{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,23]],"date-time":"2026-09-23T13:22:06Z","timestamp":1790169726877,"version":"4.1.0"},"reference-count":38,"publisher":"American Society of Tropical Medicine and Hygiene","issue":"3","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2018,9,5]]},"abstract":"<jats:p>In rural areas in Morocco, diagnosing cutaneous leishmaniasis (CL) can be challenging. We evaluated the accuracy of a rapid diagnostic test (RDT) based on antigen detection, CL Detect Rapid Test<jats:sup>\u2122<\/jats:sup> (Inbios International Inc., Seattle, WA), in this setting. We consecutively recruited patients with new skin ulcers in nine primary health centers. We took a dental broach sample for the RDT and two other tissue samples by scraping the border and center of the lesion with a scalpel and smearing it on a slide. We duplicated each smear by pressing a clean slide against it and processed the slides by microscopy, polymerase chain reaction (PCR) internal transcribed spacer 1, and kDNA minicircle PCR. In a subgroup with positive PCR, the <jats:italic>Leishmania<\/jats:italic> species was identified using PCR-restriction fragment length polymorphism and PCR-sequencing of <jats:italic>hsp70<\/jats:italic> genes. A participant with positive microscopy and\/or PCR was considered a confirmed CL case. We computed sensitivity (Se) and specificity (Sp) of the RDT compared with this reference standard (<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/ClinicalTrials.gov\" xlink:type=\"simple\">ClinicalTrials.gov<\/jats:ext-link> registration: NCT02979002). Between December 2016 and July 2017, we included 219 patients, 50% of them were under 18 years old. Rapid diagnostic test Se was 68% [95% confidence interval (CI): 61\u201374], Sp 94% [95% CI: 91\u201397], positive predictive value 95% [95% CI: 92\u201398], and negative predictive value 64% [95% CI: 58\u201370]. Despite its low Se, this novel RDT is a useful addition to clinical management of CL in Morocco, especially in isolated localities. Rapid diagnostic test\u2013positive lesions can be treated as CL; but when RDT negative, microscopy should be done in a second step. The Se of the RDT can probably be optimized by improving the sampling procedure.<\/jats:p>","DOI":"10.4269\/ajtmh.18-0066","type":"journal-article","created":{"date-parts":[[2018,7,10]],"date-time":"2018-07-10T07:00:23Z","timestamp":1531206023000},"page":"716-722","source":"Crossref","is-referenced-by-count":30,"title":["Accuracy of a Rapid Diagnostic Test Based on Antigen Detection for the Diagnosis of Cutaneous Leishmaniasis in Patients with Suggestive Skin Lesions in Morocco"],"prefix":"10.4269","volume":"99","author":[{"given":"Issam","family":"Bennis","sequence":"first","affiliation":[{"name":"National School of Public Health, Ministry of Health, Rabat, Morocco;"},{"name":"Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium;"},{"name":"Department of Biomedical Sciences, Faculty of Pharmaceutical, Biomedical and Veterinary Sciences, University of Antwerp, Antwerp, Belgium;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kristien","family":"Verdonck","sequence":"additional","affiliation":[{"name":"Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nora","family":"el Khalfaoui","sequence":"additional","affiliation":[{"name":"Laboratory of Parasitology, Faculty of Medicine and Pharmacy, University Hassan II of Casablanca, Casablanca, Morocco;"},{"name":"Research Team on Immunopathology of Infectious and Systemic Diseases, Faculty of Medicine and Pharmacy, University Hassan II of Casablanca, Casablanca, Morocco;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Myriam","family":"Riyad","sequence":"additional","affiliation":[{"name":"Laboratory of Parasitology, Faculty of Medicine and Pharmacy, University Hassan II of Casablanca, Casablanca, Morocco;"},{"name":"Research