Journal Article

Evaluation of eight commercial Zika virus IgM and IgG serology assays for diagnostics and research

Low, Swee Ling, Wong, Judith Chui Ching, Lam, Sally, Ng, Lee Ching, Tan, Li Kiang, Lai, Yee Ling, Leo, Yee Sin, Tan, Hwee Huang

2021

Overview

Several commercial Zika virus (ZIKV) serology assays have been developed since the recognition of ZIKV outbreaks as a Public Health Emergency of International Concern in 2016. However, test interpretation for ZIKV serology can be challenging due to antibody cross-reactivity with other flaviviruses like dengue virus (DENV). Therefore, we sought to evaluate the performance of eight commercially available ZIKV IgM and IgG assays across three testing platforms, namely, immunochromatographic tests (ICT), ELISAs and immunofluorescence tests (IIFT). The test panel comprised of 278 samples, including acute and convalescent sera or plasma from ZIKV-confirmed, DENV-confirmed, non-ZIKV and non-DENV patients, and residual sera from healthy blood donors. The ZIKV IgM and IgG serology assays yielded higher test sensitivities of 23.5% - 97.1% among ZIKV convalescent samples as compared to 5.6% - 27.8% among ZIKV acute samples; the test specificities were 63.3% - 100% among acute and convalescent DENV, non-DENV samples. Among the ELISAs and IIFTs, the Diapro ZIKV IgM ELISA demonstrated high test sensitivity (96%) and specificity (80%) when tested on early convalescent samples, while the Euroimmun ZIKV IgG ELISA yielded the highest test specificity of 97% - 100% on samples from non-ZIKV patients and healthy blood donors. For rapid ICTs, the LumiQuick IgM rapid ICT yielded low test sensitivity, suggesting its limited utility. We showed that commercial ZIKV IgM and IgG serology assays have differing test performances, with some having moderate to high test sensitivities and specificities when used in a dengue endemic setting, although there were limitations in IgG serology.

• Publisher: Public Library of Science,Public Library of Science (PLoS)
• Subject: Antibodies / Antibodies, Viral - blood / Antibodies, Viral - immunology / Assaying / Biology and life sciences / Birth defects / Blood / Blood & organ donations / Blood donors / Complications / Congenital defects / Cross Reactions / Cross-reactivity / Dengue / Dengue - blood / Dengue - diagnosis / Dengue - immunology / Dengue fever / Dengue Virus - immunology / Dengue Virus - isolation & purification / Editing / Environmental health / Enzyme-linked immunosorbent assay / Enzyme-Linked Immunosorbent Assay - methods / Epidemics / Evaluation / Fluorescent Antibody Technique - methods / Funding / Guillain-Barre syndrome / Health aspects / Health care / Health sciences / Humans / Immunoassay / Immunoassay - methods / Immunofluorescence / Immunoglobulin G / Immunoglobulin G - blood / Immunoglobulin G - immunology / Immunoglobulin M / Immunoglobulin M - blood / Immunoglobulin M - immunology / Infections / Infectious diseases / Laboratories / Medicine and Health Sciences / Microencephaly / Mosquitoes / Neonates / Neurological complications / Patients / Performance evaluation / Plasma / Public health / Research and Analysis Methods / Reviews / Sensitivity and Specificity / Serologic Tests / Serology / Urine / Vector-borne diseases / Viruses / Zika virus / Zika Virus - immunology / Zika Virus - isolation & purification / Zika Virus Infection - blood / Zika Virus Infection - diagnosis / Zika Virus Infection - immunology