{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,20]],"date-time":"2026-10-20T16:23:08Z","timestamp":1792513388219,"version":"4.5.0"},"reference-count":13,"publisher":"Oxford University Press (OUP)","issue":"12","license":[{"start":{"date-parts":[[2021,5,26]],"date-time":"2021-05-26T00:00:00Z","timestamp":1621987200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"funder":[{"DOI":"10.13039\/501100003545","name":"Ministry of Science, Technology and Innovation","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100003545","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2021,12,2]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>The diagnosis of cutaneous leishmaniasis (CL) is based on demonstration of the presence of the parasite in samples obtained from the lesions by direct examination (DE), culture or polymerase chain reaction (PCR)-based molecular tests. Recombinase polymerase amplification (RPA) represents an isothermal version of the conventional PCR (cPCR) technique, being ideal for detecting Leishmania DNA, especially in field conditions.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>A prospective and cross-sectional study was conducted to evaluate the diagnostic performance of RPA in the health centres of rural endemic sites or the evaluation centre (EC) of 11 Colombian municipalities and in a reference centre (RC).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Samples of 128 patients with suspected CL were included and processed for analysis by RPA vs DE in the EC and RPA vs DE and cPCR in the RC. The RPA performed at the EC was more sensitive (90.4% [95% confidence interval {CI} 81.9 to 95.7]) than the DE (42\u201367%) and the specificity was 72.7% (95% CI 57.2 to 85.0). Both the sensitivity and specificity increased to 100% when adjusting by the imperfect reference standard analysis method. In the RC, the sensitivity of RPA vs cPCR was 72% and the specificity was 69.8%, while the sensitivity of cPCR vs the DE test was 78.8% and the specificity was 81%.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>The higher sensitivity and specificity shown by RPA in the EC, but also its ease and speed of use, justify performing RPA in the health centres of rural endemic sites. In addition, RPA eliminates the subjectivity inherent in the traditional DE.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/trstmh\/trab073","type":"journal-article","created":{"date-parts":[[2021,4,23]],"date-time":"2021-04-23T20:26:24Z","timestamp":1619209584000},"page":"1427-1433","source":"Crossref","is-referenced-by-count":5,"title":["The performance of the recombinase polymerase amplification test for detecting <i>Leishmania<\/i> deoxyribonucleic acid from skin lesions of patients with clinical or epidemiological suspicion of cutaneous leishmaniasis"],"prefix":"10.1093","volume":"115","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3556-8977","authenticated-orcid":false,"given":"Luz Estella","family":"Mesa","sequence":"first","affiliation":[{"name":"PECET-Program for the Study and Control of Tropical Diseases. Faculty of Medicine, Universidad de Antioquia-UdeA, Medell\u00edn, Colombia"},{"name":"Epidemiology and Biostatistic Universidad CES, Medell\u00edn, Colombia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2561-1989","authenticated-orcid":false,"given":"Rub\u00e9n","family":"Manrique","sequence":"additional","affiliation":[{"name":"Epidemiology and Biostatistic Universidad CES, Medell\u00edn, Colombia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2752-4931","authenticated-orcid":false,"given":"Sara M","family":"Robledo","sequence":"additional","affiliation":[{"name":"PECET-Program for the Study and Control of Tropical Diseases. Faculty of Medicine, Universidad de Antioquia-UdeA, Medell\u00edn, Colombia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9657-812X","authenticated-orcid":false,"given":"Jessica","family":"Tabares","sequence":"additional","affiliation":[{"name":"PECET-Program for the Study and Control of Tropical Diseases. Faculty of Medicine, Universidad de Antioquia-UdeA, Medell\u00edn, Colombia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0703-5938","authenticated-orcid":false,"given":"Tatiana","family":"Pineda","sequence":"additional","affiliation":[{"name":"PECET-Program for the Study and Control of Tropical Diseases. Faculty of Medicine, Universidad de Antioquia-UdeA, Medell\u00edn, Colombia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carlos","family":"Muskus","sequence":"additional","affiliation":[{"name":"PECET-Program for the Study and Control of Tropical Diseases. Faculty of Medicine, Universidad de Antioquia-UdeA, Medell\u00edn, Colombia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2021,5,26]]},"reference":[{"issue":"5","key":"2021120506553598400_bib1","doi-asserted-by":"crossref","first-page":"e35671","DOI":"10.1371\/journal.pone.0035671","article-title":"Leishmaniasis worldwide and global estimates