Team on Immunopathology of Infectious and Systemic Diseases, Faculty of Medicine and Pharmacy, University Hassan II of Casablanca, Casablanca, Morocco;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hajiba","family":"Fellah","sequence":"additional","affiliation":[{"name":"National Reference Laboratory of Leishmaniasis, Parasitology Department, National Institute of Hygiene, Rabat, Morocco;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean-Claude","family":"Dujardin","sequence":"additional","affiliation":[{"name":"Department of Biomedical Sciences, Faculty of Pharmaceutical, Biomedical and Veterinary Sciences, University of Antwerp, Antwerp, Belgium;"},{"name":"Department of Biomedical Sciences, Institute of Tropical Medicine, Antwerp, Belgium;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hamid","family":"Sahibi","sequence":"additional","affiliation":[{"name":"Department of Parasitology, Hassan II Agronomy, and Veterinary Institute, Rabat, Morocco;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Souad","family":"Bouhout","sequence":"additional","affiliation":[{"name":"Unit of Parasitic Diseases, Directorate of Epidemiology and Disease Control, Ministry of Health, Rabat, Morocco"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gert","family":"Van der Auwera","sequence":"additional","affiliation":[{"name":"Department of Biomedical Sciences, Institute of Tropical Medicine, Antwerp, Belgium;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marleen","family":"Boelaert","sequence":"additional","affiliation":[{"name":"Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium;"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"2795","reference":[{"key":"b1","series-title":"Parasite","first-page":"14","article-title":"Cutaneous leishmaniasis in North Africa: a review","volume":"21","author":"Aoun","year":"2014"},{"key":"b2","series-title":"Parasit Vectors","first-page":"612","article-title":"New epidemiological aspects of visceral and cutaneous leishmaniasis in Taza, Morocco","volume":"9","author":"Hakkour","year":"2016"},{"key":"b3","series-title":"J Infect Dis Ther","first-page":"46","article-title":"Epidemiology status of cutaneous leishmaniasis in Morocco","volume":"4","author":"Sebti","year":"2016"},{"key":"b4","series-title":"Infect Dis Poverty","first-page":"46","article-title":"Psychosocial impact of scars due to cutaneous leishmaniasis on high school students in Errachidia province, Morocco","volume":"6","author":"Bennis","year":"2017"},{"key":"b5","series-title":"PLoS Negl Trop Dis","first-page":"e0005090","article-title":"Psychological and psychosocial consequences of zoonotic cutaneous leishmaniasis among women in Tunisia: preliminary findings from an exploratory study","volume":"10","author":"Chahed","year":"2016"},{"key":"b6","series-title":"Facial Plast Surg Clin North Am","first-page":"481","article-title":"Use of makeup, hairstyles, glasses, and prosthetics as adjuncts to scar camouflage","volume":"19","author":"Sidle","year":"2011"},{"key":"b7","series-title":"Am J Clin Dermatol","first-page":"99","article-title":"Cutaneous leishmaniasis: recent developments in diagnosis and management","volume":"16","author":"de Vries","year":"2015"},{"key":"b8","series-title":"Zahedan J Res Med Sci","first-page":"1","article-title":"Comparison of traditional methods and PCR for diagnosis of cutaneous leishmaniasis in south-west of Iran","volume":"14","author":"Khademvatan","year":"2012"},{"key":"b9","series-title":"Trans R Soc Trop Med Hyg","first-page":"762","article-title":"Usefulness of PCR in the diagnosis of cutaneous leishmaniasis in Tunisia","volume":"99","author":"Chargui","year":"2005"},{"key":"b10","series-title":"Iran J Parasitol","first-page":"1","article-title":"Comparison of three methods for diagnosis of cutaneous