lancet-header

Preprints with The Lancet is part of SSRN´s First Look, a place where journals identify content of interest prior to publication. Authors have opted in at submission to The Lancet family of journals to post their preprints on Preprints with The Lancet. The usual SSRN checks and a Lancet-specific check for appropriateness and transparency have been applied. Preprints available here are not Lancet publications or necessarily under review with a Lancet journal. These preprints are early stage research papers that have not been peer-reviewed. The findings should not be used for clinical or public health decision making and should not be presented to a lay audience without highlighting that they are preliminary and have not been peer-reviewed. For more information on this collaboration, see the comments published in The Lancet about the trial period, and our decision to make this a permanent offering, or visit The Lancet´s FAQ page, and for any feedback please contact preprints@lancet.com.

SARS-CoV-2 Rapid Antigen Test Sensitivity and Viral Load in Freshly Symptomatic Hospital Employees, December 2020 to February 2022

25 Pages Posted: 3 May 2022

See all articles by Leonie Meiners

Leonie Meiners

Charité - Universitätsmedizin Berlin - Institute of Virology

Johanna Horn

Charité - Universitätsmedizin Berlin

Barbara Mühlemann

Charité - Universitätsmedizin Berlin - Institute of Virology

Marie Luisa Schmidt

Charité - Universitätsmedizin Berlin - Institute of Virology

Felix Walper

Charité - Universitätsmedizin Berlin - Institute of Virology

Peter Menzel

Labor Berlin – Charité Vivantes GmbH

Rolf Schwarzer

Labor Berlin – Charité Vivantes GmbH

Ruben Rose

Christian Albrechts-University of Kiel - Institute for Infection Medicine

Andi Krumbholz

Christian Albrechts-University of Kiel - Institute for Infection Medicine

Terry C. Jones

Charité - Universitätsmedizin Berlin - Institute of Virology

Victor M. Corman

Charité - Universitätsmedizin Berlin - Institute of Virology

Joachim Seybold

Charité - Universitätsmedizin Berlin

Christian Drosten

Charité - Universitätsmedizin Berlin - Institute of Virology

More...

Abstract

Evolving SARS-CoV-2 variants and changing levels of pre-existing immunity require re-evaluation of rapid antigen test performance. In hospital employees in Berlin, Germany, from late 2020 to early 2022, we found decreasing rapid antigen test sensitivity over time, from 80% to 67%, despite a 5·6 fold increase in median viral RNA concentrations in symptomatic employees early in their infection course. These changes were observed in parallel with a sharp increase of the percentage of employees who were at least doubly vaccinated or recovered from SARS-CoV-2 infection. Based on statistical analyses of our employee testing data set, an evaluation of antigen test performance on supernatants from SARS-CoV-2 infected cells, and rapid antigen test performance data from other studies, we hypothesize that the observed reduction in clinical rapid test sensitivity, despite higher SARS-CoV-2 RNA loads, is due to increased population immunity resulting from vaccination and prior infection.

Funding: Parts of this work were supported by grants from the Berlin University Alliance (Corona Virus Pre-Exploration Project). The study was further supported by the German Ministry of Education and Research through Forschungsnetzwerk der Universitätsmedizin zu COVID-19, (COVIM, FKZ: 01KX2021) to JS, CD, VMC; NIAID-NIH CEIRS contract HHSN272201400008C to TCJ; NaFoUniMedCovid19 (FKZ: 01KX2021) B-FAST to JS; RAPID (01KI1723A) to CD; VARIPath (01KI2021) to VMC, as well as the European Union via Project ReCoVer (grant number GA101003589) to CD. VMC is supported by the Berlin Institute of Health (BIH) Charité Clinician Scientist program.

Declaration of Interest: All authors declare no competing interests.

Ethical Approval: The study was approved by the ethics committee of Charité – Universitätsmedizin
Berlin (approval no. EA1/371/20).

Keywords: SARS-CoV-2, Diagnostic Tests, Point-of-Care Testing, COVID-19 Testing

Suggested Citation

Meiners, Leonie and Horn, Johanna and Mühlemann, Barbara and Schmidt, Marie Luisa and Walper, Felix and Menzel, Peter and Schwarzer, Rolf and Rose, Ruben and Krumbholz, Andi and Jones, Terry C. and Corman, Victor M. and Seybold, Joachim and Drosten, Christian, SARS-CoV-2 Rapid Antigen Test Sensitivity and Viral Load in Freshly Symptomatic Hospital Employees, December 2020 to February 2022. Available at SSRN: https://ssrn.com/abstract=4099425 or http://dx.doi.org/10.2139/ssrn.4099425

Leonie Meiners

Charité - Universitätsmedizin Berlin - Institute of Virology ( email )

Johanna Horn

Charité - Universitätsmedizin Berlin ( email )

Barbara Mühlemann

Charité - Universitätsmedizin Berlin - Institute of Virology ( email )

Berlin
Germany

Marie Luisa Schmidt

Charité - Universitätsmedizin Berlin - Institute of Virology ( email )

Felix Walper

Charité - Universitätsmedizin Berlin - Institute of Virology ( email )

Peter Menzel

Labor Berlin – Charité Vivantes GmbH ( email )

Rolf Schwarzer

Labor Berlin – Charité Vivantes GmbH ( email )

Germany

Ruben Rose

Christian Albrechts-University of Kiel - Institute for Infection Medicine ( email )

Germany

Andi Krumbholz

Christian Albrechts-University of Kiel - Institute for Infection Medicine

Terry C. Jones

Charité - Universitätsmedizin Berlin - Institute of Virology ( email )

Victor M. Corman

Charité - Universitätsmedizin Berlin - Institute of Virology ( email )

Joachim Seybold

Charité - Universitätsmedizin Berlin ( email )

Christian Drosten (Contact Author)

Charité - Universitätsmedizin Berlin - Institute of Virology ( email )

Berlin
Germany