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      Cobertura y fidelidad de la prueba Xpert MTB/RIF™ en un área de alta carga de tuberculosis pulmonar en Colombia Translated title: Coverage and fidelity of the Xpert MTB/RIF™ implementation in a high-burden area for pulmonary tuberculosis in Colombia

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          Resumen

          Introducción.

          La prueba Xpert MTB/RIF™ es una prueba molecular rápida para el diagnóstico de la tuberculosis y la resistencia a la rifampicina. Desde el 2010 es la recomendada por la Organización Mundial de la Salud (OMS) y, aunque fue introducida en Colombia en el 2012, se desconocen los resultados de su uso.

          Objetivo.

          Describir la cobertura y la fidelidad en el uso de la prueba Xpert MTB/RIF™ en pacientes con tuberculosis pulmonar en una ciudad con alta carga de la enfermedad en Colombia.

          Materiales y métodos.

          Se hizo un estudio retrospectivo descriptivo de casos del programa de tuberculosis en Cali entre el 2013 y el 2019. La cobertura se estimó como el total de pruebas empleadas en los casos registrados en el programa. La fidelidad se midió con base en los protocolos internacionales de uso de la Xpert MTB/RIF™. Además, se hizo un análisis de correspondencias múltiples entre la prueba y las variables sociodemográficas.

          Resultados.

          Se incluyeron 6.328 pacientes con tuberculosis pulmonar, de los cuales 181 eran resistentes a los fármacos. La cobertura total de la Xpert MTB/RIF™ durante el periodo de estudio fue de 10,3 % (n=655), con una variación anual entre 0,2 y 23 %. La fidelidad fue de 46,8 % para los grupos de mayor riesgo de tuberculosis multirresistente (TB-MDR). El uso de la prueba se relacionó con la condición de ser hombre, afrocolombiano, y tener entre 41 y 60 años de edad.

          Conclusiones.

          La cobertura de la prueba Xpert MTB/RIF™ en Cali es baja y su uso no responde a la priorización recomendada para su implementación. Se requieren estrategias para promover su uso adecuado, de manera que contribuya a la meta de poner fin a la tuberculosis.

          Abstract

          Introduction:

          The Xpert MTB/RIF™ is a rapid molecular test that diagnoses tuberculosis and rifampin resistance. Since 2010, it is recommended by the World Health Organization (WHO) and although it was introduced in Colombia since 2012, the results of its implementation are unknown.

          Objective:

          To describe the coverage and fidelity in the implementation of the Xpert MTB/ RIF™ in patients with pulmonary tuberculosis in a city with a high burden for the disease in Colombia.

          Materials and methods:

          We conducted a retrospective, descriptive study of cases from a tuberculosis program in Cali between 2013 and 2019. We estimated the coverage as the total number of tests used compared to the cases registered in the program and the fidelity based on international Xpert MTB/RIF™ implementation protocols. We performed a multivariate analysis of multiple correspondences between the test and the sociodemographic variables.

          Results:

          We included 6,328 patients with pulmonary tuberculosis of whom 181 were drug-resistant. The Xpert MTB/RIF™ coverage was 10,3% (n=655) with an annual variation between 0.2% and 23%. Loyalty among the highest risk groups of MDR-TB was 46.8%. The use of the test was related to being an Afro-Colombian man between 41 and 60 years of age.

          Conclusions:

          The coverage of the Xpert MTB/RIF in Cali is low and its use does not follow the recommended prioritization for its implementation. Implementation strategies are required for its proper use to contribute to the goal of ending tuberculosis.

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          Most cited references64

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          Outcomes for Implementation Research: Conceptual Distinctions, Measurement Challenges, and Research Agenda

          An unresolved issue in the field of implementation research is how to conceptualize and evaluate successful implementation. This paper advances the concept of “implementation outcomes” distinct from service system and clinical treatment outcomes. This paper proposes a heuristic, working “taxonomy” of eight conceptually distinct implementation outcomes—acceptability, adoption, appropriateness, feasibility, fidelity, implementation cost, penetration, and sustainability—along with their nominal definitions. We propose a two-pronged agenda for research on implementation outcomes. Conceptualizing and measuring implementation outcomes will advance understanding of implementation processes, enhance efficiency in implementation research, and pave the way for studies of the comparative effectiveness of implementation strategies.
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            Implementation fidelity in community-based interventions.

