{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,15]],"date-time":"2026-09-15T20:03:06Z","timestamp":1789502586410,"version":"build-2803163510"},"reference-count":28,"publisher":"American Society of Tropical Medicine and Hygiene","license":[{"start":{"date-parts":[[2026,9,15]],"date-time":"2026-09-15T00:00:00Z","timestamp":1789430400000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,9,15]]},"abstract":"<jats:title>ABSTRACT.<\/jats:title>\n                  <jats:p>\n                    The diagnosis of visceral leishmaniasis (VL) in HIV patients relies on tissue aspiration, which is potentially life-threatening. Because antibody-based tests are unreliable for this group,\n                    <jats:italic>Leishmania<\/jats:italic>\n                    blood polymerase chain reaction (PCR) and urine antigen tests can serve as noninvasive alternatives. Using data from the PreLeisH cohort (ClinicalTrials.gov [NCT03013673]), the diagnostic accuracy of these two tests was determined individually, and an algorithm was designed for targeted tissue aspiration. Of the 490 PreLeish participants, 51 underwent diagnostic procedures for VL 118 times at different follow-up time points when clinically suspected. Of these, 48 (94.1%) patients with 102 (84.4%) procedures had complete data, including tissue aspiration,\n                    <jats:italic>Leishmania<\/jats:italic>\n                    kinetoplast DNA blood PCR, and urine antigen (KAtex [Kalon Biological Ltd., Guildford, United Kingdom]) results. The diagnostic performance of KAtex and blood PCR testing was assessed individually against tissue aspiration, and sequential and parallel algorithms were developed. Visceral leishmaniasis was confirmed via tissue microscopy in 55\/102 (54%) episodes. The sensitivity and specificity of blood PCR testing were 98% and 64%, respectively; the sensitivity and specificity of KAtex testing were 93% and 81%, respectively. A sequential algorithm using KAtex first and restricting PCR to KAtex-negative suspects limited PCR testing to 42 (41.2%) episodes and tissue aspiration to 14 (13.7%) episodes, with sensitivity, specificity, and positive predictive value of 100%, 81%, and 86%, respectively. The parallel testing algorithm exhibited comparable performance but requires PCR testing for all suspects. The sequential KAtex and PCR testing algorithm, combined with targeted tissue aspiration, met the WHO target product profile, except for specificity. This approach supports efficient resource use and reduces the need for invasive procedures.\n                  <\/jats:p>","DOI":"10.4269\/ajtmh.26-0104","type":"journal-article","created":{"date-parts":[[2026,9,15]],"date-time":"2026-09-15T19:08:25Z","timestamp":1789499305000},"source":"Crossref","is-referenced-by-count":0,"title":["A Diagnostic Algorithm Based on Urine Antigen and Blood Polymerase Chain Reaction Testing for Visceral Leishmaniasis in HIV-Coinfected Patients in Northwest Ethiopia"],"prefix":"10.4269","author":[{"given":"Ermias","family":"Diro","sequence":"first","affiliation":[{"name":"Department of General Internal Medicine, University of Washington, Seattle, Washington, USA;"},{"name":"Leishmaniasis Research and Treatment Center, University of Gondar, Gondar, Ethiopia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Koert","family":"Ritmeijer","sequence":"additional","affiliation":[{"name":"M\u00e9decins sans Fronti\u00e8res, Amsterdam, The Netherlands;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Saskia","family":"van Henten","sequence":"additional","affiliation":[{"name":"Institute of Tropical Medicine, Antwerp, Belgium;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aderajew","family":"Kibret","sequence":"additional","affiliation":[{"name":"M\u00e9decins sans Fronti\u00e8res, Abdurafi, Ethiopia;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mekibib","family":"Kassa","sequence":"additional","affiliation":[{"name":"Leishmaniasis Research and Treatment Center, University of Gondar, Gondar, Ethiopia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hailemariam","family":"Beyene","sequence":"additional","affiliation":[{"name":"M\u00e9decins sans Fronti\u00e8res, Abdurafi, Ethiopia;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wim","family":"Adriaensen","sequence":"additional","affiliation":[{"name":"Institute of Tropical Medicine, Antwerp, Belgium;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Myrthe","family":"Pareyn","sequence":"additional","affiliation":[{"name":"Institute of Tropical Medicine, Antwerp, Belgium;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Johan","family":"van Griensven","sequence":"additional","affiliation":[{"name":"Institute of Tropical Medicine, Antwerp, Belgium;"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"2795","reference":[{"issue":"2","key":"b1","series-title":"Infect Dis Clin North Am","first-page":"309","article-title":"Visceral leishmaniasis","volume":"26","author":"van Griensven","year":"2012"},{"key":"b2","article-title":"Leishmaniasis.","year":"2023"},{"issue":"3","key":"b3","series-title":"Acta Parasitol","first-page":"1704","article-title":"The elimination status of visceral leishmaniasis in Southeast Asia Region","volume":"69","author":"Rahim","year":"2024"},{"key":"b4","article-title":"Leishmaniasis.","year":"2025"},{"key":"b5","article-title":"Strategic Framework for the Elimination of Visceral Leishmaniasis as a Public Health Problem in Eastern Africa 2023\u20132030.","year":"2024"},{"issue":"1","key":"b6","series-title":"Clin Infect Dis","first-page":"240","article-title":"Chronic high-level