Clinical performance evaluation of SARS-CoV-2 rapid antigen testing in point of care usage in comparison to RT-qPCR.

Wagenhäuser, Isabell; Knies, Kerstin; Rauschenberger, Vera; Eisenmann, Michael; McDonogh, Miriam; Petri, Nils; Andres, Oliver; Flemming, Sven; Gawlik, Micha; Papsdorf, Michael; Taurines, Regina; Böhm, Hartmut; Forster, Johannes; Weismann, Dirk; Weißbrich, Benedikt; Dölken, Lars; Liese, Johannes; Kurzai, Oliver; Vogel, Ulrich; Krone, Manuel

Wagenhäuser, Isabell; Knies, Kerstin; Rauschenberger, Vera; Eisenmann, Michael; McDonogh, Miriam; Petri, Nils; Andres, Oliver; Flemming, Sven; Gawlik, Micha; Papsdorf, Michael; Taurines, Regina; Böhm, Hartmut; Forster, Johannes; Weismann, Dirk; Weißbrich, Benedikt; Dölken, Lars; Liese, Johannes; Kurzai, Oliver; Vogel, Ulrich; Krone, Manuel.

Wagenhäuser I; Institute for Hygiene and Microbiology, University of Wuerzburg, Josef-Schneider-Str. 2 / E1, Wuerzburg 97080, Germany.
Knies K; Institute for Virology and Immunobiology, University of Wuerzburg, Wuerzburg, Germany.
Rauschenberger V; Infection Control Unit, University Hospital Wuerzburg, Wuerzburg, Germany.
Eisenmann M; Infection Control Unit, University Hospital Wuerzburg, Wuerzburg, Germany.
McDonogh M; Department of Orthopaedic Trauma, Hand, Plastic and Reconstructive Surgery, University Hospital Wuerzburg, Wuerzburg, Germany.
Petri N; Department of Internal Medicine I, University Hospital Wuerzburg, Wuerzburg, Germany.
Andres O; Department of Paediatrics, University Hospital Wuerzburg, Wuerzburg, Germany.
Flemming S; Department of General, Visceral, Transplantation, Vascular and Paediatric Surgery, University Hospital Wuerzburg, Wuerzburg, Germany.
Gawlik M; Department of Psychiatry and Psychotherapy, University Hospital Wuerzburg, Wuerzburg, Germany.
Papsdorf M; Department of Obstetrics and Gynaecology, University Hospital Wuerzburg, Wuerzburg, Germany.
Taurines R; Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital Wuerzburg, Wuerzburg, Germany.
Böhm H; Department of Oral and Maxillofacial Surgery, University Hospital Wuerzburg, Wuerzburg, Germany.
Forster J; Institute for Hygiene and Microbiology, University of Wuerzburg, Josef-Schneider-Str. 2 / E1, Wuerzburg 97080, Germany.
Weismann D; Department of Internal Medicine I, University Hospital Wuerzburg, Wuerzburg, Germany.
Weißbrich B; Institute for Virology and Immunobiology, University of Wuerzburg, Wuerzburg, Germany.
Dölken L; Institute for Virology and Immunobiology, University of Wuerzburg, Wuerzburg, Germany.
Liese J; Department of Paediatrics, University Hospital Wuerzburg, Wuerzburg, Germany.
Kurzai O; 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.
Vogel U; Institute for Hygiene and Microbiology, University of Wuerzburg, Josef-Schneider-Str. 2 / E1, Wuerzburg 97080, Germany; Infection Control Unit, University Hospital Wuerzburg, Wuerzburg, Germany.
Krone M; 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. Electronic address:

EBioMedicine ; 69: 103455, 2021 Jul.

Article En | MEDLINE | ID: covidwho-1284047

Preprint
This scientific journal article is probably based on a previously available preprint. It has been identified through a machine matching algorithm, human confirmation is still pending.
See preprint

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.