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

Trans R Soc Trop Med Hyg. 2017 Aug 1;111(8):373-377. 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.

Methods: Consecutive 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 conclusions: The 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.

Keywords: Central nervous system infection; Immunoassays; Japanese encephalitis virus; Laos, Rapid diagnostic tests; South-East Asia.

MeSH terms

  • Adolescent
  • Adult
  • Antibodies, Viral / metabolism*
  • Cerebrospinal Fluid / chemistry*
  • Child
  • Child, Preschool
  • Chromatography, Affinity*
  • Encephalitis Virus, Japanese / immunology*
  • Encephalitis, Japanese / diagnosis*
  • Encephalitis, Japanese / epidemiology
  • Female
  • Humans
  • Immunoglobulin M / metabolism*
  • Laos / epidemiology
  • Male
  • Reproducibility of Results
  • Young Adult

Substances

  • Antibodies, Viral
  • Immunoglobulin M