Validation of in-house liquid direct agglutination test antigen: the potential diagnostic test in visceral Leishimaniasis endemic areas of Northwest Ethiopia

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 i...

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Published in:	BMC microbiology Vol. 20; no. 1; p. 90
Main Authors:	Ayelign, Birhanu, Jemal, Mohammedamin, Negash, Markos, Genetu, Meaza, Wondmagegn, Tadelo, Zeleke, Ayalew Jejaw, Worku, Ligabaw, Bayih, Abebe Genetu, Shumie, Girma, Behaksra, Sinknesh Wolde, Fenta, Tiruwork, Damte, Demekech, Yeshanew, Arega, Gadisa, Endalamaw
Format:	Journal Article
Language:	English
Published:	England BioMed Central Ltd 15-04-2020 BioMed Central BMC
Subjects:	Accessibility Agglutination Antigens Care and treatment Diagnosis Diagnostic software Diagnostic systems Diagnostic tests Gene expression Geographical distribution Health aspects Health care Import regulations Infectious diseases International economic relations International trade Leishmaniasis Liquid direct agglutination test Manual workers Meglumine antimoniate Microscopy Miltefosine North West Ethiopia Parasitic diseases Paromomycin Procurement Public health Scientific equipment industry Standardization Studies Tropical diseases Vector-borne diseases Visceral leishmaniasis Belgium United States Ethiopia Sudan Brazil United Kingdom > UK East Africa North West Ethiopia Visceral leishmaniasis Liquid direct agglutination test
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Summary:	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. 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. 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.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	1471-2180 1471-2180
DOI:	10.1186/s12866-020-01780-0