Abstract:
Background: Visceral leishmaniasis in Ethiopia is a re-emerging threat to public health, with increased geographical
distribution and number of cases. It is a fatal disease without early diagnosis and treatment; thus, the availability of
affordable diagnostic tools is crucial. However, due to delays caused by import regulations, procurement and late
delivery of imported test kits, accessibility remains a problem in the control program. Therefore, we aimed to
produce and evaluate the performance of an in-house liquid (AQ) direct agglutination test (DAT) antigen.
Result: The AQ-DAT was produced at the Armauer Hansen Research Institute, using Leishmania donovani strain
(MHOM/ET/67/L82). Sera from 272 participants; 110 microscopically confirmed cases of VL, 76 apparently healthy
and 86 patients who had infectious disease other than VL were tested with AQ-DAT, and standard kits: Freeze-dried
DAT (FD-DAT) and rK39. Taking microscopy as a gold standard; the sensitivity and specificity of the AQ-DAT were
97.3 and 98.8%, respectively. It had high degrees of agreement (k > 0.8), with a significant (P < 0.05) correlation
compared to microscopy, FD-DAT, and rK39.
Conclusion: Although further standardization is required, the in-house AQ-DAT could improve diagnostic
accessibility, minimize intermittent stock outs and strengthen the national VL control program.
Keywords: Liquid direct agglutination test, Visceral leishmaniasis, North West Ethiopia