of its incidence","volume":"7","author":"Alvar","year":"2012","journal-title":"PLoS One"},{"key":"2021120506553598400_bib2","first-page":"ED000055","article-title":"Cochrane reviews on neglected diseases: the case of cutaneous leishmaniasis","volume":"3","author":"Gonz\u00e1lez","year":"2013","journal-title":"Cochrane Database Syst Rev"},{"issue":"2","key":"2021120506553598400_bib3","doi-asserted-by":"crossref","first-page":"181","DOI":"10.2307\/3285616","article-title":"PCR detection and identification of Leishmania parasites in clinical specimens in Ecuador: a comparison with classical diagnostic methods","volume":"85","author":"Aviles","year":"1999","journal-title":"J Parasitol"},{"issue":"2","key":"2021120506553598400_bib4","doi-asserted-by":"crossref","first-page":"601","DOI":"10.1128\/JCM.40.2.601-606.2002","article-title":"PCR-based diagnosis of acute and chronic cutaneous leishmaniasis caused by Leishmania (Viannia)","volume":"40","author":"Weigle","year":"2002","journal-title":"J Clin Microbiol"},{"issue":"2","key":"2021120506553598400_bib5","doi-asserted-by":"crossref","first-page":"133","DOI":"10.1016\/S0035-9203(96)90112-1","article-title":"Evaluation of the polymerase chain reaction in the diagnosis of cutaneous leishmaniasis due to Leishmania major: a comparison with direct microscopy of smears and sections from lesions","volume":"90","author":"Andresen","year":"1996","journal-title":"Trans R Soc Trop Med Hyg"},{"issue":"10","key":"2021120506553598400_bib6","doi-asserted-by":"crossref","first-page":"3572","DOI":"10.1128\/JCM.40.10.3572-3576.2002","article-title":"Evaluation of PCR for diagnosis of American cutaneous leishmaniasis in an area of endemicity in northeastern Brazil","volume":"40","author":"Rodrigues","year":"2002","journal-title":"J Clin Microbiol"},{"issue":"1","key":"2021120506553598400_bib7","doi-asserted-by":"crossref","first-page":"77","DOI":"10.5578\/mb.8344","article-title":"Comparison of direct microscopy, culture and polymerase chain reaction methods for the diagnosis of cutaneous leishmaniasis]","volume":"49","author":"Ertabaklar","year":"2015","journal-title":"Mikrobiyol Bul"},{"issue":"1","key":"2021120506553598400_bib8","doi-asserted-by":"crossref","first-page":"55","DOI":"10.1016\/j.actatropica.2006.07.001","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","journal-title":"Acta Trop"},{"issue":"2","key":"2021120506553598400_bib9","first-page":"97","article-title":"Diagnosis of cutaneous leishmaniasis","volume":"16","author":"Vega-L\u00f3pez","year":"2003","journal-title":"Infect Dis"},{"issue":"11","key":"2021120506553598400_bib10","doi-asserted-by":"crossref","first-page":"665","DOI":"10.1186\/s13071-018-3238-1","article-title":"Evaluation of rapid extraction and isothermal amplification techniques for the detection of Leishmania donovani DNA from skin lesions of suspected cases at the point of need in Sri Lanka","volume":"11","author":"Gunaratna","year":"2018","journal-title":"Parasit Vectors"},{"key":"2021120506553598400_bib11","doi-asserted-by":"crossref","first-page":"e012799","DOI":"10.1136\/bmjopen-2016-012799","article-title":"STARD 2015 guidelines for reporting diagnostic accuracy studies: explanation and elaboration","volume":"6","author":"Cohen","year":"2016","journal-title":"BMJ Open"},{"issue":"7","key":"2021120506553598400_bib12","doi-asserted-by":"crossref","first-page":"1843","DOI":"10.1007\/s00436-017-5454-6","article-title":"Detection and identification of Leishmania spp.: application of two hsp70-based PCR-RFLP protocols to clinical samples from the New World","volume":"116","author":"Montalvo","year":"2017","journal-title":"Parasitol Res"},{"issue":"2","key":"2021120506553598400_bib13","first-page":"108","article-title":"Diagn\u00f3stico de la leishmaniasis: de la observaci\u00f3n microsc\u00f3pica del par\u00e1sito a la detecci\u00f3n del ADN","volume":"64","author":"Montalvo","year":"2012","journal-title":"Rev Cubana Med Trop"}],"container-title":["Transactions of The Royal Society of Tropical Medicine and Hygiene"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/trstmh\/article-pdf\/115\/12\/1427\/41470256\/trab073.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/trstmh\/article-pdf\/115\/12\/1427\/41470256\/trab073.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,12,5]],"date-time":"2021-12-05T06:55:56Z","timestamp":1638687356000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/trstmh\/article\/115\/12\/1427\/6284914"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,5,26]]},"references-count":13,"journal-issue":{"issue":"12","published-online":{"date-parts":[[2021,5,26]]},"published-print":{"date-parts":[[2021,12,2]]}},"URL":"https:\/\/doi.org\/10.1093\/trstmh\/trab073","relation":{},"ISSN":["0035-9203","1878-3503"],"issn-type":[{"value":"0035-9203","type":"print"},{"value":"1878-3503","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2021,12]]},"published":{"date-parts":[[2021,5,26]]}}}