Evidence map›Paper›PMID 36028089›Full record

ArticleClinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases2023

Virus variant-specific clinical performance of SARS coronavirus two rapid antigen tests in point-of-care use, from November 2020 to January 2022.

Isabell Wagenhäuser, Kerstin Knies, Daniela Hofmann, Vera Rauschenberger, Michael Eisenmann, Julia Reusch, Alexander Gabel, Sven Flemming, Oliver Andres, Nils Petri and 23 more

Abstract read
In one paragraph

Article in Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

24 citing papers in PubMed.

  1. Virologic Response and Safety of Ibuzatrelvir, A Novel SARS-CoV-2 Antiviral, in Adults With COVID-19.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
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  12. Review
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  14. The Sensitivity of Rapid Tests for SARS-CoV-2 Antigen.Deutsches Arzteblatt international · 2023
    Article
  15. Development of practical techniques for simultaneous detection and distinction of current and emerging SARS-CoV-2 variants.Analytical sciences : the international journal of the Japan Society for Analytical Chemistry · 2023
    Review
  16. Article
  17. Article
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  19. Virus variant-specific clinical performance of a SARS-CoV-2 rapid antigen test with focus on Omicron variants of concern.Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases · 2023
    Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

33 authors.

Isabell WagenhäuserInfection Control and Antimicrobial Stewardship Unit, University Hospital Wuerzburg, Wuerzburg, Germany.
Kerstin KniesInstitute for Virology and Immunobiology, University of Wuerzburg, Wuerzburg, Germany.
Daniela HofmannInstitute for Virology and Immunobiology, University of Wuerzburg, Wuerzburg, Germany.
Vera RauschenbergerInfection Control and Antimicrobial Stewardship Unit, University Hospital Wuerzburg, Wuerzburg, Germany; Institute for Hygiene and Microbiology, University of Wuerzburg, Wuerzburg, Germany.
Michael EisenmannInfection Control and Antimicrobial Stewardship Unit, University Hospital Wuerzburg, Wuerzburg, Germany.
Julia ReuschInfection Control and Antimicrobial Stewardship Unit, University Hospital Wuerzburg, Wuerzburg, Germany.
Alexander GabelInfection Control and Antimicrobial Stewardship Unit, University Hospital Wuerzburg, Wuerzburg, Germany.
Sven FlemmingDepartment of General, Visceral, Transplantation, Vascular and Paediatric Surgery, University Hospital Wuerzburg, Wuerzburg, Germany.
Oliver AndresDepartment of Paediatrics, University Hospital Wuerzburg, Wuerzburg, Germany.
Nils PetriDepartment of Internal Medicine I, University Hospital Wuerzburg, Wuerzburg, Germany.
Max S ToppDepartment of Internal Medicine II, University Hospital Wuerzburg, Wuerzburg, Germany.
Michael PapsdorfDepartment of Obstetrics and Gynaecology, University Hospital Wuerzburg, Wuerzburg, Germany.
Miriam McDonoghDepartment of Orthopaedic Trauma, Hand, Plastic and Reconstructive Surgery, University Hospital Wuerzburg, Wuerzburg, Germany.
Raoul Verma-FühringDepartment of Ophthalmology, University Hospital Wuerzburg, Wuerzburg, Germany.
Agmal ScherzadDepartment of Otorhinolaryngology, Plastic, Aesthetic and Reconstructive Head and Neck Surgery, University Hospital Wuerzburg, Wuerzburg, Germany.
Daniel ZellerDepartment of Neurology, University Hospital Wuerzburg, Wuerzburg, Germany.
Hartmut BöhmDepartment of Oral and Maxillofacial Surgery, University Hospital Wuerzburg, Wuerzburg, Germany.
Anja GesierichDepartment of Dermatology, Venerology and Allergology, University Hospital Wuerzburg, Wuerzburg, Germany.
Anna K SeitzDepartment of Urology, University Hospital Wuerzburg, Wuerzburg, Germany.
Michael KiderlenDepartment of Neurosurgery, University Hospital Wuerzburg, Wuerzburg, Germany.
Micha GawlikDepartment of Psychiatry and Psychotherapy, University Hospital Wuerzburg, Wuerzburg, Germany.
Regina TaurinesDepartment of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital Wuerzburg, Wuerzburg, Germany.
Thomas WurmbDepartment of Anaesthesia and Critical Care, University Hospital Wuerzburg, Wuerzburg, Germany.
Ralf-Ingo ErnestusDepartment of Neurosurgery, University Hospital Wuerzburg, Wuerzburg, Germany.
Johannes ForsterInstitute for Hygiene and Microbiology, University of Wuerzburg, Wuerzburg, Germany.
Dirk WeismannDepartment of Internal Medicine I, University Hospital Wuerzburg, Wuerzburg, Germany.
Benedikt WeißbrichInstitute for Virology and Immunobiology, University of Wuerzburg, Wuerzburg, Germany.
Lars DölkenInstitute for Virology and Immunobiology, University of Wuerzburg, Wuerzburg, Germany.
Johannes LieseDepartment of Paediatrics, University Hospital Wuerzburg, Wuerzburg, Germany.
Lars KaderaliInstitute of Bioinformatics, University Medicine Greifswald, Greifswald, Germany.
Oliver KurzaiInstitute for Hygiene and Microbiology, University of Wuerzburg, Wuerzburg, Germany; Leibniz Institute for Natural Product Research and Infection Biology-Hans-Knoell-Institute, Jena, Germany.
Ulrich VogelInfection Control and Antimicrobial Stewardship Unit, University Hospital Wuerzburg, Wuerzburg, Germany; Institute for Hygiene and Microbiology, University of Wuerzburg, Wuerzburg, Germany.
Manuel KroneInfection Control and Antimicrobial Stewardship Unit, University Hospital Wuerzburg, Wuerzburg, Germany; Institute for Hygiene and Microbiology, University of Wuerzburg, Wuerzburg, Germany; Department of Internal Medicine I, University Hospital Wuerzburg, Wuerzburg, Germany. Electronic address: krone_m@ukw.de.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesAntigen rapid diagnostic tests (RDTs) for SARS coronavirus 2 (SARS-CoV-2) are quick, widely available, and inexpensive. Consequently, RDTs have been established as an alternative and additional diagnostic strategy to quantitative reverse transcription polymerase chain reaction (RT-qPCR). However, reliable clinical and large-scale performance data specific to a SARS-CoV-2 virus variant of concern (VOC) are limited, especially for the Omicron VOC. The aim of this study was to compare RDT performance among different VOCs.

