A surrogate assay for measuring Coxsackievirus A6 neutralizing antibodies

Hum Vaccin Immunother. 2018;14(12):3034-3040. doi: 10.1080/21645515.2018.1504540. Epub 2018 Aug 17.

Abstract

Coxsackievirus A6 (CV-A6) is one of pathogens causing hand, foot and mouth disease (HFMD) and becomes a new challenge to HFMD control. In this study, we first built a single-round pseudovirus infection system for CV-A6, and then developed a pseudovirus luciferase assay (PVLA) for anti-CV-A6 neutralizing antibody (NtAb) quantification. Since cytopahtic effect (CPE) is considered as the gold standard test for anti-enterovirus NtAb detection, a comparison study has been performed using 318 clinical serum samples, as measured both by PVLA and CPE. The sensitivity and specificity of PVLA was 94.9% (95% CI between 90.8-97.5%) and 92.7% (95% CI between 86.6-96.6%), respectively. Statistical analysis revealed that PVLA and CPE were highly correlated (spearman r = 0.931, P < 0.0001) and in good agreement (94.0%, 95% CI between 90.8-96.4%), showing that PVLA could be used as a surrogate assay for anti-CV-A6 NtAb detection and served as a valuable tool for CV-A6 vaccine evaluation and CV-A6 epidemiological surveillance.

Keywords: Coxsackievirus A6; neutralizing antibody; pseudovirus; pseudovirus luciferase assay.

Grants and funding

The current study was sponsored by the Major Special Projects Funding Program (No. 2016ZX09101120) from the Ministry of Science and Technology of the People’s Republic of China. The funders had no role in study design, data collection and analysis, data interpretation, decision to publish, or preparation of the manuscript.