Evaluation of the genalyte maverick SARS-CoV-2 multi-antigen serology panel

Abstract

Serologic testing for SARS-CoV-2 can be used for evaluation of past infection in individual patients and for community seroprevalence studies. We evaluated the analytical and clinical performance of the Genalyte Maverick SARS-CoV-2 Multi-Antigen Serology Panel compared to the Roche Elecsys Anti-SARS-CoV-2 nucleocapsid (NC) qualitative immunoassay, using well characterized clinical serum samples. A total of 143 pre-pandemic sera and 48 sera collected from patients with a negative molecular SARS-CoV-2 result were used for specificity studies. For sensitivity analyses, 179 sera were used, obtained 3-7 days, 8-14 days, or ≥ 15 days after symptom onset from patients with confirmed SARS-CoV-2 infection. Specificity was determined to be 95.3% (182/191) for the Genalyte Maverick. Overall sensitivity of the Genalyte Maverick was similar to that observed for the Roche Elecsys NC test, 79.3% (142/179) vs. 76.5% (137/179), respectively. Genalyte Maverick trended, without statistical significance, towards higher sensitivity as compared to the Roche Elecsys NC test in the 3-7 days (11/25 vs. 9/25, respectively) and 8-14 days (21/28 vs. 19/28, respectively) post-symptom onset sample sets, but was identical in the ≥ 15 days post-symptom onset group (106/116 vs. 106/116, respectively). Therefore, the Genalyte Maverick serologic test had similar overall sensitivity to the Roche Elecsys NC assay, but may have slightly improved sensitivity for early seroconversion. The lower Genalyte Maverick specificity as compared to the Roche Elecsys NC assay as reported by other studies (>99%), may necessitate confirmatory testing of positive Genalyte Maverick results if implemented for clinical use.

Keywords

• Coronavirus
• SARS-CoV-2
• COVID-19
• Serology