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Open Access 01-12-2021 | SARS-CoV-2 | Original Investigation

Comparison of four commercial, automated antigen tests to detect SARS-CoV-2 variants of concern

Authors: Andreas Osterman, Maximilian Iglhaut, Andreas Lehner, Patricia Späth, Marcel Stern, Hanna Autenrieth, Maximilian Muenchhoff, Alexander Graf, Stefan Krebs, Helmut Blum, Armin Baiker, Natascha Grzimek-Koschewa, Ulrike Protzer, Lars Kaderali, Hanna-Mari Baldauf, Oliver T. Keppler

Published in: Medical Microbiology and Immunology | Issue 5-6/2021

Abstract

A versatile portfolio of diagnostic tests is essential for the containment of the severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) pandemic. Besides nucleic acid-based test systems and point-of-care (POCT) antigen (Ag) tests, quantitative, laboratory-based nucleocapsid Ag tests for SARS-CoV-2 have recently been launched. Here, we evaluated four commercial Ag tests on automated platforms and one POCT to detect SARS-CoV-2. We evaluated PCR-positive (n = 107) and PCR-negative (n = 303) respiratory swabs from asymptomatic and symptomatic patients at the end of the second pandemic wave in Germany (February–March 2021) as well as clinical isolates EU1 (B.1.117), variant of concern (VOC) Alpha (B.1.1.7) or Beta (B.1.351), which had been expanded in a biosafety level 3 laboratory. The specificities of automated SARS-CoV-2 Ag tests ranged between 97.0 and 99.7% (Lumipulse G SARS-CoV-2 Ag (Fujirebio): 97.03%, Elecsys SARS-CoV-2 Ag (Roche Diagnostics): 97.69%; LIAISON^® SARS-CoV-2 Ag (Diasorin) and SARS-CoV-2 Ag ELISA (Euroimmun): 99.67%). In this study cohort of hospitalized patients, the clinical sensitivities of tests were low, ranging from 17.76 to 52.34%, and analytical sensitivities ranged from 420,000 to 25,000,000 Geq/ml. In comparison, the detection limit of the Roche Rapid Ag Test (RAT) was 9,300,000 Geq/ml, detecting 23.58% of respiratory samples. Receiver-operating-characteristics (ROCs) and Youden’s index analyses were performed to further characterize the assays’ overall performance and determine optimal assay cutoffs for sensitivity and specificity. VOCs carrying up to four amino acid mutations in nucleocapsid were detected by all five assays with characteristics comparable to non-VOCs. In summary, automated, quantitative SARS-CoV-2 Ag tests show variable performance and are not necessarily superior to a standard POCT. The efficacy of any alternative testing strategies to complement nucleic acid-based assays must be carefully evaluated by independent laboratories prior to widespread implementation.

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Title: Comparison of four commercial, automated antigen tests to detect SARS-CoV-2 variants of concern
Authors: Andreas Osterman
Maximilian Iglhaut
Andreas Lehner
Patricia Späth
Marcel Stern
Hanna Autenrieth
Maximilian Muenchhoff
Alexander Graf
Stefan Krebs
Helmut Blum
Armin Baiker
Natascha Grzimek-Koschewa
Ulrike Protzer
Lars Kaderali
Hanna-Mari Baldauf
Oliver T. Keppler
Publication date: 01-12-2021
Publisher: Springer Berlin Heidelberg
Keyword: SARS-CoV-2
Published in: Medical Microbiology and Immunology / Issue 5-6/2021
Print ISSN: 0300-8584
Electronic ISSN: 1432-1831
DOI: https://doi.org/10.1007/s00430-021-00719-0

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