Diagnostic performance of the fully automated Roche Elecsys SARS-CoV-2 antigen electrochemiluminescence immunoassay: a pooled analysis

Abstract

Abstract Objectives Among the diagnostic tests that have recently become commercially available for diagnosing coronavirus disease 2019 (COVID-19), the fully-automated Roche Elecsys severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antigen electrochemiluminescence immunoassay (ECLIA) is one of the most widespread for its adaptability within a system of laboratory automation, rapidity and high-throughput. This article is aimed to provide the results of the first pooled analysis of its accuracy for diagnosing SARS-CoV-2 infections. Content We carried out an electronic search in Scopus and Medline, without language or date restrictions (i.e., up to January 18, 2022), to identify articles where the diagnostic performance of Roche Elecsys SARS-CoV-2 antigen ECLIA was compared with that of reference molecular diagnostic techniques. Summary Overall, 11 studies were identified, 10 of which (n=6,095 swabs) provided necessary data for inclusion in a pooled analysis. The pooled diagnostic sensitivity, specificity and area under the curve (AUC) in nasopharyngeal samples were 0.68 (95%CI, 0.66–0.70), 0.99 (95%CI, 0.99–0.99) and 0.958 (95%CI, 0.936–0.980), respectively. The cumulative observed agreement with reference molecular assays was 89.5% and the kappa statistic was 0.735 (95%CI, 0.716–0.754). The pooled diagnostic sensitivity in samples with high viral load (i.e., cycle threshold values <28–30) was 0.95 (95%CI, 0.92–0.97). Outlook The results of this pooled analysis confirm that the fully-automated Roche Elecsys SARS-CoV-2 antigen ECLIA has high diagnostic specificity and optimal diagnostic sensitivity for identifying nasopharyngeal samples with higher viral load, thus making it a reliable technique for mass screening and for supporting strategies based on shorten isolation and/or quarantine.