            Implementation fidelity is the degree to which an intervention is delivered as intended and is critical to successful translation of evidence-based interventions into practice. Diminished fidelity may be why interventions that work well in highly controlled trials may fail to yield the same outcomes when applied in real life contexts. The purpose of this paper is to define implementation fidelity and describe its importance for the larger science of implementation, discuss data collection methods and current efforts in measuring implementation fidelity in community-based prevention interventions, and present future research directions for measuring implementation fidelity that will advance implementation science. (c) 2010 Wiley Periodicals, Inc.
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              The New Xpert MTB/RIF Ultra: Improving Detection of Mycobacterium tuberculosis and Resistance to Rifampin in an Assay Suitable for Point-of-Care Testing

              ABSTRACT The Xpert MTB/RIF assay (Xpert) is a rapid test for tuberculosis (TB) and rifampin resistance (RIF-R) suitable for point-of-care testing. However, it has decreased sensitivity in smear-negative sputum, and false identification of RIF-R occasionally occurs. We developed the Xpert MTB/RIF Ultra assay (Ultra) to improve performance. Ultra and Xpert limits of detection (LOD), dynamic ranges, and RIF-R rpoB mutation detection were tested on Mycobacterium tuberculosis DNA or sputum samples spiked with known numbers of M. tuberculosis H37Rv or Mycobacterium bovis BCG CFU. Frozen and prospectively collected clinical samples from patients suspected of having TB, with and without culture-confirmed TB, were also tested. For M. tuberculosis H37Rv, the LOD was 15.6 CFU/ml of sputum for Ultra versus 112.6 CFU/ml of sputum for Xpert, and for M. bovis BCG, it was 143.4 CFU/ml of sputum for Ultra versus 344 CFU/ml of sputum for Xpert. Ultra resulted in no false-positive RIF-R specimens, while Xpert resulted in two false-positive RIF-R specimens. All RIF-R-associated M. tuberculosis rpoB mutations tested were identified by Ultra. Testing on clinical sputum samples, Ultra versus Xpert, resulted in an overall sensitivity of 87.5% (95% confidence interval [CI], 82.1, 91.7) versus 81.0% (95% CI, 74.9, 86.2) and a sensitivity on sputum smear-negative samples of 78.9% (95% CI, 70.0, 86.1) versus 66.1% (95% CI, 56.4, 74.9). Both tests had a specificity of 98.7% (95% CI, 93.0, 100), and both had comparable accuracies for detection of RIF-R in these samples. Ultra should significantly improve TB detection, especially in patients with paucibacillary disease, and may provide more-reliable RIF-R detection.
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                Author and article information

                Journal
                Biomedica
                Biomedica
                bio
                Biomédica
                Instituto Nacional de Salud
                0120-4157
                2590-7379
                10 December 2020
                Oct-Dec 2020
                : 40
                : 4
                : 626-640
                Affiliations
                [1 ] original Secretaría de Salud Municipal de Santiago de Cali, Cali, Colombia orgnameSecretaría de Salud Municipal de Santiago de Cali Cali, Colombia
                [2 ] original Doctorado en Salud, Universidad del Valle, Cali, Colombia normalizedUniversidad del Valle orgnameUniversidad del Valle Cali, Colombia
                [3 ] original Grupo de Epidemiología y Salud Poblacional, Escuela de Salud Pública, Universidad del Valle, Cali, Colombia normalizedUniversidad del Valle orgnameUniversidad del Valle Cali, Colombia
                Author notes
                [* ] Correspondencia: Freddy Agredo, Secretaría de Salud Pública Municipal de Cali, Calle 4B N° 36-00, Cali, Colombia Teléfono: (572) 556 0562 y 554 2522; fax: (572) 558 7686 freddy.agredo@ 123456correounivalle.edu.co
                Article
                10.7705/biomedica.5272
                7808780
                33275342
                3b8696ce-cc27-467c-bb8a-005cbaf9a56f

                Este es un artículo publicado en acceso abierto bajo una licencia Creative Commons

                History
                : 12 November 2019
                : 15 May 2020
                Page count
                Figures: 3, Tables: 3, Equations: 0, References: 41, Pages: 15
                Categories
                Artículo Original

                tuberculosis pulmonar,técnicas de diagnóstico molecular,rifampicina,resistencia a medicamentos,tuberculosis, pulmonary,molecular diagnostic techniques, rifampin,drug resistance

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