Evaluation of Loopamp Leishmania detection kit for the diagnosis of cutaneous leishmaniasis in Ethiopia.

Autor: Taye B; Department of Immunology and Molecular Biology, University of Gondar, Gondar, Ethiopia. behailutaye096@gmail.com.; Department of Medical Laboratory Science, Dilla University, Dilla, Ethiopia. behailutaye096@gmail.com., Melkamu R; Leishmaniasis Research and Treatment Center, University of Gondar, Gondar, Ethiopia., Tajebe F; Department of Immunology and Molecular Biology, University of Gondar, Gondar, Ethiopia., Ibarra-Meneses AV; Département de Pathologie et Microbiologie, Faculté de Médecine Vétérinaire, Université de Montréal, Saint-Hyacinthe, QC, Canada., Adane D; Leishmaniasis Research and Treatment Center, University of Gondar, Gondar, Ethiopia., Atnafu S; Leishmaniasis Research and Treatment Center, University of Gondar, Gondar, Ethiopia., Adem M; Department of Immunology and Molecular Biology, University of Gondar, Gondar, Ethiopia., Adane G; Department of Immunology and Molecular Biology, University of Gondar, Gondar, Ethiopia., Kassa M; Leishmaniasis Research and Treatment Center, University of Gondar, Gondar, Ethiopia., Asres MS; Leishmaniasis Research and Treatment Center, University of Gondar, Gondar, Ethiopia., van Griensven J; Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium., van Henten S; Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium., Pareyn M; Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium.
Jazyk: angličtina
Zdroj: Parasites & vectors [Parasit Vectors] 2024 Oct 15; Vol. 17 (1), pp. 431. Date of Electronic Publication: 2024 Oct 15.
DOI: 10.1186/s13071-024-06475-3
Abstrakt: Background: Cutaneous leishmaniasis (CL) in Ethiopia and some parts of Kenya is predominantly caused by Leishmania aethiopica. While skin-slit (SS) microscopy is routinely used for CL diagnosis, more sensitive molecular tests are available. The Loopamp™ Leishmania detection kit (Loopamp) is a robust loop-mediated isothermal amplification (LAMP) assay with the potential for implementation in primary healthcare facilities. In this study, we comparatively assessed the diagnostic accuracy of four methods currently used to diagnose CL: Loopamp, kinetoplast DNA (kDNA) PCR, spliced leader RNA (SL-RNA) PCR and SS microscopy.
Methods: A study on 122 stored tape disc samples of suspected CL patients was conducted in Gondar, northwestern Ethiopia. Routine SS microscopy results were obtained from all patients. Total nucleic acids were extracted from the tapes and subjected to PCR testing targeting kDNA and SL-RNA, and Loopamp. Diagnostic accuracy was calculated with SS microscopy as a reference test. The limit of detection (LoD) of Loopamp and kDNA PCR were determined for cultured L. aethiopica and Leishmania donovani.
Results: Of the 122 patients, 64 (52.5%) were identified as CL cases based on SS microscopy. Although the PCR tests showed a sensitivity of 95.3% (95% confidence interval [CI] 91.6-99.1), Loopamp only had 48.4% (95% CI 39.6-57.3) sensitivity and 87.9% (95% CI 82.1-93.7) specificity. The LoD of Loopamp for L. donovani was 100-fold lower (20 fg/µl) than that for L. aethiopica (2 pg/µl).
Conclusions: The Loopamp™ Leishmania detection kit is not suitable for the diagnosis of CL in Ethiopia, presumably due to a primer mismatch with the L. aethiopica 18S rRNA target. Further research is needed to develop a simple and sensitive point-of-care test that allows the decentralization of CL diagnosis in Ethiopia.
(© 2024. The Author(s).)
Databáze: MEDLINE
Externí odkaz:
Nepřihlášeným uživatelům se plný text nezobrazuje