DGHM
EINE STARKE GEMEINSCHAFT

Virus variant specific clinical performance of SARS-CoV-2 rapid antigen tests in point-of-care use, November 2020 to January 2022

Clinical Microbiology and Infection, 2022

Link zum vollständigen Artikel: https://pubmed.ncbi.nlm.nih.gov/36028089/

Autorin: Isabel Wagenhäuser

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

Methods
This single-center prospective performance assessment compares RDT from three manufacturers (NADAL®, Panbio™, MEDsan®) with RT-qPCR including deduced standardised viral load from oropharyngeal swabs for detection of SARS-CoV-2 in a clinical point-of-care setting from November 2020 to January 2022.

Results
Among 35,479 RDT/RT-qPCR tandems taken from 26,940 individuals, 164 of the 426 SARS-CoV-2 positive samples tested true positive by RDT corresponding to a 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 42.86% (95% CI 32.82%–53.52%) for wild-type SARS-CoV-2, 43.42% (95% CI 32.86%–54.61%) for Alpha VOC, 37.67% (95% CI 30.22%–45.75%) for Delta VOC, and 33.67% (95% CI 25.09%–43.49%) for Omicron VOC. Sensitivity in samples with high viral loads ≥106 SARS-CoV-2 RNA copies per ml was significantly lower in Omicron VOC (50.00%, 95% CI 36.12%–63.88%) compared to wild-type SARS-CoV-2 (79.31%, 95% CI 61.61%–90.15%, p=0.015).

Conclusion
RDT sensitivity for detection of the Omicron VOC is reduced in infectious individuals with high viral load, which curtails the effectiveness of RDT. This aspect further limits RDT use although RDT are still an irreplaceable diagnostic tool for rapid, economic, point-of-care and extensive SARS-CoV-2 screening use.

Kommentar:
In der bisher weltweit größten veröffentlichten klinischen Studie zu SARS-CoV-2 Antigen-Schnelltests konnte erstmals ausgehend von 35 479 Antigen-Schnelltests mit paralleler PCR als Referenzmethode im Kontext der verschiedenen SARS-CoV-2 variants of concern, allen voran für die Omikron-Variante, untersucht werden. Von 426 SARS-CoV-2-positiven PCR-Proben waren im Schnelltest nur 164 positiv. Das entspricht einer Sensitivität von lediglich 38,50 Prozent. Bei der derzeit vorherrschenden Omikron-Variante schlugen sogar nur 33,67 Prozent an. Beim Wildtyp zeigten immerhin 42,86 Prozent der Schnelltests einen positiven Befund. Mit der präsentierten Analyse konnte somit die geminderte Antigen-Schnelltests Sensitivität gegenüber der Omikron-Variante, die zuvor bereits in Laboranalysen berichtet wurde, erstmalig in der klinischen Routine gezeigt werden, was mit hoher Übertragbarkeit im Rahmen der weiterhin dynamischen COVID-19 Pandemie von großer praktischer Relevanz ist.

Kontakt:
Isabell Wagenhäuser
Universitätsklinikum Würzburg
Zentrale Einrichtung Krankenhaushygiene und Antimicrobial Stewardship
Josef-Schneider-Str. 2 / E1
97080 Würzburg
wagenhaeu_i@ukw.de

Autor:inneninformationen:

• ¹ Infection Control and Antimicrobial Stewardship Unit, University Hospital Wuerzburg, Wuerzburg, Germany.
• ² Institute for Virology and Immunobiology, University of Wuerzburg, Wuerzburg, Germany.
• ³ Infection Control and Antimicrobial Stewardship Unit, University Hospital Wuerzburg, Wuerzburg, Germany; Institute for Hygiene and Microbiology, University of Wuerzburg, Wuerzburg, Germany.
• ⁴ Department of General, Visceral, Transplantation, Vascular and Paediatric Surgery, University Hospital Wuerzburg, Wuerzburg, Germany.
• ⁵ Department of Paediatrics, University Hospital Wuerzburg, Wuerzburg, Germany.
• ⁶ Department of Internal Medicine I, University Hospital Wuerzburg, Wuerzburg, Germany.
• ⁷ Department of Internal Medicine II, University Hospital Wuerzburg, Wuerzburg, Germany.
• ⁸ Department of Obstetrics and Gynaecology, University Hospital Wuerzburg, Wuerzburg, Germany.
• ⁹ Department of Orthopaedic Trauma, Hand, Plastic and Reconstructive Surgery, University Hospital Wuerzburg, Wuerzburg, Germany.
• ¹⁰ Department of Ophthalmology, University Hospital Wuerzburg, Wuerzburg, Germany.
• ¹¹ Department of Otorhinolaryngology, Plastic, Aesthetic and Reconstructive Head and Neck Surgery, University Hospital Wuerzburg, Wuerzburg, Germany.
• ¹² Department of Neurology, University Hospital Wuerzburg, Wuerzburg, Germany.
• ¹³ Department of Oral and Maxillofacial Surgery, University Hospital Wuerzburg, Wuerzburg, Germany.
• ¹⁴ Department of Dermatology, Venerology and Allergology, University Hospital Wuerzburg, Wuerzburg, Germany.
• ¹⁵ Department of Urology, University Hospital Wuerzburg, Wuerzburg, Germany.
• ¹⁶ Department of Neurosurgery, University Hospital Wuerzburg, Wuerzburg, Germany.
• ¹⁷ Department of Psychiatry and Psychotherapy, University Hospital Wuerzburg, Wuerzburg, Germany.
• ¹⁸ Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital Wuerzburg, Wuerzburg, Germany.
• ¹⁹ Department of Anaesthesia and Critical Care, University Hospital Wuerzburg, Wuerzburg, Germany.
• ²⁰ Institute for Hygiene and Microbiology, University of Wuerzburg, Wuerzburg, Germany.
• ²¹ Institute of Bioinformatics, University Medicine Greifswald, Greifswald, Germany.
• ²² Institute for Hygiene and Microbiology, University of Wuerzburg, Wuerzburg, Germany; Leibniz Institute for Natural Product Research and Infection Biology-Hans-Knoell-Institute, Jena, Germany.
• ²³ Infection 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.

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