methodsThis single-centre prospective performance assessment compared RDTs from three manufacturers (NADAL, Panbio, MEDsan) with RT-qPCR including deduced standardized viral load from oropharyngeal swabs for detection of SARS-CoV-2 in a clinical point-of-care setting from November 2020 to January 2022.

resultsAmong 35 479 RDT/RT-qPCR tandems taken from 26 940 individuals, 164 of the 426 SARS-CoV-2 positive samples tested true positive with an RDT corresponding to an RDT sensitivity of 38.50% (95% CI, 34.00-43.20%), with an overall specificity of 99.67% (95% CI, 99.60-99.72%). RDT sensitivity depended on viral load, with decreasing sensitivity accompanied by descending viral load. VOC-dependent sensitivity assessment showed a sensitivity of 42.86% (95% CI, 32.82-53.52%) for the wild-type SARS-CoV-2, 43.42% (95% CI, 32.86-54.61%) for the Alpha VOC, 37.67% (95% CI, 30.22-45.75%) for the Delta VOC, and 33.67% (95% CI, 25.09-43.49%) for the Omicron VOC. Sensitivity in samples with high viral loads of ≥10 DISCUSSION: RDT sensitivity for detection of the Omicron VOC is reduced in individuals infected with a high viral load, which curtails the effectiveness of RDTs. This aspect furthert: limits the use of RDTs, although RDTs are still an irreplaceable diagnostic tool for rapid, economic point-of-care and extensive SARS-CoV-2 screening.

Indexed as

COVID-19Point-of-Care SystemsHumansProspective StudiesRNA, ViralSARS-CoV-2Sensitivity and SpecificityRNA, ViralAntigen rapid diagnostic testClinical performance evaluationOmicronPCRSARS-CoV-2Virus variants of concern

Identifiers

PMID36028089
PMCPMC9398563

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.