Evaluating the Performance of Four SARS-CoV-2 Commercial Chemiluminescence Immunoassays

Abstract

Background: COVID-19 is a pandemic of serious global threat that forced test developers to flood the market with various diagnostic assays that have been independently validated. Objectives: This study aims at assessing the performance of four SARS-CoV-2 chemiluminescence immunoassays. Methodology: The present study included sera from 96 Polymerase Chain Reaction (PCR)–confirmed COVID-19 cases collected at 2 time periods (5-9 days and 9-14 days post symptom onset) during patient follow-up, and 30 control sera from COVID-19 PCR–negative individuals. All sera were tested for SARS-CoV-2 antibodies using four high-throughput commercially available chemiluminescence immunoassays: YHLO Biotech Co, Ltd China (IgM and IgG); Abbott, Abbott USA (IgG); Roche, Roche US (total: IgM, IgG, and IgA), and Ortho, Ortho Clinical Diagnostics, USA (total and individual IgG). Results: For the detection of total antibodies (IgM, IgG, and IgA), the highest sensitivities were for Ortho followed by Roche assays (91.6% and 84.3% in 5-9 days period, respectively) raised to 96.8% and 92.7% in 9-14 days respectively with significant difference P-value <0.00001. Ortho, Roche, and YHLO iFlash (IgM) assays had specificities of 100%, 100%, and 90.3% respectively. Roche (Total) and Ortho (Total) assays showed perfect categorical agreement (94.4% in 5-9 days, and 96.4% in 9-14 days). As for the detection of individual IgG antibodies, the Abbott assay had the highest sensitivity (91.6% in 5-9 days, and 93.7% in 9-14 days), followed by Ortho and YHLO iFlash assays (84.3%, and 83.3% in 5-9 days respectively) that increased to 89.5% and 88.5% in 9-14 days respectively. Ortho assay was the best in specificity (100%), followed by Abbott (98.8%) and YHLO iFlash (96.3%). YHLO iflash (IgG) and Ortho (IgG) showed perfect agreement (96.8%) in the 2 time frames. Conclusion: Ortho assay showed the best performance in detecting total antibodies with perfect match to Roche assay, while Abott assay was the best performing in detecting individual IgG with perfect match to Ortho assay rendering them to be efficient diagnostic tools