würzburg, Oberdürrbacher Str. 6, 97080 Würzburg, Germany
Miriam McDonogh
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
Agmal Scherzad
Department of Otorhinolaryngology, Plastic, Aesthetic, and Reconstructive Head and Neck Surgery, University Hospital Würzburg, Josef-Schneider-Str. 11, 97080 Würzburg, Germany
Daniel Zeller
Department of Neurology, University Hospital Würzburg, Josef-Schneider-Str. 11, 97080 Würzburg, Germany
Anja Gesierich
Department of Dermatology, Venerology, and Allergology, University Hospital Würzburg, Josef-Schneider-Str. 2, 97080 Würzburg, Germany
Anna Katharina Seitz
Department of Urology, University Hospital Würzburg, Oberdürrbacher Str. 6, 97080 Würzburg, Germany
Regina Taurines
Department of Child and Adolescent Psychiatry, Psychosomatics, and Psychotherapy, University Hospital Würzburg, Margarete-Höppel-Platz 1, 97080 Würzburg, Germany
Ralf-Ingo Ernestus
Department of Neurosurgery, University Hospital Würzburg, Josef-Schneider-Str. 11, 97080 Würzburg, Germany
Johannes Forster
Institute for Hygiene and Microbiology, Julius-Maximilians-Universität Würzburg, Josef-Schneider-Str. 2, 97080 Würzburg, Germany
Dirk Weismann
Department of Internal Medicine I, University Hospital Würzburg, Oberdürrbacher Str. 6, 97080 Würzburg, Germany
Benedikt Weißbrich
Institute for Virology and Immunobiology, Julius-Maximilians-Universität Würzburg, Versbacher Str. 7, 97078 Würzburg, Germany
Johannes Liese
Department of Paediatrics, University Hospital Würzburg, Josef-Schneider-Str. 2, 97080 Würzburg, Germany
Christoph Härtel
Department of Paediatrics, University Hospital Würzburg, Josef-Schneider-Str. 2, 97080 Würzburg, Germany
Oliver Kurzai
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
Lars Dölken
Institute for Virology and Immunobiology, Julius-Maximilians-Universität Würzburg, Versbacher Str. 7, 97078 Würzburg, Germany
Alexander Gabel
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
Manuel Krone
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; Corresponding author. Infection Control and Antimicrobial Stewardship Unit, University Hospital Würzburg, Josef-Schneider-Str. 2/E1, 97080 Würzburg, Germany.
Summary: 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.
