Comparison of six COVID-19 serology assays for detection of antibodies from patients infected with ancestral and a spectrum of SARS-CoV-2 variants.

Access microbiology Pub Date : 2025-07-07 eCollection Date: 2025-01-01 DOI:10.1099/acmi.0.000974.v3
Rachel Lau, Chandrika Senthilkumaran, Jeffrey Chong, Freda Qi, Rosmol-Stanes Pulikkottil, Jennifer Ma, Katherene Ogbulafor, Larry Gabe, Kathy Manguiat, Alyssia Robinson, Heidi Wood, Angel Xinliu Li, Mohammad Mozafarihashjin, Aaron Campigotto, Allison J McGeer, Samira Mubareka, Jonathan B Gubbay, Julianne V Kus, Shelly Bolotin, Melissa Richard-Greenblatt, Vanessa Tran
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Abstract

Serology assays against spike, receptor binding domain (RBD) and nucleocapsid proteins of the severe acute respiratory syndrome coronavirus 2 are essential for serosurveillance. We performed a comparison of four medium-to-high throughput commercial assays [Abbott Laboratories, Ortho Clinical Diagnostics, Meso Scale Diagnostics (MSD)], one point-of-care test (ZEKMED) and a laboratory-developed plaque reduction neutralization test using a reference panel and clinical specimens. Overall, the assays showed a high positive percent agreement of ≥85% and negative percent agreement of ≥90%, with the MSD anti-spike IgG assay having the best performance (100% in both). Notably, Abbott anti-nucleocapsid IgG, MSD anti-spike IgG and ZEKMED anti-spike RBD IgM/IgG combined assays were able to detect antibodies from individuals infected with all different variants tested - Alpha, Beta, Gamma, Delta and Omicron. The limit of detection (LOD) of the assays ranged from 9.9 to 62.0 BAU ml-1, with the Abbott anti-spike RBD having the lowest LOD. The COVID-19 serology assays will continue to be useful in determining seroprevalence from infection and vaccination.

6种COVID-19血清学检测方法检测祖先型和SARS-CoV-2变异谱患者抗体的比较
严重急性呼吸综合征冠状病毒2型刺突、受体结合结构域(RBD)和核衣壳蛋白的血清学检测对血清监测至关重要。我们对四种中高通量商业检测方法(雅培实验室、Ortho临床诊断、Meso Scale Diagnostics (MSD))、一种即时检测方法(ZEKMED)和一种使用参考面板和临床标本的实验室开发的斑块减少中和试验进行了比较。总体而言,两种检测方法的阳性符合率≥85%,阴性符合率≥90%,其中MSD抗尖峰IgG检测方法的表现最好(两者均为100%)。值得注意的是,雅培抗核衣壳IgG、MSD抗刺突IgG和ZEKMED抗刺突RBD IgM/IgG联合检测能够检测到所有不同变体(α、β、γ、δ和Omicron)感染个体的抗体。检测限(LOD)范围为9.9 ~ 62.0 BAU ml-1,其中Abbott抗尖峰RBD的LOD最低。COVID-19血清学检测将继续有助于确定感染和疫苗接种的血清流行率。
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