Comparative evaluation of select serological assays for Zika virus using blinded reference panels

The aim of this study was to compare assays for detection of immunoglobulin M and/or G (IgM or IgG) from multiple manufacturers. Panels of specimens for testing IgM and IgG assays were built using longitudinal samples collected from blood donors with viral RNA confirmed infections with ZIKV, dengue virus (DENV) and West Nile virus (WNV), respectively. Specimens IgM- or IgG-positive against chikungunya virus (CHIKV), of the genus alphavirus were also included, together with ZIKV-negative samples from endemic (Puerto Rico) and non-endemic (continental USA) regions. Panels were compiled, blinded, and sent to manufacturers for testing. Seven IgM and five IgG assays from four manufacturers were evaluated.

本研究旨在对比多家厂商生产的免疫球蛋白M（immunoglobulin M, IgM）和/或免疫球蛋白G（immunoglobulin G, IgG）检测试剂。研究人员采集经病毒RNA确认感染寨卡病毒（ZIKV）、登革病毒（DENV）与西尼罗河病毒（WNV）的献血者的纵向样本，以此构建用于IgM和IgG检测的标本组。本研究同时纳入了针对甲病毒属基孔肯雅病毒（CHIKV）呈IgM或IgG阳性的标本，以及来自流行区（波多黎各）与非流行区（美国大陆）的寨卡病毒阴性样本。上述标本组经组建、盲法处理后被送往各参与厂商开展检测，最终评估了来自4家厂商的7种IgM检测试剂与5种IgG检测试剂。