Evaluation of an in-house ELISA using the intermediate species Leptospira fainei for diagnosis of leptospirosis

J Med Microbiol. 2013 Jun;62(Pt 6):822-827. doi: 10.1099/jmm.0.054304-0. Epub 2013 Mar 14.

Abstract

Leptospirosis is recognized as an emerging zoonotic disease generally affecting urban slums in developing countries and tropical regions. A combination of non-specific symptoms, low awareness among the medical community and a lack of readily available diagnostic tests have made leptospirosis an underdiagnosed disease. In this study, we tested an in-house ELISA with formalin-treated and boiled bacteria from the intermediate species Leptospira fainei as an antigen to detect Leptospira-specific IgM antibodies. A total of 819 serum samples, tested by a microscopic agglutination test (MAT) as a reference test, were used to evaluate the ELISA. Compared with positive and negative sera, the ELISA showed 94 % sensitivity and 99 % specificity. Positive and negative likelihood ratios were 94 and 0.06, respectively. No cross-reactivity was observed in sera from subjects with dengue and syphilis infections. The kappa value was 0.92 (95 % confidence interval 0.88-0.96), which indicated excellent agreement between the MAT and ELISA. The overall performance of this in-house ELISA suggests applicability as a rapid screening test for the diagnosis of leptospirosis in resource-limited settings and in hospitals and laboratories where a MAT is not available.

Publication types

  • Evaluation Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Agglutination Tests
  • Antibodies, Bacterial / blood*
  • Child
  • Developing Countries
  • Enzyme-Linked Immunosorbent Assay / methods*
  • Female
  • Humans
  • Immunoglobulin M / blood
  • Leptospira / classification
  • Leptospira / immunology*
  • Leptospirosis / diagnosis*
  • Leptospirosis / immunology
  • Male
  • Middle Aged
  • Reagent Kits, Diagnostic
  • Sensitivity and Specificity
  • Young Adult

Substances

  • Antibodies, Bacterial
  • Immunoglobulin M
  • Reagent Kits, Diagnostic