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Validation of a β-ME ELISA for Detection of Anti Leishmania donovani Antibodies in Eastern Sudan | ||
Iranian Journal of Immunology | ||
مقاله 2، دوره 8، شماره 3، آذر 2011، صفحه 150-158 اصل مقاله (280.28 K) | ||
نوع مقاله: Original Article | ||
نویسندگان | ||
Elfadil Abass1؛ Abdelhafeiz Mahamoud1؛ Durria Mansur1؛ Mehdi Mohebali2؛ Abdollah el Harith* 3 | ||
1Biomedical Research Laboratory, Ahfad University for Women, Omdurman, Sudan | ||
2Department of Medical Parasitology and Mycology, School of Public Health, University of Medical Sciences, Tehran, Iran | ||
3Professor emeritus of Microbiology, Ahfad University for Women, Omdurman, Sudan | ||
چکیده | ||
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<0.01, 0.919) was established between β-ME ELISA and FD-DAT than between β-ME ELISA and RKT (p<0.01, 0.824). Taking into calculation the combined estimates of sensitivity, specificity, positive and negative predictive values, higher agreement (94.8%) was determined between total performance of β-ME ELISA and FD-DAT than between that of β-ME ELISA and RKT (90.7%). Conclusion: Based on results and merits discussed, we recommend application of this β-ME ELISA both for diagnosis of VL at laboratory level and confirmation of results obtained with DAT or RKT in the field. | ||
کلیدواژهها | ||
β-ME؛ DAT؛ ELISA؛ rK39 Antigen؛ visceral leishmaniasis | ||
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