Diagnostic performance of two rapid tests for syphilis screening in people living with HIV in Cali, Colombia.

Autor: García Luna JA; Centro Internacional de Entrenamiento e Investigaciones Médicas - CIDEIM, Cali, Colombia.; Universidad Icesi, Cali, Colombia.; Division of Dermatology and Dermatologic Surgery, Department of Internal Medicine, School of Medicine, Universidad del Valle, Cali, Colombia., Romero-Rosas N; Centro Internacional de Entrenamiento e Investigaciones Médicas - CIDEIM, Cali, Colombia., Silva Peña SA; Centro Internacional de Entrenamiento e Investigaciones Médicas - CIDEIM, Cali, Colombia., Oviedo Sarmiento OJ; Centro Internacional de Entrenamiento e Investigaciones Médicas - CIDEIM, Cali, Colombia., Galindo Orrego X; Corporación de Lucha Contra el SIDA, Cali, Colombia., Lenis Quintero W; Clínica Recuperar IPS, Cali, Colombia., Perea LC; Clínica Recuperar IPS, Cali, Colombia., Martínez Buitrago E; Division of Infectious Diseases, Department of Internal Medicine, School of Medicine, Universidad del Valle, Cali, Colombia.; Grupo Colombiano de VIH (VIH-COL), Cali, Colombia., Osorio L; Centro Internacional de Entrenamiento e Investigaciones Médicas - CIDEIM, Cali, Colombia.; School of Public Health, Universidad del Valle, Cali, Colombia., Salazar JC; Centro Internacional de Entrenamiento e Investigaciones Médicas - CIDEIM, Cali, Colombia.; Department of Pediatrics, University of Connecticut School of Medicine, Farmington, Connecticut, United States of America.; Division of Pediatric Infectious Diseases, Connecticut Children's, Hartford, Connecticut, United States of America.; Department of Immunology, University of Connecticut School of Medicine, Farmington, Connecticut, United States of America., Smith AD; Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom., Alexander N; Centro Internacional de Entrenamiento e Investigaciones Médicas - CIDEIM, Cali, Colombia.; Universidad Icesi, Cali, Colombia.
Jazyk: angličtina
Zdroj: PloS one [PLoS One] 2023 Mar 09; Vol. 18 (3), pp. e0282492. Date of Electronic Publication: 2023 Mar 09 (Print Publication: 2023).
DOI: 10.1371/journal.pone.0282492
Abstrakt: Introduction: There is insufficient evidence supporting the use of rapid diagnostic tests (RDTs) for syphilis in people living with HIV (PLWH). We evaluated the diagnostic performance of two commercially available RDTs (Bioline and Determine) in PLWH in Cali, Colombia.
Methods: A cross-sectional field validation study on consecutive adults with confirmed HIV diagnosis attending three outpatient clinics. Both RDTs were performed on capillary blood (CB), obtained by finger prick, and sera, by venipuncture. A combination of treponemal enzyme linked immunosorbent assay (ELISA) and Treponema pallidum haemagglutination assay (TPHA) on serum samples was the reference standard. Rapid plasma reagin (RPR) and clinical criteria were added to define active syphilis. Sensitivity and specificity, predictive values and likelihood ratios (LR) of RDTs were estimated with their corresponding 95% confidence interval (95% CI). Stratified analyses by sample type, patient characteristics, non-treponemal titers, operator and re-training were performed.
Results: 244 PLWH were enrolled, of whom 112 (46%) had positive treponemal reference tests and 26/234 (11.1%) had active syphilis. The sensitivities of Bioline on CB and sera were similar (96.4% vs 94.6%, p = 0.6). In contrast, Determine had a lower sensitivity on CB than sera (87.5% vs 99.1%, p<0.001). Sensitivities were lower in PLWH not receiving ART (Bioline 87.1% and Determine 64.5%, p<0.001) and for one of the operators (Bioline 85% and Determine 60%, p<0.001). Specificities of the RDTs were > 95% in most analyses. Predictive values were 90% or higher. For active syphilis, the RDTs showed a similar performance pattern but with decreased specificities.
Conclusion: The studied RDTs have an excellent performance in PLWH to screen for syphilis and potentially for active syphilis, yet Determine performs better on sera than CB. Patient characteristics and potential difficulties operators may face in acquiring enough blood volume from finger pricks should be considered for the implementation and the interpretation of RDTs.
Competing Interests: The authors have declared that no competing interest exist.
(Copyright: © 2023 García Luna et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)
Databáze: MEDLINE
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