Application of an improved method for the recombinant K39 enzyme-linked immunosorbent assay to detect visceral leishmaniasis disease and infection in Bangladesh

K. M. Kurkjian, Louise Vaz, R. Haque, C. Cetre-Sossah, S. Akhter, S. Roy, F. Steurer, J. Amann, M. Ali, R. Chowdhury, Y. Wagatsuma, J. Williamson, S. Crawford, R. F. Breiman, J. H. Maguire, C. Bern, W. E. Secor

Research output: Contribution to journalArticle

13 Citations (Scopus)

Abstract

Several serology-based immunoassays are used to diagnose visceral leishmaniasis (VL), a chronic protozoan parasitic disease caused by the Leishmania donovani complex. These tests are primarily designed to diagnose the most severe clinical form of VL, known as kala-azar. However, leishmanial infection is frequently asymptomatic and may manifest only as a positive serologic response or positive leishmanin skin test. We modified a previously described enzyme-linked immunosorbent assay (ELISA) that detects patient antibodies reactive with the recombinant Leishmania protein K39 (rK39) to confirm suspected kala-azar and to detect asymptomatic infection in a community study in Bangladesh. With the inclusion of a standard curve on each ELISA plate, the rK39 ELISA was more repeatable (kappa coefficient of agreement = 0.970) and more reliable compared to the original method (kappa = 0.587, P <0.001). The cutoff point for a positive antibody response was chosen based on the 99th percentile of the ELISA distribution for the negative-control sera. However, we found that sera from all patients with active kala-azar yielded values more than twice the magnitude of this cutoff. Using receiver-operator characteristic curves, we determined a second cutoff value predictive of kala-azar. Using these criteria, the sensitivity and specificity of the modified ELISA for kala-azar were 97.0% and 98.9%, respectively, for sera from our study population. We hypothesize that individuals with antibody levels greater than the 99th percentile of the negative controls but less than the cutoff point for kala-azar have asymptomatic leishmanial infections.

Original languageEnglish (US)
Pages (from-to)1410-1415
Number of pages6
JournalClinical and Diagnostic Laboratory Immunology
Volume12
Issue number12
DOIs
StatePublished - Dec 2005
Externally publishedYes

Fingerprint

Immunosorbents
Visceral Leishmaniasis
Bangladesh
Assays
Enzyme-Linked Immunosorbent Assay
Enzymes
Infection
Antibodies
Asymptomatic Infections
Recombinant proteins
Serum
Skin
Leishmania donovani
Parasitic Diseases
Leishmania
Serology
Skin Tests
Immunoassay
Recombinant Proteins
Antibody Formation

ASJC Scopus subject areas

  • Microbiology (medical)
  • Immunology and Allergy
  • Clinical Biochemistry
  • Immunology

Cite this

Application of an improved method for the recombinant K39 enzyme-linked immunosorbent assay to detect visceral leishmaniasis disease and infection in Bangladesh. / Kurkjian, K. M.; Vaz, Louise; Haque, R.; Cetre-Sossah, C.; Akhter, S.; Roy, S.; Steurer, F.; Amann, J.; Ali, M.; Chowdhury, R.; Wagatsuma, Y.; Williamson, J.; Crawford, S.; Breiman, R. F.; Maguire, J. H.; Bern, C.; Secor, W. E.

In: Clinical and Diagnostic Laboratory Immunology, Vol. 12, No. 12, 12.2005, p. 1410-1415.

Research output: Contribution to journalArticle

Kurkjian, KM, Vaz, L, Haque, R, Cetre-Sossah, C, Akhter, S, Roy, S, Steurer, F, Amann, J, Ali, M, Chowdhury, R, Wagatsuma, Y, Williamson, J, Crawford, S, Breiman, RF, Maguire, JH, Bern, C & Secor, WE 2005, 'Application of an improved method for the recombinant K39 enzyme-linked immunosorbent assay to detect visceral leishmaniasis disease and infection in Bangladesh', Clinical and Diagnostic Laboratory Immunology, vol. 12, no. 12, pp. 1410-1415. https://doi.org/10.1128/CDLI.12.12.1410-1415.2005
Kurkjian, K. M. ; Vaz, Louise ; Haque, R. ; Cetre-Sossah, C. ; Akhter, S. ; Roy, S. ; Steurer, F. ; Amann, J. ; Ali, M. ; Chowdhury, R. ; Wagatsuma, Y. ; Williamson, J. ; Crawford, S. ; Breiman, R. F. ; Maguire, J. H. ; Bern, C. ; Secor, W. E. / Application of an improved method for the recombinant K39 enzyme-linked immunosorbent assay to detect visceral leishmaniasis disease and infection in Bangladesh. In: Clinical and Diagnostic Laboratory Immunology. 2005 ; Vol. 12, No. 12. pp. 1410-1415.
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AU - Roy, S.

AU - Steurer, F.

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AU - Ali, M.

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AU - Wagatsuma, Y.

AU - Williamson, J.

AU - Crawford, S.

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