Dataset Information

Diagnostic performance of a Recombinant Polymerase Amplification Test-Lateral Flow (RPA-LF) for cutaneous leishmaniasis in an endemic setting of Colombia.

ABSTRACT:

Background

Control of cutaneous leishmaniasis by public health systems in the Americas relies on case identification and treatment. Point-of-care diagnostics that can be performed by health workers within or near affected communities could effectively bring the health system to the resource-limited sites providing early diagnosis and treatment, reducing morbidity and the burden of disease.

Methodology/principal findings

A cross-sectional study was undertaken to evaluate the diagnostic test performance of Isothermal Recombinase Polymerase Amplification (RPA) targeting Leishmania kinetoplast DNA, coupled with a lateral flow (LF) immunochromatographic strip, in a field setting and a laboratory reference center. Minimally invasive swab and FTA filter paper samples were obtained by community health workers and highly trained technicians from ulcerated lesions of > 2 weeks' evolution from 118 patients' ≥ 2 years of age in the municipality of Tumaco, Nariño. Extracted DNA was processed by RPA-LF at a reference center or in a primary health facility in the field. Evaluation was based on a composite "gold standard" that included microscopy, culture, biopsy and real-time polymerase chain reaction detection of Leishmania 18S rDNA. Standard of care routine diagnostic tests were explored as comparators. Sensitivity and specificity of RPA-LF in the reference lab scenario were 87% (95%CI 74-94) and 86% (95%CI 74-97), respectively. In the field scenario, the sensitivity was 75% (95%CI 65-84) and specificity 89% (95%CI 78-99). Positive likelihood ratios in both scenarios were higher than 6 while negative likelihood ratios ranged to 0.2-0.3 supporting the usefulness of RPA-LF to rule-in and potentially to rule-out infection.

Conclusions/significance

The low complexity requirements of RPA-LF combined with non-invasive sampling support the feasibility of its utilization by community health workers with the goal of strengthening the diagnostic capacity for cutaneous leishmaniasis in Colombia.

Trial registration

ClinicalTrials.gov NCT04500873.

SUBMITTER: Cossio A

PROVIDER: S-EPMC8081229 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ImportanceLeishmaniasis is recognized as an endemic human disease in Africa, the Middle East, Asia, and South America. Yet despite case reports of endemic human leishmaniasis in the United States, and well-documented occurrences of disease in various animal vectors and reservoirs, the endemicity of leishmaniasis in North America has not yet been established. Moreover, leishmaniasis is not a federally reportable disease in the United States. Clinical awareness of endemic disease therefore remains low, with North American physicians considering leishmaniasis a tropical disease.ObjectiveTo assess the endemicity of human leishmaniasis in the United States.Design, setting, and participantsThis cross-sectional multicenter observational study reviewed cases of human leishmaniasis occurring in the United States from 2007 through 2017. Previously diagnosed, deidentified cases of leishmaniasis were reported by the institutions of the authors and acknowledged contributors, as well as the Texas Department of State Health Services. Cases of leishmaniasis were identified by searching by disease name (leishmaniasis) or International Classification of Diseases, 9th and 10th Revisions diagnosis codes in the respective laboratory information systems.ExposuresVia examination of deidentified demographics, cases of leishmaniasis were classified as one of the following: (1) documentation of no history of travel outside of the United States within 10 years; (2) positive history of travel outside of the United States within 10 years; or (3) unknown or no documentation of travel history.Main outcomes and measuresCases of leishmaniasis were considered endemic if identified in patients with documentation of no travel history outside of the United States within 10 years.ResultsOf the 69 novel cases of human cutaneous leishmaniasis identified in this study, 41 (59%) were endemic; the median age at diagnosis was 61 years (range, 3-89 years), and 28 (68%) of the endemic cases occurred in female patients. Twenty-two (32%) cases had documentation of Leishmania speciation performed by polymerase chain reaction, and in 100% of these cases the infectious organism was identified as Leishmania mexicana.Conclusions and relevanceHuman cutaneous leishmaniasis is endemic in the United States, and, at least regionally, is acquired endemically more frequently than it is via travel. Our data argue in favor of making leishmaniasis a federally reportable disease and may have substantial implications on North American public health initiatives, with climate models predicting the number of citizens exposed to leishmaniasis will double by 2080.