Poor performance of two rapid immunochromatographic assays for anti-Japanese encephalitis virus immunoglobulin M detection in cerebrospinal fluid and serum from patients with suspected Japanese encephalitis virus infection in Laos.

Onanong Sengvilaipaseuth,Anisone Chanthongthip,Paul N Newton,Manivanh Vongsouvath,Soulignasack Thongpaseuth,Audrey Dubot-Pérès,Tehmina Bharucha,Josée Castonguay-Vanier,Ooyanong Phonemixay

doi:10.1093/trstmh/trx067

Abstract

Background Japanese encephalitis virus (JEV) is a leading identified cause of encephalitis in Asia, often occurring in rural areas with poor access to laboratory diagnostics. We evaluated two rapid diagnostic tests (RDTs) for anti-JEV immunoglobulin M (IgM) detection.MethodsConsecutive cerebrospinal fluid and serum from 388 patients (704 samples) with suspected JEV infections admitted to six hospitals in Laos were tested with one of two SD-Bioline anti-JEV IgM RDTs and the World Health Organization standard anti-JEV IgM enzyme-linked immunosorbent assay (ELISA; Panbio Japanese Encephalitis–Dengue IgM Combo ELISA.Results and ConclusionsThe performance of both RDTs showed strikingly low sensitivity in comparison to anti-JEV IgM antibody capture ELISA (2.1–51.4%), suggesting low sensitivity of the RDTs. We highlight the fundamental prerequisite to validate RDTs prior to use to ensure that they meet standards for testing.

Highlights

Japanese encephalitis virus (JEV) is a leading cause of encephalitis in Asia, with an estimated 69 000 cases per year, 30–50% associated neurological sequelae and 30% mortality.[1]
enzyme-linked immunosorbent assays (ELISAs) and rapid diagnostic tests (RDTs) results were analysed in a 2×2 table, with sensitivity and specificity (95% confidence intervals [CIs]) calculated using STATA 13.1 (StataCorp, College Station, TX, USA).[15]
The study was performed in two phases: (1) SD-Bioline JEV IgG/immunoglobulin M (IgM) RDT tested on 200 patients with assays read by four independent investigators and (2) SD-Bioline JEV IgM RDT tested on 188 patients with assays read by two independent investigators. cJEV-Dengue IgM Combo ELISA kit (Panbio ELISA), Inverness Medical Innovations, Brisbane, Australia

Summary

Background

Japanese encephalitis virus (JEV) is a leading identified cause of encephalitis in Asia, often occurring in rural areas with poor access to laboratory diagnostics. We evaluated two rapid diagnostic tests (RDTs) for anti-JEV immunoglobulin M (IgM) detection

Methods

Results and Conclusions

Introduction

Ethical statement

Results and discussion