Sistema de Salut de Catalunya
Institut Català de la Salut
[Bezemer JM] Hospital Shell, Fundación Misión Cristiana de Salud, Shell, Pastaza, Ecuador. Department of Medical Microbiology and Infection Prevention, Laboratory for Experimental Parasitology, Amsterdam University Medical Centers location Academic Medical Center at the University of Amsterdam, Amsterdam, the Netherlands. Amsterdam Institute for infection and Immunity, Infectious Diseases Program, Amsterdam, the Netherlands. [Merckx J] Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Canada. Department of Epidemiology and Data Science, Amsterdam UMC location University of Amsterdam, Amsterdam, the Netherlands. [Freire Paspuel BP] Laboratorios de Investigación, Universidad de las Américas, Quito, Ecuador. Vall d’Hebron Institut de Recerca (VHIR), Barcelona, Spain. Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Calvopiña M] OneHealth Research Group, Facultad de Medicina, Universidad de las Américas, Quito, Ecuador. [de Vries HJC] Amsterdam Institute for infection and Immunity, Infectious Diseases Program, Amsterdam, the Netherlands. Department of Infectious Diseases, Center for Sexual Health, Public Health Service, Amsterdam, the Netherlands. [Schallig HDFH] Department of Medical Microbiology and Infection Prevention, Laboratory for Experimental Parasitology, Amsterdam University Medical Centers location Academic Medical Center at the University of Amsterdam, Amsterdam, the Netherlands. Amsterdam Institute for infection and Immunity, Infectious Diseases Program, Amsterdam, the Netherlands
Vall d'Hebron Barcelona Hospital Campus
2024-01-12T08:38:00Z
2024-01-12T08:38:00Z
2023-11-29
Precisión diagnóstica; Leishmaniasis cutánea; Ecuador rural
Precisió diagnòstica; Leishmaniosi cutània; Equador rural
Diagnostic accuracy; Cutaneous leishmaniasis; Rural Ecuador
Background Clinical and laboratory diagnosis of cutaneous leishmaniasis (CL) is hampered by under-ascertainment of direct microscopy. Methods This study compared the diagnostic accuracy of qPCR on DNA extracted from filter paper to the accuracy of direct smear slide microscopy in participants presenting with a cutaneous lesion suspected of leishmaniasis to 16 rural healthcare centers in the Ecuadorian Amazon and Pacific regions, from January 2019 to June 2021. We used Bayesian latent class analysis to estimate test sensitivity, specificity, likelihood ratios (LR), and predictive values (PV) with their 95% credible intervals (95%CrI). The impact of sociodemographic and clinical characteristics on predictive values was assessed as a secondary objective. Results Of 320 initially included participants, paired valid test results were available and included in the diagnostic accuracy analysis for 129 from the Amazon and 185 from the Pacific region. We estimated sensitivity of 68% (95%CrI 49% to 82%) and 73% (95%CrI 73% to 83%) for qPCR, and 51% (95%CrI 36% to 66%) and 76% (95%CrI 65% to 86%) for microscopy in the Amazon and Pacific region, respectively. In the Amazon, with an estimated disease prevalence among participants of 73%, negative PV for qPCR was 54% (95%CrI 5% to 77%) and 44% (95%CrI 4% to 65%) for microscopy. In the Pacific, (prevalence 88%) the negative PV was 34% (95%CrI 3% to 58%) and 37% (95%CrI 3% to 63%). The addition of qPCR parallel to microscopy in the Amazon increases the observed prevalence from 38% to 64% (+26 (95%CrI 19 to 34) percentage points). Conclusion The accuracy of either qPCR on DNA extracted from filter paper or microscopy for CL diagnosis as a stand-alone test seems to be unsatisfactory and region-dependent. We recommend further studies to confirm the clinically relevant increment found in the diagnostic yield due to the addition of qPCR.
Article
Published version
English
Leishmaniosi - Diagnòstic; ADN; Microscòpia clínica; DISEASES::Parasitic Diseases::Protozoan Infections::Euglenozoa Infections::Leishmaniasis::Leishmaniasis, Cutaneous; Other subheadings::Other subheadings::/diagnosis; CHEMICALS AND DRUGS::Nucleic Acids, Nucleotides, and Nucleosides::Nucleic Acids::DNA; ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Diagnosis::Diagnostic Techniques and Procedures::Diagnostic Imaging::Microscopy; ENFERMEDADES::enfermedades parasitarias::infecciones por protozoos::infecciones por Euglenozoa::leishmaniosis::leishmaniasis cutánea; Otros calificadores::Otros calificadores::/diagnóstico; COMPUESTOS QUÍMICOS Y DROGAS::nucleótidos y nucleósidos de ácidos nucleicos::ácidos nucleicos::ADN; TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::diagnóstico::técnicas y procedimientos diagnósticos::diagnóstico por imagen::microscopía
Public Library Science
PLoS Neglected Tropical Diseases;17(11)
https://doi.org/10.1371/journal.pntd.0011745
Attribution 4.0 International
http://creativecommons.org/licenses/by/4.0/
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