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

Publisher: Public Library of Science Country of Publication: United States NLM ID: 101291488 Publication Model: eCollection Cited Medium: Internet ISSN: 1935-2735 (Electronic) Linking ISSN: 19352727 NLM ISO Abbreviation: PLoS Negl Trop Dis Subsets: MEDLINE

Original Publication: San Francisco, CA : Public Library of Science

Leishmania/*genetics ; Leishmania/*isolation & purification ; Leishmaniasis, Cutaneous/*diagnosis ; Molecular Diagnostic Techniques/*methods; Adolescent ; Adult ; Aged ; Aged, 80 and over ; Child ; Child, Preschool ; Chromatography, Affinity ; Colombia ; Cross-Sectional Studies ; DNA Primers/genetics ; DNA, Kinetoplast/genetics ; DNA, Protozoan/genetics ; Female ; Humans ; Male ; Middle Aged ; Nucleic Acid Amplification Techniques ; Sensitivity and Specificity ; Young Adult

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.
Competing Interests: The authors have declared that no competing interests exist.

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D43 TW006589 United States TW FIC NIH HHS

ClinicalTrials.gov NCT04500873

0 (DNA Primers)
0 (DNA, Kinetoplast)
0 (DNA, Protozoan)

Date Created: 20210428 Date Completed: 20210729 Latest Revision: 20210729

20240104

PMC8081229

10.1371/journal.pntd.0009291

33909619