Measuring the sero-prevalence of Leishmania donovani induced cutaneous leishmaniasis: A method comparison study |
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| Affiliation: | 1. Department of Parasitology, Faculty of Medicine, University of Colombo, Colombo 00800, Sri Lanka;2. CSIR-Indian Institute of Chemical Biology, Kolkata, West Bengal 700032, India;3. Department of Biochemistry and Molecular Biology, Faculty of Medicine, University of Colombo, Colombo 00800, Sri Lanka;1. Phytochemistry, Analytical Chemistry Laboratory, CSIR-Central Institute of Medicinal and Aromatic Plants, Lucknow 226015, India;2. Molecular Bioprospection Department, CSIR-Central Institute of Medicinal and Aromatic Plants, Lucknow 226015, India;3. Department of Metabolic and Structural Biology, CSIR-Central Institute of Medicinal and Aromatic Plants, Lucknow 226015, India;2. Hebei Collaborative Innovation Center for Eco-Environment, Hebei Province, PR China;3. Key Laboratory of Molecular Cell Biology, Ministry of Education of the People''s Republic of China, People''s Republic of China;1. Department of Microbiology, University of Medicine 1, No. 245, Myoma Kyaung Street, Lanmadaw Township, Yangon, Myanmar;2. Division of Parasitology, Department of Infectious Diseases, Faculty of Medicine, University of Miyazaki, 5200 Kihara, Kiyotake, Miyazaki 889-1692, Japan;3. Department of Parasitology, Faculty of Veterinary Medicine, Vietnam National University of Agriculture, Hanoi 12406, Viet Nam;4. Hirakawa Zoological Park, 5669-1 Hirakawa-cho, Kagoshima-shi, Japan;5. Koshima Field Station, Wildlife Research Center, Kyoto University, 16-1 Ichiki, Kushima, Miyazaki 889-3311, Japan;6. Yokohama Zoological Gardens Zoorasia, 1171-1, Kami-Shirane-cho, Yokohama 241-0001, Japan;7. Laboratory of Veterinary Parasitic Diseases, Department of Veterinary Sciences, Faculty of Agriculture, University of Miyazaki, 1-1 Gakuen-kibanadai-nishi, 889-2192 Miyazaki, Japan;8. Center for Animal Disease Control, University of Miyazaki, 1-1 Gakuen-kibanadai-nishi, 889-2192 Miyazaki, Japan;1. Department of Parasitology, Faculty of Veterinary Medicine, Cairo University, Egypt;2. Department of Pathology, Faculty of Veterinary Medicine, Cairo University, Egypt;1. Laboratory of Vaccinology and Applied Immunology, Kanazawa University School of Pharmacy, Kanazawa, Ishikawa 920-1192, Japan;2. Department of Global Infectious Diseases, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, Ishikawa 920-0934, Japan;3. Division of Gene Therapy, Jichi Medical University, Shimotsuke, Tochigi 329-0498, Japan;4. Department of Parasitology, Faculty of Medicine, Hasanuddin University, Makassar, Sulawesi Selatan 90245, Indonesia;5. Institute for Genetic Medicine, Hokkaido University, Sapporo, Hokkaido 060-0815, Japan;1. Institute of Medical Research and Medicinal Plants studies, PO Box 13033, Yaoundé, Cameroon;2. Department of Biochemistry, Faculty of Science, University of Douala, PO Box 24157, Douala, Cameroon;3. ICMR-National Institute of Malaria Research, Dwarka, Sector 8, New Delhi 110077, India |
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| Abstract: | An in-house enzyme-linked immunosorbent assay (ELISA) based on crude antigen of Leishmania reported a high sero-prevalence (82.0%) in Leishmania donovani induced cutaneous leishmaniasis (CL) in Sri Lanka. ELISA was further compared with established serological tools to identify a suitable point of care diagnostic tool. Sero-prevalence of 100 CL samples were analyzed using in-house ELISA, Indian dipstick test and rK39 strip test. Results obtained were further compared with direct agglutination test (DAT) for 40 CL. Test performance was evaluated using Kappa index value. Clinico-epidemiological characteristics of patients were analyzed using SPSSv25.0. Cost analysis of tests was carried out. ELISA showed a high sero-positivity of 81.0% (n = 81/100) while DAT (57.5%,n = 23/40), Indian dipstick test (22.0%,n = 22/100) and rK39 test (15.0%,n = 15/100) showed a comparatively less sero-positivity. According to Kappa index values, there were no perfect agreement between tests. Among ELISA positive patients (n = 81/100), DAT, Indian dipstick test and rK39 demonstrated sero-positivity rates of 61.3% (n = 19/31), 25.9% (n = 21/81) and 16.0% (n = 13/81) respectively. Among ELISA negative patients (n = 19/100), three assays demonstrated sero-positivity rates of 44.4% (n = 4/9), 5.3% (n = 1/9) and 10.5% (n = 2/19) respectively. DAT can be used as an alternative test when ELISA is not available or negative. Clinico-epidemiological profiles of patients that showed sero-positivity by each assay were different. Cost per patient was approximately 5.5 USD for DAT and 3.0 USD for each other tests. Established serological tests demonstrated different and relatively lower detection rates. Species, strain and antigen heterogeneity, inconsistency in amount of used antigens, sera, antibody expression patterns and testing methodologies could be responsible. This study highlighted the importance of designing an in-house serological assay based on local parasite. |
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