leishmaniasis","volume":"5","author":"Pourmohammadi","year":"2010"},{"key":"b11","series-title":"Am J Trop Med Hyg","first-page":"906","article-title":"Diagnosis of cutaneous leishmaniasis in Guatemala using a real-time polymerase chain reaction assay and the Smartcycler","volume":"76","author":"Wortmann","year":"2007"},{"key":"b12","series-title":"PLoS Negl Trop Dis","first-page":"e2130","article-title":"Methodology of clinical trials aimed at assessing interventions for cutaneous leishmaniasis","volume":"7","author":"Olliaro","year":"2013"},{"key":"b13","series-title":"Arch Pathol Lab Med","first-page":"235","article-title":"Comparison of conventional, molecular, and immunohistochemical methods in diagnosis of typical and atypical cutaneous leishmaniasis","volume":"138","author":"Shirian","year":"2014"},{"key":"b14","series-title":"Parasit Vectors","first-page":"420","article-title":"Molecular diagnosis of cutaneous leishmaniasis and identification of the causative Leishmania species in Morocco by using three PCR-based assays","volume":"7","author":"Mouttaki","year":"2014"},{"key":"b15","series-title":"J Infect Dev Ctries","first-page":"115","article-title":"PCR detection of Leishmania in skin biopsies","volume":"3","author":"Lemrani","year":"2009"},{"key":"b16","series-title":"Interdiscip Perspect Infect Dis","first-page":"607287","article-title":"ITS1 PCR-RFLP diagnosis and characterization of Leishmania in clinical samples and strains from cases of human cutaneous leishmaniasis in states of the Mexican southeast","volume":"2014","author":"Monroy-Ostria","year":"2014"},{"key":"b17","series-title":"Acta Trop","first-page":"55","article-title":"Clinical diagnosis of cutaneous leishmaniasis: a comparison study between standardized graded direct microscopy and ITS1-PCR of Giemsa-stained smears","volume":"99","author":"Al-Jawabreh","year":"2006"},{"key":"b18","series-title":"Diagn Microbiol Infect Dis","first-page":"349","article-title":"PCR diagnosis and characterization of Leishmania in local and imported clinical samples","volume":"47","author":"Schonian","year":"2003"},{"key":"b19","author":"Directorate of Epidemiology and Diseases Control","year":"2010"},{"key":"b20","series-title":"PLoS Negl Trop Dis","first-page":"e0004655","article-title":"Rapid diagnostic tests for neglected infectious diseases: case study highlights need for customer awareness and postmarket surveillance","volume":"10","author":"Barbe","year":"2016"},{"key":"b21","series-title":"Nat Rev Micro","first-page":"S30","article-title":"Evaluation of rapid diagnostic tests: visceral leishmaniasis","volume":"5","author":"Boelaert","year":"2007"},{"key":"b22","series-title":"Cochrane Database Syst Rev","first-page":"CD009135","article-title":"Rapid tests for the diagnosis of visceral leishmaniasis in patients with suspected disease","volume":"6","author":"Boelaert","year":"2014"},{"key":"b23","series-title":"Clin Infect Dis","first-page":"1312","article-title":"A global comparative evaluation of commercial immunochromatographic rapid diagnostic tests for visceral leishmaniasis","volume":"55","author":"Cunningham","year":"2012"},{"key":"b24","series-title":"Acta Trop","first-page":"11","article-title":"New epidemiological pattern of cutaneous leishmaniasis in two pre-Saharan arid provinces, southern Morocco","volume":"173","author":"Ait Kbaich","year":"2017"},{"key":"b25","series-title":"Biomed Res Int","first-page":"8642373","article-title":"Geographical distribution and new situation of Leishmania species after the control of cutaneous leishmaniasis foci in Errachidia Province, Morocco, in 2014","volume":"2016","author":"Mohamed Mahmoud el","year":"2016"},{"key":"b26","series-title":"Acta Trop","first-page":"94","article-title":"Coexistence of Leishmania tropica and Leishmania infantum in Sefrou province, Morocco","volume":"130","author":"Hmamouch","year":"2014"},{"key":"b27","series-title":"Bull