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

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

Journal

EBioMedicine
ISSN: 2352-3964
Titre abrégé: EBioMedicine
Pays: Netherlands
ID NLM: 101647039

Informations de publication

Date de publication:
09 Oct 2024
Historique:
received: 17 04 2024
revised: 23 09 2024
accepted: 26 09 2024
medline: 11 10 2024
pubmed: 11 10 2024
entrez: 10 10 2024
Statut: aheadofprint

Résumé

SARS-CoV-2 antigen rapid detection tests (RDTs) emerged as point-of-care diagnostics alongside reverse transcription polymerase chain reaction (RT-qPCR) as reference. 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). 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. 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. German Federal Ministry of Education and Research (BMBF), Free State of Bavaria, Bavarian State Ministry of Health and Care.

Sections du résumé

BACKGROUND 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 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 RESULTS
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 CONCLUSIONS
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 BACKGROUND
German Federal Ministry of Education and Research (BMBF), Free State of Bavaria, Bavarian State Ministry of Health and Care.

Identifiants

DOI: 10.1016/j.ebiom.2024.105394 PMID: 39388783
pubmed: 39388783
pii: S2352-3964(24)00430-4
doi: 10.1016/j.ebiom.2024.105394
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

105394

Informations de copyright

Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of interests Daniel Zeller receives honoraria from Angelini Pharma and Novartis outside of the submitted work. Manuel Krone receives honoraria from Abbott, GSK, Pfizer, and Sanofi outside of the submitted work. None of the other authors have any conflicts of interest to declare.

Auteurs

Isabell Wagenhäuser (I)

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 (K)

Institute for Virology and Immunobiology, Julius-Maximilians-Universität Würzburg, Versbacher Str. 7, 97078 Würzburg, Germany.

Tamara Pscheidl (T)

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 (M)

Infection Control and Antimicrobial Stewardship Unit, University Hospital Würzburg, Josef-Schneider-Str. 2, 97080 Würzburg, Germany.

Sven Flemming (S)

Department of General, Visceral, Transplantation, Vascular, and Paediatric Surgery, University Hospital Würzburg, Oberdürrbacher Str. 6, 97080 Würzburg, Germany.

Nils Petri (N)

Department of Internal Medicine I, University Hospital Würzburg, Oberdürrbacher Str. 6, 97080 Würzburg, Germany.

Miriam McDonogh (M)

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 (A)

Department of Otorhinolaryngology, Plastic, Aesthetic, and Reconstructive Head and Neck Surgery, University Hospital Würzburg, Josef-Schneider-Str. 11, 97080 Würzburg, Germany.

Daniel Zeller (D)

Department of Neurology, University Hospital Würzburg, Josef-Schneider-Str. 11, 97080 Würzburg, Germany.

Anja Gesierich (A)

Department of Dermatology, Venerology, and Allergology, University Hospital Würzburg, Josef-Schneider-Str. 2, 97080 Würzburg, Germany.

Anna Katharina Seitz (AK)

Department of Urology, University Hospital Würzburg, Oberdürrbacher Str. 6, 97080 Würzburg, Germany.

Regina Taurines (R)

Department of Child and Adolescent Psychiatry, Psychosomatics, and Psychotherapy, University Hospital Würzburg, Margarete-Höppel-Platz 1, 97080 Würzburg, Germany.

Ralf-Ingo Ernestus (RI)

Department of Neurosurgery, University Hospital Würzburg, Josef-Schneider-Str. 11, 97080 Würzburg, Germany.

Johannes Forster (J)

Institute for Hygiene and Microbiology, Julius-Maximilians-Universität Würzburg, Josef-Schneider-Str. 2, 97080 Würzburg, Germany.

Dirk Weismann (D)

Department of Internal Medicine I, University Hospital Würzburg, Oberdürrbacher Str. 6, 97080 Würzburg, Germany.

Benedikt Weißbrich (B)

Institute for Virology and Immunobiology, Julius-Maximilians-Universität Würzburg, Versbacher Str. 7, 97078 Würzburg, Germany.

Johannes Liese (J)

Department of Paediatrics, University Hospital Würzburg, Josef-Schneider-Str. 2, 97080 Würzburg, Germany.

Christoph Härtel (C)

Department of Paediatrics, University Hospital Würzburg, Josef-Schneider-Str. 2, 97080 Würzburg, Germany.

Oliver Kurzai (O)

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 (L)

Institute for Virology and Immunobiology, Julius-Maximilians-Universität Würzburg, Versbacher Str. 7, 97078 Würzburg, Germany.

Alexander Gabel (A)

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 (M)

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: krone_m@ukw.de.

Classifications MeSH