Evaluation of ECLIA antigen detection tests as screening methods for COVID-19 in comparison with molecular analysis.

Autor: Kolesova O; Department of Public Health and Infectious Diseases, University of Rome, La Sapienza, Rome, Italy.; Lifebrain Srl, Guidonia Montecelio, Viale Roma 190/A, Rome, Italy., Tomassetti F; Department of Life Sciences and Biotechnology, University of Ferrara, Ferrara, Italy.; Lifebrain Srl, Guidonia Montecelio, Viale Roma 190/A, Rome, Italy., Cerini P; Lifebrain Srl, Guidonia Montecelio, Viale Roma 190/A, Rome, Italy., Finucci D; Lifebrain Srl, Guidonia Montecelio, Viale Roma 190/A, Rome, Italy., Turchetti G; Lifebrain Srl, Guidonia Montecelio, Viale Roma 190/A, Rome, Italy., Capogreco F; Lifebrain Srl, Guidonia Montecelio, Viale Roma 190/A, Rome, Italy., Bernardini S; Department of Experimental Medicine, University of Tor Vergata, Via Montpellier 1, 00133, Rome, Italy.; Clinical Biochemistry, Tor Vergata University Hospital, Rome, Italy., Calugi G; Lifebrain Srl, Guidonia Montecelio, Viale Roma 190/A, Rome, Italy., Pieri M; Lifebrain Srl, Guidonia Montecelio, Viale Roma 190/A, Rome, Italy. massimo.pieri@uniroma2.it.; Department of Experimental Medicine, University of Tor Vergata, Via Montpellier 1, 00133, Rome, Italy. massimo.pieri@uniroma2.it.; Clinical Biochemistry, Tor Vergata University Hospital, Rome, Italy. massimo.pieri@uniroma2.it.
Jazyk: angličtina
Zdroj: Irish journal of medical science [Ir J Med Sci] 2022 Oct; Vol. 191 (5), pp. 2213-2217. Date of Electronic Publication: 2021 Nov 30.
DOI: 10.1007/s11845-021-02863-1
Abstrakt: Background: Data from literature shows that antigen tests are rapid and helpful tools for diagnosis of COVID-19.
Aim: This work aimed to evaluate the performances of the Elecsys SARS-CoV-2 Antigen test, in comparison to RT-qPCR, the gold standard.
Methods: A total of 110 swabs were tested; according to rRT-PCR, 76 were positive, and 34 were negative. The swabs were processed by Elecsys SARS CoV 2 Antigen assay (Roche Diagnostics GmbH, Mannheim, Germany), an electrochemiluminescence immunoassay (ECLIA).
Results: In a first evaluation, the overall sensitivity and specificity were 85% and 100%, respectively. It was noted that most of the discordant cases had cycle threshold (Ct) values > 28. Therefore, it was assumed a new measure to evaluate sensitivity and specificity, then samples with Ct values < 28 were selected. In this way, it was achieved a Ct < 28 sensitivity of 94%. The level of agreement between the two tests was 89. 1% with κ value of 0.77 for total data and 95.9% with κ value of 0.95 for samples with < 28 Ct. The antigen test performs well in the presence of high viral loads, whereas lower levels are missed.
Conclusions: The comparison data obtained in this study support that this method seems a proper approach for rapid screening of patients with high SARS-CoV-2 viral load; however, the rate of sensitivity is highly Ct-dependent.
(© 2021. The Author(s), under exclusive licence to Royal Academy of Medicine in Ireland.)
Databáze: MEDLINE
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