1. The potential of SARS-CoV-2 antigen-detection tests in the screening of asymptomatic persons.
- Author
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Wachinger J, Olaru ID, Horner S, Schnitzler P, Heeg K, and Denkinger CM
- Subjects
- COVID-19 Testing methods, Diagnostic Tests, Routine, Germany, Humans, Predictive Value of Tests, Sensitivity and Specificity, Tertiary Healthcare, Antigens, Viral isolation & purification, COVID-19 diagnosis, Mass Screening methods, SARS-CoV-2 isolation & purification
- Abstract
Objectives: The aim was to assess the performance of antigen-based rapid diagnostic tests (Ag-RDTs) for SARS CoV-2 when implemented for large-scale universal screening of asymptomatic individuals., Methods: This study was a pragmatic implementation study for universal Ag-RDT-based screening at a tertiary care hospital in Germany where patients presenting for elective procedures and selected personnel without symptoms suggestive of SARS-CoV-2 were screened with an Ag-RDT since October 2020. Test performance was calculated on an individual patient level., Results: In total, 49 542 RDTs were performed in 27 421 asymptomatic individuals over a duration of 5 and a half months. Out of 222 positive results, 196 underwent in-house confirmatory testing with PCR, out of which 170 were confirmed positive, indicating a positive predictive value of 86.7% (95% CI 81.2-91.1%). Negative Ag-RDTs were not routinely tested with PCR, but a total of 94 cases of false negative Ag-RDTs were detected due to PCR tests being performed within the following 5 days with a median cycle threshold value of 33 (IQR 29-35)., Discussion: This study provides evidence that Ag-RDTs can have a high diagnostic yield for transmission relevant infections with limited false positives when utilized at the point of care on asymptomatic patients and thus can be a suitable public health test for universal screening., (Copyright © 2021 The Author(s). Published by Elsevier Ltd.. All rights reserved.)
- Published
- 2021
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