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

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Author(s): Elfadil Abass | Abdelhafeiz Mahamoud | Durria Mansour | Mehdi Mohebali | Abdallah el Harith

Journal: Iranian Journal of Immunology
ISSN 1735-1383

Volume: 8;
Issue: 3;
Start page: 150;
Date: 2011;
Original page

Keywords: β-ME | DAT | ELISA | rK39 Antigen | Visceral Leishmaniasis

ABSTRACT
Background: A β-mercaptoethnol (β-ME)-treated promastigote antigen of L. donovaniwas successfully employed in direct agglutination test (DAT) for the diagnosis ofvisceral leishmaniasis (VL). Objective: The β-ME-treated antigen was furtherincorporated into an enzyme-linked immunosorbent assay set-up (β-ME ELISA) andevaluated 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 serafrom patients with high VL suspicion of whom 105 had confirmed L. donovaniinfection 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-DATas compared to 83.8% (95% CI: 76.7-90.8) for RKT. Of 73 VL sera that scoredmaximum absorbance values (>0.81) in β-ME ELISA, 66 (90.4%) tested at the highestagglutination titres (>1:51200) in FD-DAT as did 56 (76.7%) also at comparablereaction 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 wasestimated for β-ME ELISA (90.4%, 95% CI: 86.1-94.6). Based both on positive andnegative microscopy for L. donovani in organ aspirates of all VL suspects enrolled(292), significantly higher correlation (p
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