Sensitivity and specificity of the Leishmania OligoC-TesT and NASBA-oligochromatography for diagnosis of visceral leishmaniasis in Kenya

Trop Med Int Health. 2010 Jul;15(7):806-10. doi: 10.1111/j.1365-3156.2010.02548.x. Epub 2010 May 14.

Abstract

Objective: To estimate the sensitivity and specificity of the OligoC-TesT and nucleic acid sequence-based amplification coupled to oligochromatography (NASBA-OC) for molecular detection of Leishmania in blood from patients with confirmed visceral leishmaniasis (VL) and healthy endemic controls from Kenya.

Methods: Blood specimens of 84 patients with confirmed VL and 98 endemic healthy controls from Baringo district in Kenya were submitted to both assays.

Results: The Leishmania OligoC-TesT showed a sensitivity of 96.4% (95% confidence interval [CI]: 90-98.8%) and a specificity of 88.8% (95% CI: 81-93.6%), while the sensitivity and specificity of the NASBA-OC were 79.8% (95% CI: 67-87%) and 100% (95% CI: 96.3-100%), respectively.

Conclusion: Our findings indicate high sensitivity of the Leishmania OligoC-TesT on blood while the NASBA-OC is a better marker for active disease.

Publication types

  • Clinical Trial, Phase II
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Animals
  • DNA, Protozoan / blood
  • Endemic Diseases
  • Humans
  • Kenya / epidemiology
  • Leishmania donovani / genetics
  • Leishmania donovani / isolation & purification*
  • Leishmaniasis, Visceral / diagnosis*
  • Leishmaniasis, Visceral / epidemiology
  • Polymerase Chain Reaction / methods*
  • RNA, Protozoan / blood
  • Reproducibility of Results
  • Self-Sustained Sequence Replication / methods*
  • Sensitivity and Specificity

Substances

  • DNA, Protozoan
  • RNA, Protozoan