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Performance of the LIAISON® SARS-CoV-2 Antigen Assay vs. SARS-CoV-2-RT-PCR

Institute for Virology, University Hospital Essen, University of Duisburg-Essen, 45147 Essen, Germany
Author to whom correspondence should be addressed.
These authors contributed equally to this work.
Academic Editor: Anna Honko
Pathogens 2021, 10(6), 658;
Received: 14 April 2021 / Revised: 14 May 2021 / Accepted: 19 May 2021 / Published: 26 May 2021
(This article belongs to the Collection SARS-CoV Infections)
We aimed to evaluate the LIAISON® SARS-CoV-2 antigen assay (DiaSorin), comparing its performance to real-time polymerase chain reaction (RT-PCR) for the detection of SARS-CoV-2 RNA. 182 (110 PCR-positive and 72 PCR-negative) nasopharyngeal swab samples were taken for the detection of SARS-CoV-2. RT-PCR and antigen assay were performed using the same material. The sensitivity and specificity of the antigen assay were calculated for different cut-offs, with RT-PCR serving as the reference method. Stored clinical samples that were positive for other respiratory viruses were tested to evaluate cross-reactivity. One third (33/110, 30%) were falsely classified as negative, while no false positives were found using the 200 TCID50/mL cut-off for the SARS-CoV-2 antigen as proposed by the manufacturer. This corresponded to a sensitivity of 70% (60–78%) and a specificity of 100% (94–100%). Lowering the cut-off for positivity of the antigen assay to 22.79 or 57.68 TCID50/mL increased the sensitivity of the method, reaching a sensitivity of 92% (85–96%) vs. 79% (70–86%) and a specificity of 81% (69–89%) vs. 99% (91–100%), respectively. The antigen assay reliably detected samples with high SARS-CoV-2 viral loads (≥106 copies SARS-CoV-2/mL), while it cannot differentiate between negative and low positive samples. Cross-reactivity toward other respiratory viruses was not detected. View Full-Text
Keywords: SARS-CoV-2; COVID-19; antigen; LIAISON® SARS-CoV-2 antigen assay; RT-PCR SARS-CoV-2; COVID-19; antigen; LIAISON® SARS-CoV-2 antigen assay; RT-PCR
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MDPI and ACS Style

Fiedler, M.; Holtkamp, C.; Dittmer, U.; Anastasiou, O.E. Performance of the LIAISON® SARS-CoV-2 Antigen Assay vs. SARS-CoV-2-RT-PCR. Pathogens 2021, 10, 658.

AMA Style

Fiedler M, Holtkamp C, Dittmer U, Anastasiou OE. Performance of the LIAISON® SARS-CoV-2 Antigen Assay vs. SARS-CoV-2-RT-PCR. Pathogens. 2021; 10(6):658.

Chicago/Turabian Style

Fiedler, Melanie, Caroline Holtkamp, Ulf Dittmer, and Olympia E. Anastasiou. 2021. "Performance of the LIAISON® SARS-CoV-2 Antigen Assay vs. SARS-CoV-2-RT-PCR" Pathogens 10, no. 6: 658.

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