Comparison of the Diagnostic Performances of Five Different Tests in Diagnosing Visceral Leishmaniasis in an Endemic Region of Ethiopia
The lack of accurate and feasible diagnostic tests poses a significant challenge to visceral leishmaniasis (VL) healthcare services in endemic areas. To date, various VL diagnostic tests have been or are being developed, and their diagnostic performances need to be assessed. In the present study, th...
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MDPI AG
2024-01-01
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| Series: | Diagnostics |
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| Online Access: | https://www.mdpi.com/2075-4418/14/2/163 |
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| author | Dawit Gebreegziabiher Hagos Yazezew Kebede Kiros Mahmud Abdulkader Henk D. F. H. Schallig Dawit Wolday |
| author_facet | Dawit Gebreegziabiher Hagos Yazezew Kebede Kiros Mahmud Abdulkader Henk D. F. H. Schallig Dawit Wolday |
| author_sort | Dawit Gebreegziabiher Hagos |
| collection | DOAJ |
| description | The lack of accurate and feasible diagnostic tests poses a significant challenge to visceral leishmaniasis (VL) healthcare services in endemic areas. To date, various VL diagnostic tests have been or are being developed, and their diagnostic performances need to be assessed. In the present study, the diagnostic performances of rk39 RDT, the direct agglutination test (DAT), microscopy, loop-mediated isothermal amplification (LAMP), and miniature direct-on-blood polymerase chain reaction–nucleic acid lateral flow immunoassay (mini-dbPCR-NALFIA) were assessed using quantitative polymerase chain reaction (qPCR) as the reference test in an endemic region of Ethiopia. In this study, 235 suspected VL cases and 104 non-endemic healthy controls (NEHCs) were recruited. Among the suspected VL cases, 144 (61.28%) tested positive with qPCR. The sensitivities for rk39 RDT, DAT, microscopy, LAMP assay, and mini-dbPCR-NALFIA were 88.11%, 96.50%, 76.58%, 94.33%, and 95.80%, respectively. The specificities were 83.33%, 97.96%, 100%, 97.38%, and 98.92% for rk39 RDT, DAT, microscopy, LAMP assay, and mini-dbPCR-NALFIA, respectively. In conclusion, rk39 RDT and microscopy exhibited lower sensitivities, while DAT demonstrated excellent performance. LAMP and mini-dbPCR-NALFIA showed excellent performances with feasibility for implementation in remote endemic areas, although the latter requires further evaluation in such regions. |
| first_indexed | 2024-03-08T11:00:29Z |
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| last_indexed | 2024-03-08T11:00:29Z |
| publishDate | 2024-01-01 |
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| series | Diagnostics |
| spelling | doaj.art-bf0dfb601fca4b7c8ca860fddf243b562024-01-26T16:01:24ZengMDPI AGDiagnostics2075-44182024-01-0114216310.3390/diagnostics14020163Comparison of the Diagnostic Performances of Five Different Tests in Diagnosing Visceral Leishmaniasis in an Endemic Region of EthiopiaDawit Gebreegziabiher Hagos0Yazezew Kebede Kiros1Mahmud Abdulkader2Henk D. F. H. Schallig3Dawit Wolday4Department of Medical Microbiology and Immunology, College of Health Sciences, School of Medicine, Mekelle University, Mekelle 1871, EthiopiaDepartment of Internal Medicine, College of Health Sciences, School of Medicine, Mekelle University, Mekelle 1871, EthiopiaDepartment of Medical Microbiology and Immunology, College of Health Sciences, School of Medicine, Mekelle University, Mekelle 1871, EthiopiaLaboratory for Experimental Parasitology, Department of Medical Microbiology and Infection Prevention, Amsterdam University Medical Center, Meibergdreef 9, 1105 AZ Amsterdam, The NetherlandsDepartment of Medical Microbiology and Immunology, College of Health Sciences, School of Medicine, Mekelle University, Mekelle 1871, EthiopiaThe lack of accurate and feasible diagnostic tests poses a significant challenge to visceral leishmaniasis (VL) healthcare services in endemic areas. To date, various VL diagnostic tests have been or are being developed, and their diagnostic performances need to be assessed. In the present study, the diagnostic performances of rk39 RDT, the direct agglutination test (DAT), microscopy, loop-mediated isothermal amplification (LAMP), and miniature direct-on-blood polymerase chain reaction–nucleic acid lateral flow immunoassay (mini-dbPCR-NALFIA) were assessed using quantitative polymerase chain reaction (qPCR) as the reference test in an endemic region of Ethiopia. In this study, 235 suspected VL cases and 104 non-endemic healthy controls (NEHCs) were recruited. Among the suspected VL cases, 144 (61.28%) tested positive with qPCR. The sensitivities for rk39 RDT, DAT, microscopy, LAMP assay, and mini-dbPCR-NALFIA were 88.11%, 96.50%, 76.58%, 94.33%, and 95.80%, respectively. The specificities were 83.33%, 97.96%, 100%, 97.38%, and 98.92% for rk39 RDT, DAT, microscopy, LAMP assay, and mini-dbPCR-NALFIA, respectively. In conclusion, rk39 RDT and microscopy exhibited lower sensitivities, while DAT demonstrated excellent performance. LAMP and mini-dbPCR-NALFIA showed excellent performances with feasibility for implementation in remote endemic areas, although the latter requires further evaluation in such regions.https://www.mdpi.com/2075-4418/14/2/163rk39 rapid diagnostic testdirect agglutination testmicroscopyloop-mediated isothermal amplificationminiature direct-on-blood polymerase chain reaction–nucleic acid lateral flow immunoassaydiagnostics |
| spellingShingle | Dawit Gebreegziabiher Hagos Yazezew Kebede Kiros Mahmud Abdulkader Henk D. F. H. Schallig Dawit Wolday Comparison of the Diagnostic Performances of Five Different Tests in Diagnosing Visceral Leishmaniasis in an Endemic Region of Ethiopia Diagnostics rk39 rapid diagnostic test direct agglutination test microscopy loop-mediated isothermal amplification miniature direct-on-blood polymerase chain reaction–nucleic acid lateral flow immunoassay diagnostics |
| title | Comparison of the Diagnostic Performances of Five Different Tests in Diagnosing Visceral Leishmaniasis in an Endemic Region of Ethiopia |
| title_full | Comparison of the Diagnostic Performances of Five Different Tests in Diagnosing Visceral Leishmaniasis in an Endemic Region of Ethiopia |
| title_fullStr | Comparison of the Diagnostic Performances of Five Different Tests in Diagnosing Visceral Leishmaniasis in an Endemic Region of Ethiopia |
| title_full_unstemmed | Comparison of the Diagnostic Performances of Five Different Tests in Diagnosing Visceral Leishmaniasis in an Endemic Region of Ethiopia |
| title_short | Comparison of the Diagnostic Performances of Five Different Tests in Diagnosing Visceral Leishmaniasis in an Endemic Region of Ethiopia |
| title_sort | comparison of the diagnostic performances of five different tests in diagnosing visceral leishmaniasis in an endemic region of ethiopia |
| topic | rk39 rapid diagnostic test direct agglutination test microscopy loop-mediated isothermal amplification miniature direct-on-blood polymerase chain reaction–nucleic acid lateral flow immunoassay diagnostics |
| url | https://www.mdpi.com/2075-4418/14/2/163 |
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