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

Pract Lab Med. 2022 Mar:29:e00265. doi: 10.1016/j.plabm.2022.e00265. Epub 2022 Jan 15.

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.

Keywords: COVID-19; Diagnosis; Immunoassay; Laboratory medicine; SARS-CoV-2.