Validation of a β-ME ELISA for Detection of Anti Leishmania donovani Antibodies in Eastern Sudan

Authors

  • Abdelhafeiz Mahamoud Biomedical Research Laboratory, Ahfad University for Women, Omdurman, Sudan
  • Abdollah el Harith Professor emeritus of Microbiology, Ahfad University for Women, Omdurman, Sudan
  • Durria Mansur Biomedical Research Laboratory, Ahfad University for Women, Omdurman, Sudan
  • Elfadil Abass Biomedical Research Laboratory, Ahfad University for Women, Omdurman, Sudan
  • Mehdi Mohebali Department of Medical Parasitology and Mycology, School of Public Health, University of Medical Sciences, Tehran, Iran
Abstract:

Background: A β-mercaptoethnol (β-ME)-treated promastigote antigen of L. donovani was successfully employed in direct agglutination test (DAT) for the diagnosis of visceral leishmaniasis (VL). Objective: The β-ME-treated antigen was further incorporated into an enzyme-linked immunosorbent assay set-up (β-ME ELISA) and evaluated for VL diagnosis against outcome of reference freeze-dried DAT (FD-DAT) and rK39 strip test (RKT) commercial kits. Methods: Two-hundred and ninety-two sera from patients with high VL suspicion of whom 105 had confirmed L. donovani infection were tested. Results: Relatively higher sensitivities of 93.3% (95% CI: 88.4- 98.2) and 92.4% (95% CI: 87.3-97.5) were determined for β-ME ELISA and FD-DAT as compared to 83.8% (95% CI: 76.7-90.8) for RKT. Of 73 VL sera that scored maximum absorbance values (>0.81) in β-ME ELISA, 66 (90.4%) tested at the highest agglutination titres (>1:51200) in FD-DAT as did 56 (76.7%) also at comparable reaction intensities (3 + colour intensity) in RKT. Compared with FD-DAT (94.7%, 95% CI: 91.5-97.9) or RKT (93.0%, 95% CI: 89.3-96.6), lower specificity was estimated for β-ME ELISA (90.4%, 95% CI: 86.1-94.6). Based both on positive and negative microscopy for L. donovani in organ aspirates of all VL suspects enrolled (292), significantly higher correlation (p

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Journal title

volume 8  issue 3

pages  150- 158

publication date 2011-09-01

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