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The potential of SARS-CoV-2 antigen-detection tests in the screening of asymptomatic persons

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...

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Main Authors: Wachinger, Jonas (Author) , Olaru, Ioana D. (Author) , Horner, Susanne (Author) , Schnitzler, Paul (Author) , Heeg, Klaus (Author) , Denkinger, Claudia M. (Author)
Format: Article (Journal)
Language:English
Published: 26 July 2021
In: Clinical microbiology and infection
Year: 2021, Volume: 27, Issue: 11, Pages: 1700.e1-1700.e3
ISSN:1469-0691
DOI:10.1016/j.cmi.2021.07.020
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1016/j.cmi.2021.07.020
Verlag, lizenzpflichtig, Volltext: https://www.sciencedirect.com/science/article/pii/S1198743X21004122
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Author Notes:Jonas Wachinger, Ioana Diana Olaru, Susanne Horner, Paul Schnitzler, Klaus Heeg, Claudia M. Denkinger

MARC

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520 |a 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. 
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