Objective We assessed the clinical performance of novel Roche Elecsys SARS-CoV-2 Antigen fully automated electrochemiluminescence immunoassay (ECLIA). Design and methods We tested 160 subjects, 110 (68.8%) with positive molecular test for SARS-CoV-2 infection in nasopharyngeal samples with Altona Diagnostics RealStar SARS-CoV-2 RT-PCR Kit and Roche Elecsys SARS-CoV-2 Antigen. Results Highly significant correlation was found between Elecsys SARS-CoV-2 Antigen ECLIA and cycle threshold (Ct) values of SARS-CoV-2 S and E genes (both r = −0.91; p < 0.001). The area under the curve (AUC), sensitivity and specificity of Elecsys SARS-CoV-2 Antigen ECLIA were 0.83, 0.43 and 1.00 in all samples, 0.99, 0.87 and 0.99 in those with both Ct values < 30, as well as 1.00, 1.00 and 0.89 in samples with both Ct values < 25. Conclusion Roche Elecsys SARS-CoV-2 Antigen ECLIA may be a surrogate of molecular testing for identification of super-spreaders.

Clinical performance of the Roche Elecsys SARS-CoV-2 antigen fully automated electrochemiluminescence immunoassay

Salvagno, Gian Luca;Pighi, Laura;De Nitto, Simone;Lippi, Giuseppe
2022

Abstract

Objective We assessed the clinical performance of novel Roche Elecsys SARS-CoV-2 Antigen fully automated electrochemiluminescence immunoassay (ECLIA). Design and methods We tested 160 subjects, 110 (68.8%) with positive molecular test for SARS-CoV-2 infection in nasopharyngeal samples with Altona Diagnostics RealStar SARS-CoV-2 RT-PCR Kit and Roche Elecsys SARS-CoV-2 Antigen. Results Highly significant correlation was found between Elecsys SARS-CoV-2 Antigen ECLIA and cycle threshold (Ct) values of SARS-CoV-2 S and E genes (both r = −0.91; p < 0.001). The area under the curve (AUC), sensitivity and specificity of Elecsys SARS-CoV-2 Antigen ECLIA were 0.83, 0.43 and 1.00 in all samples, 0.99, 0.87 and 0.99 in those with both Ct values < 30, as well as 1.00, 1.00 and 0.89 in samples with both Ct values < 25. Conclusion Roche Elecsys SARS-CoV-2 Antigen ECLIA may be a surrogate of molecular testing for identification of super-spreaders.
Performance, SARS-CoV-2, antigen, immunoassay
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/11562/1055575
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