Soc Pathol Exot","first-page":"376","article-title":"Cutaneous leishmaniasis in Ouazzane and Sidi Kacem provinces, Morocco (1997\u20132012)","volume":"109","author":"El Miri","year":"2016"},{"key":"b28","series-title":"PLoS Negl Trop Dis","first-page":"e0003936","article-title":"Quantification of Leishmania (Viannia) kinetoplast DNA in ulcers of cutaneous leishmaniasis reveals inter-site and inter-sampling variability in parasite load","volume":"9","author":"Su\u00e1rez","year":"2015"},{"key":"b29","series-title":"J Microbiol Methods","first-page":"295","article-title":"Rapid differentiation of old world Leishmania species by LightCycler polymerase chain reaction and melting curve analysis","volume":"51","author":"Nicolas","year":"2002"},{"key":"b30","series-title":"BMJ Open","first-page":"e012799","article-title":"STARD 2015 guidelines for reporting diagnostic accuracy studies: explanation and elaboration","volume":"6","author":"Cohen","year":"2016"},{"key":"b31","series-title":"PLoS One","first-page":"e0187024","article-title":"Efficacy of a new rapid diagnostic test kit to diagnose Sri Lankan cutaneous leishmaniasis caused by Leishmania donovani","volume":"12","author":"De Silva","year":"2017"},{"key":"b32","series-title":"Trop Med Int Health","first-page":"45","article-title":"Evaluation of point-of-care tests for cutaneous leishmaniasis diagnosis in Afghanistan","volume":"22","author":"Vink","year":"2017"},{"key":"b33","author":"Aerts","year":"2017"},{"key":"b34","series-title":"Parasit Vectors","first-page":"591","article-title":"Development of loop-mediated isothermal amplification (LAMP) for simple detection of Leishmania infection","volume":"8","author":"Sriworarat","year":"2015"},{"key":"b35","series-title":"Acta Trop","first-page":"116","article-title":"A rapid molecular diagnosis of cutaneous leishmaniasis by colorimetric malachite green-loop-mediated isothermal amplification (LAMP) combined with an FTA card as a direct sampling tool","volume":"153","author":"Nzelu","year":"2016"},{"key":"b36","series-title":"Parasitol Int","first-page":"34","article-title":"Non-invasive diagnosis of cutaneous leishmaniasis by the direct boil loop-mediated isothermal amplification method and MinION\u2122 nanopore sequencing","volume":"67","author":"Imai","year":"2018"},{"key":"b37","series-title":"Am J Trop Med Hyg","first-page":"591","article-title":"Development of a reverse transcriptase loop-mediated isothermal amplification (LAMP) assay for the sensitive detection of Leishmania parasites in clinical samples","volume":"82","author":"Adams","year":"2010"},{"key":"b38","series-title":"PLoS Negl Trop Dis","first-page":"e0005750","article-title":"A novel non-invasive diagnostic sampling technique for cutaneous leishmaniasis","volume":"11","author":"Taslimi","year":"2017"}],"container-title":["The American Journal of Tropical Medicine and Hygiene"],"original-title":[],"link":[{"URL":"https:\/\/www.ajtmh.org\/view\/journals\/tpmd\/99\/3\/article-p716.xml","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.ajtmh.org\/downloadpdf\/journals\/tpmd\/99\/3\/article-p716.xml","content-type":"text\/html","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/www.ajtmh.org\/downloadpdf\/journals\/tpmd\/99\/3\/article-p716.xml","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,7,31]],"date-time":"2024-07-31T19:51:14Z","timestamp":1722455474000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.ajtmh.org\/view\/journals\/tpmd\/99\/3\/article-p716.xml"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,9,5]]},"references-count":38,"journal-issue":{"issue":"3"},"URL":"https:\/\/doi.org\/10.4269\/ajtmh.18-0066","relation":{},"ISSN":["0002-9637","1476-1645"],"issn-type":[{"value":"0002-9637","type":"print"},{"value":"1476-1645","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,9,5]]}}}