parasitemia in HIV\u2013infected individuals with or without visceral leishmaniasis in an endemic area in Northwest Ethiopia: Potential superspreaders?","volume":"79","author":"van Griensven","year":"2024"},{"key":"b7","series-title":"Rapid Tests for the Diagnosis of Visceral Leishmaniasis in Patients with Suspected Disease","author":"Boelaert","year":"2014"},{"key":"b8","series-title":"Leishmaniasis Diagnosis: An Update on the Use of Parasitological, Immunological and Molecular Methods","author":"Thakur","year":"2020"},{"issue":"5","key":"b9","series-title":"PLoS Negl Trop Dis","first-page":"e1665","article-title":"The diagnostic accuracy of serologic and molecular methods for detecting visceral leishmaniasis in HIV infected patients: Meta-analysis","volume":"6","author":"Cota","year":"2012"},{"issue":"6","key":"b10","series-title":"PLoS Negl Trop Dis","first-page":"e2869","article-title":"Visceral leishmaniasis and HIV coinfection in East Africa","volume":"8","author":"Diro","year":"2014"},{"key":"b11","article-title":"WHO Guidelines for the Treatment of Visceral Leishmaniasis in HIV Co-infected Patients in East Africa and South-East Asia.","year":"2022"},{"key":"b12","article-title":"Target Product Profile for a Diagnostic Test to Confirm Visceral Leishmaniasis.","year":"2024"},{"issue":"4","key":"b13","series-title":"Am J Trop Med Hyg","first-page":"957","article-title":"Antigen detection in urine for noninvasive diagnosis and treatment monitoring of visceral leishmaniasis in human immunodeficiency virus coinfected patients: An exploratory analysis from Ethiopia","volume":"99","author":"Vogt","year":"2018"},{"key":"b14","series-title":"Front Cell Infect Microbiol","first-page":"94","article-title":"Leishmania antigenuria to predict initial treatment failure and relapse in Visceral Leishmaniasis\/HIV coinfected patients: An exploratory study nested within a clinical trial in Ethiopia","volume":"8","author":"van Griensven","year":"2018"},{"key":"b15","series-title":"EBioMedicine","first-page":"105474","article-title":"Prediction of visceral leishmaniasis development in a highly exposed HIV cohort in Ethiopia based on Leishmania infection markers: Results from the PreLeisH study","volume":"110","author":"van Griensven","year":"2024"},{"issue":"4","key":"b16","series-title":"Trans R Soc Trop Med Hyg","first-page":"578","article-title":"Detection of Leishmania donovani soluble antigen and antibody in the urine of visceral leishmaniasis patients","volume":"81","author":"Kohanteb","year":"1987"},{"issue":"1","key":"b17","series-title":"Acta Trop","first-page":"11","article-title":"Latex agglutination test for the detection of urinary antigens in visceral leishmaniasis","volume":"78","author":"Attar","year":"2001"},{"issue":"3","key":"b18","series-title":"J Clin Microbiol","first-page":"849","article-title":"Development of a species-specific PCR assay for detection of Leishmania donovani in clinical samples from patients with kala-azar and post-kala-azar dermal leishmaniasis","volume":"39","author":"Salotra","year":"2001"},{"key":"b19","series-title":"Biomed Res Int","first-page":"1","article-title":"Comparison between conventional and real-time PCR assays for diagnosis of visceral leishmaniasis","volume":"2014","author":"Pereira","year":"2014"},{"key":"b20","year":"2013"},{"issue":"2","key":"b21","series-title":"PLoS Negl Trop Dis","first-page":"e0011128","article-title":"PCR for detection of Leishmania donovani from microscopically negative tissue smears of suspected patients in Gondar, Ethiopia","volume":"17","author":"Melkamu","year":"2023"},{"issue":"9","key":"b22","series-title":"Trans R Soc Trop Med Hyg","first-page":"908","article-title":"Field evaluation of FD-DAT, rK39 dipstick and KATEX (urine latex agglutination) for diagnosis of visceral leishmaniasis in northwest Ethiopia","volume":"101","author":"Diro","year":"2007"},{"key":"b23","article-title":"Control of the Leishmaniases: WHO TRS N\u00b0949: Report of a Meeting of the WHO Expert Committee on the Control of Leishmaniases, Geneva, 22\u201326 March 2010.","year":"2010"},{"issue":"5","key":"b24","series-title":"PLoS Negl Trop Dis","first-page":"e0003738","article-title":"Impact of the use of a rapid diagnostic test for visceral leishmaniasis on clinical practice in Ethiopia: A retrospective study","volume":"9","author":"Diro","year":"2015"},{"issue":"2","key":"b25","series-title":"PLoS Negl Trop Dis","first-page":"e0006264","article-title":"Sensitive and less invasive confirmatory diagnosis of visceral leishmaniasis in Sudan using loop-mediated isothermal amplification (LAMP)","volume":"12","author":"Mukhtar","year":"2018"},{"issue":"7","key":"b26","series-title":"J Clin Microbiol","first-page":"e00386-18","article-title":"Development and evaluation of a novel loop-mediated isothermal amplification assay for diagnosis of cutaneous and visceral leishmaniasis","volume":"56","author":"Adams","year":"2018"},{"key":"b27","series-title":"Curr Ther Res Clin Exp","first-page":"100583","article-title":"Multiple relapses of visceral leishmaniasis in HIV co-infected patients: A case series from Ethiopia","volume":"92","author":"Mohammed","year":"2020"},{"issue":"10","key":"b28","series-title":"PLoS Negl Trop Dis","first-page":"e0004087","article-title":"Use of pentamidine as secondary prophylaxis to prevent visceral leishmaniasis relapse in HIV Infected patients, the first twelve months of a prospective cohort study","volume":"9","author":"Diro","year":"2015"}],"container-title":["The American Journal of Tropical Medicine and 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