Clinical performance evaluation of SARS-CoV-2 rapid antigen testing in point of care usage in comparison to RT-qPCR
Isabell Wagenhäuser,
Kerstin Knies,
Vera Rauschenberger,
Michael Eisenmann,
Miriam McDonogh,
Nils Petri,
Oliver Andres,
Sven Flemming,
Micha Gawlik,
Michael Papsdorf,
Regina Taurines,
Hartmut Böhm,
Johannes Forster,
Dirk Weismann,
Benedikt Weißbrich,
Lars Dölken,
Johannes Liese,
Oliver Kurzai,
Ulrich Vogel,
Manuel Krone
Affiliations
Isabell Wagenhäuser
Institute for Hygiene and Microbiology, University of Wuerzburg, Josef-Schneider-Str. 2 / E1, Wuerzburg 97080, Germany
Kerstin Knies
Institute for Virology and Immunobiology, University of Wuerzburg, Wuerzburg, Germany
Vera Rauschenberger
Infection Control Unit, University Hospital Wuerzburg, Wuerzburg, Germany
Michael Eisenmann
Infection Control Unit, University Hospital Wuerzburg, Wuerzburg, Germany
Miriam McDonogh
Department of Orthopaedic Trauma, Hand, Plastic and Reconstructive Surgery, University Hospital Wuerzburg, Wuerzburg, Germany
Nils Petri
Department of Internal Medicine I, University Hospital Wuerzburg, Wuerzburg, Germany
Oliver Andres
Department of Paediatrics, University Hospital Wuerzburg, Wuerzburg, Germany
Sven Flemming
Department of General, Visceral, Transplantation, Vascular and Paediatric Surgery, University Hospital Wuerzburg, Wuerzburg, Germany
Micha Gawlik
Department of Psychiatry and Psychotherapy, University Hospital Wuerzburg, Wuerzburg, Germany
Michael Papsdorf
Department of Obstetrics and Gynaecology, University Hospital Wuerzburg, Wuerzburg, Germany
Regina Taurines
Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital Wuerzburg, Wuerzburg, Germany
Hartmut Böhm
Department of Oral and Maxillofacial Surgery, University Hospital Wuerzburg, Wuerzburg, Germany
Johannes Forster
Institute for Hygiene and Microbiology, University of Wuerzburg, Josef-Schneider-Str. 2 / E1, Wuerzburg 97080, Germany
Dirk Weismann
Department of Internal Medicine I, University Hospital Wuerzburg, Wuerzburg, Germany
Benedikt Weißbrich
Institute for Virology and Immunobiology, University of Wuerzburg, Wuerzburg, Germany
Lars Dölken
Institute for Virology and Immunobiology, University of Wuerzburg, Wuerzburg, Germany
Johannes Liese
Department of Paediatrics, University Hospital Wuerzburg, Wuerzburg, Germany
Oliver Kurzai
Institute for Hygiene and Microbiology, University of Wuerzburg, Josef-Schneider-Str. 2 / E1, Wuerzburg 97080, Germany; Leibniz Institute for Natural Product Research and Infection Biology – Hans-Knoell-Institute, Jena, Germany
Ulrich Vogel
Institute for Hygiene and Microbiology, University of Wuerzburg, Josef-Schneider-Str. 2 / E1, Wuerzburg 97080, Germany; Infection Control Unit, University Hospital Wuerzburg, Wuerzburg, Germany
Manuel Krone
Institute for Hygiene and Microbiology, University of Wuerzburg, Josef-Schneider-Str. 2 / E1, Wuerzburg 97080, Germany; Infection Control Unit, University Hospital Wuerzburg, Wuerzburg, Germany; Department of Internal Medicine I, University Hospital Wuerzburg, Wuerzburg, Germany; Corresponding author at: Institute for Hygiene and Microbiology, University of Wuerzburg, Josef-Schneider-Str. 2 / E1, 97080 Wuerzburg, Germany.
Background: Antigen rapid diagnostic tests (RDT) for SARS-CoV-2 are fast, broadly available, and inexpensive. Despite this, reliable clinical performance data from large field studies is sparse.Methods: In a prospective performance evaluation study, RDT from three manufacturers (NADAL®, Panbio™, MEDsan®, conducted on different samples) were compared to quantitative reverse transcription polymerase chain reaction (RT-qPCR) in 5 068 oropharyngeal swabs for detection of SARS-CoV-2 in a hospital setting. Viral load was derived from standardised RT-qPCR Cycle threshold (Ct) values. The data collection period ranged from November 12, 2020 to February 28, 2021.Findings: The sensitivity of RDT compared to RT-qPCR was 42·57% (95% CI 33·38%–52·31%). The specificity was 99·68% (95% CI 99·48%–99·80%). Sensitivity declined with decreasing viral load from 100% in samples with a deduced viral load of ≥108 SARS-CoV-2 RNA copies per ml to 8·82% in samples with a viral load lower than 104 SARS-CoV-2 RNA copies per ml. No significant differences in sensitivity or specificity could be observed between samples with and without spike protein variant B.1.1.7. The NPV in the study cohort was 98·84%; the PPV in persons with typical COVID-19 symptoms was 97·37%, and 28·57% in persons without or with atypical symptoms.Interpretation: RDT are a reliable method to diagnose SARS-CoV-2 infection in persons with high viral load. RDT are a valuable addition to RT-qPCR testing, as they reliably detect infectious persons with high viral loads before RT-qPCR results are available.
