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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 2022More...
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
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