A Diagnostic Algorithm Based on Urine Antigen and Blood Polymerase Chain Reaction Testing for Visceral Leishmaniasis in HIV-Coinfected Patients in Northwest Ethiopia
5 affiliations
- 1Department of General Internal Medicine, University of Washington, Seattle, Washington, USA
- 2Leishmaniasis Research and Treatment Center, University of Gondar, Gondar, Ethiopia
- 3Médecins sans Frontières, Amsterdam, The Netherlands
- 4Institute of Tropical Medicine, Antwerp, Belgium
- 5Médecins sans Frontières, Abdurafi, Ethiopia
Abstract
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, Leishmania 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, Leishmania 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.
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BibTeX
@article{diro2026diagnostic,
title = {{A Diagnostic Algorithm Based on Urine Antigen and Blood Polymerase Chain Reaction Testing for Visceral Leishmaniasis in HIV-Coinfected Patients in Northwest Ethiopia}},
author = {Ermias Diro and Koert Ritmeijer and Saskia van Henten and Aderajew Kibret and Mekibib Kassa and Hailemariam Beyene and Wim Adriaensen and Myrthe Pareyn and Johan van Griensven},
journal = {The American Journal of Tropical Medicine and Hygiene},
year = {2026},
month = sep,
doi = {10.4269/ajtmh.26-0104},
url = {https://doi.org/10.4269/ajtmh.26-0104},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - A Diagnostic Algorithm Based on Urine Antigen and Blood Polymerase Chain Reaction Testing for Visceral Leishmaniasis in HIV-Coinfected Patients in Northwest Ethiopia
AU - Ermias Diro
AU - Koert Ritmeijer
AU - Saskia van Henten
AU - Aderajew Kibret
AU - Mekibib Kassa
AU - Hailemariam Beyene
AU - Wim Adriaensen
AU - Myrthe Pareyn
AU - Johan van Griensven
PY - 2026
DA - 2026/09/15
JO - The American Journal of Tropical Medicine and Hygiene
DO - 10.4269/ajtmh.26-0104
UR - https://doi.org/10.4269/ajtmh.26-0104
AB - 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, Leishmania 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, Leishmania 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.
SN - 0002-9637
SN - 1476-1645
ER -