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New point-of-care (POC) tests are needed and assessing the performance of these tests for cutaneous leishmaniasis (CL) in Afghanistan may help increasing the number of CL patients with access to accurate diagnosis, and enable prompt treatment. Simpler tests could improve treatment access and benefit patients and communities, by reducing the risk of sequelae and the risk of disease transmission. CLeishPOCAFG aims to advance the diagnosis of CL by using more accurate and field-amenable methods.
The investigators enrolled 274 CL suspects in the study to determine the diagnostic performance of LoopampTM Leishmania Detection Kit and CL DetectTM Rapid Test for CL diagnosis in Afghanistan. The study was conducted at the National Malaria & Leishmaniasis Control Program (NMLCP) Leishmaniasis Clinic in Kabul, Afghanistan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CL suspects | Individuals with suggestive signs of cutaneous leishmaniasis presenting themselves at the National Malaria & Leishmaniasis Control Program (NMLCP) Leishmaniasis clinic in Kabul, Afghanistan. These will be tested by diagnostic tests under evaluation: i) LoopampTM Leishmania Detection Kit is a diagnostic test for Leishmania DNA detection ii) CL DetectTM Rapid Test is a diagnostic test for Leishmania antigen detection And their performance compared against a reference combining microscopy and PCR. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LoopampTM Leishmania Detection Kit | Diagnostic Test | LoopampTM Leishmania Detection Kit is a diagnostic test for Leishmania DNA detection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic performance of CL Detect RDT and Loopamp Leishmania Detection Kit | Sensitivity and Specificity of the two diagnostic tests | Through study completion, an average of 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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CL suspects attending the National Malaria & Leishmaniasis Control Program (NMLCP) Leishmaniasis clinic in Kabul will be invited to enroll the study. Samples from prospective participants will be subjected to standard diagnostic procedure (Giemsa's smear microscopy), as well as PCR (confirmation test to be performed at AMC, The Netherlands) and the two new tests under evaluation, in order to determine the diagnostic accuracy of LAMP and CL Detect.
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| Name | Affiliation | Role |
|---|---|---|
| Martijn Vink, MD, MPH | HealthNet TPO | Principal Investigator |
| Israel Cruz, PhD | Foundation for Innovative New Diagnostics | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22693548 | Background | Alvar J, Velez ID, Bern C, Herrero M, Desjeux P, Cano J, Jannin J, den Boer M; WHO Leishmaniasis Control Team. Leishmaniasis worldwide and global estimates of its incidence. PLoS One. 2012;7(5):e35671. doi: 10.1371/journal.pone.0035671. Epub 2012 May 31. | |
| 25223940 | Background | Eroglu F, Uzun S, Koltas IS. Comparison of clinical samples and methods in chronic cutaneous leishmaniasis. Am J Trop Med Hyg. 2014 Nov;91(5):895-900. doi: 10.4269/ajtmh.13-0582. Epub 2014 Sep 15. |
| Label | URL |
|---|---|
| WHO. Control of the Leishmaniases | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 23, 2018 | |
| Reset | Jan 15, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 23, 2018 | Jan 15, 2019 |
| ID | Term |
|---|---|
| D016773 | Leishmaniasis, Cutaneous |
| ID | Term |
|---|---|
| D007896 | Leishmaniasis |
| D056986 | Euglenozoa Infections |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
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Skin samples from cutaneous lesions obtained with a dental broach. Sample stored in lysis buffer accompanying the RDT kit. DNA extracted using commercial kit.
| CL DetectTM Rapid Test | Diagnostic Test | CL DetectTM Rapid Test is a diagnostic test for Leishmania antigen detection |
|
| 12843055 | Background | Marfurt J, Nasereddin A, Niederwieser I, Jaffe CL, Beck HP, Felger I. Identification and differentiation of Leishmania species in clinical samples by PCR amplification of the miniexon sequence and subsequent restriction fragment length polymorphism analysis. J Clin Microbiol. 2003 Jul;41(7):3147-53. doi: 10.1128/JCM.41.7.3147-3153.2003. |
| 23858338 | Background | Masmoudi A, Hariz W, Marrekchi S, Amouri M, Turki H. Old World cutaneous leishmaniasis: diagnosis and treatment. J Dermatol Case Rep. 2013 Jun 30;7(2):31-41. doi: 10.3315/jdcr.2013.1135. Print 2013 Jun 30. |
| 10871386 | Background | Notomi T, Okayama H, Masubuchi H, Yonekawa T, Watanabe K, Amino N, Hase T. Loop-mediated isothermal amplification of DNA. Nucleic Acids Res. 2000 Jun 15;28(12):E63. doi: 10.1093/nar/28.12.e63. |
| 17714672 | Background | Reithinger R, Dujardin JC, Louzir H, Pirmez C, Alexander B, Brooker S. Cutaneous leishmaniasis. Lancet Infect Dis. 2007 Sep;7(9):581-96. doi: 10.1016/S1473-3099(07)70209-8. |
| 29135995 | Background | De Silva G, Somaratne V, Senaratne S, Vipuladasa M, Wickremasinghe R, Wickremasinghe R, Ranasinghe S. Efficacy of a new rapid diagnostic test kit to diagnose Sri Lankan cutaneous leishmaniasis caused by Leishmania donovani. PLoS One. 2017 Nov 14;12(11):e0187024. doi: 10.1371/journal.pone.0187024. eCollection 2017. |
| D007239 |
| Infections |
| D012876 | Skin Diseases, Parasitic |
| D000079426 | Vector Borne Diseases |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |