Comparison of six commercial tick-borne encephalitis IgM and IgG ELISA kits and the molecular characterization of their antigenic design

Diagn Microbiol Infect Dis. 2018 Apr;90(4):286-292. doi: 10.1016/j.diagmicrobio.2017.12.012. Epub 2017 Dec 22.

Abstract

Tick-borne encephalitis virus (TBEV) diagnosis is mainly based on the detection of viral-specific antibodies in serum. Several commercial assays are available, but published data on their performance remain unclear. We assessed six IgM and six IgG commercial enzyme-linked immunosorbent assay (ELISA) kits (ELISA-1 through ELISA-6) using 94 samples, including precharacterized TBEV-positive samples (n=50) and -negative samples (n=44). The six manufacturers showed satisfactory sensitivity and specificity and high overall agreement for both IgM and IgG. Three manufacturers showed better reproducibility and were the most sensitive (100%) and specific (95.5-98.1%) for both IgM and IgG. Two of them were also in agreement with the clinical interpretation in more than 90% of the cases. All the assays use inactivated virus as antigen, with strains showing approximately 94% homology at the amino acid level. The antigenic format of the assays was discussed to further improve this TBEV diagnostic tool.

Keywords: ELISA; Flaviviruses; Laboratory diagnosis; Tick-borne encephalitis virus.

Publication types

  • Comparative Study
  • Evaluation Study

MeSH terms

  • Antibodies, Viral / blood*
  • Encephalitis, Tick-Borne / diagnosis*
  • Enzyme-Linked Immunosorbent Assay / methods*
  • Humans
  • Immunoglobulin G / blood*
  • Immunoglobulin M / blood*
  • Reagent Kits, Diagnostic
  • Reproducibility of Results
  • Sensitivity and Specificity
  • Serologic Tests / methods*

Substances

  • Antibodies, Viral
  • Immunoglobulin G
  • Immunoglobulin M
  • Reagent Kits, Diagnostic