Validación e implementación de GeneXpert MTB/RIF para diagnóstico de tuberculosis en Ecuador

• Main Authors: Ortiz-Jiménez, José Marcelo, Franco-Sotomayor Greta, Ramos-Ramírez Martha
• Format: Article in Journal/Newspaper
• Language: English; Spanish
• Published: Universidad del Zulia,Facultad de Medicina,Departamento de Enfermedades Infecciosas y Tropicales 2019
• Subjects: Validation studies; sputum; sensitivity; specificity; rifampin; Estudios de validación; esputo; sensibilidad; especificidad; rifampicina; Mycobacterium tuberculosis; Arctic medicine. Tropical medicine; RC955-962; Public aspects of medicine; RA1-1270; Arctic; Guayaquil; Referencia; Rif
• Online Access: https://doaj.org/article/b71c05a5d85642b6a72f2f209b34d12d

Abstract: The objective of the study was the validation and implementation of GeneXpert MTB/RIF for routine use in the rapid detection of tuberculosis and sensitivity to rifampicin in clinical samples; for this, 1592 respiratory samples were collected and analyzed in the laboratory of Instituto Nacional de Investigación en Salud Pública Guayaquil. The analysis of the results of GeneXpert in comparison with smear microscopy showed an initial sensitivity of 99.8% and specificity of 93.2%; The analysis of discrepancies using the results of the culture as a reference method showed that the GeneXpert results considered false negatives turned out to be true negatives, the same happens with the false positives that correspond to true positives. Recalculated the sensitivity and specificity of the Xpert was 99.8% and 100% correspondingly. The comparison with the drugs susceptibility test showed a sensitivity of 91.4% and a specificity of 95.5% for the GeneXpert MTB/RIF system. It is concluded that the implementation of the Xpert system allows solution to certain problems associated with the application of conventional diagnostic methodologies, decreasing the waiting times, and increasing the sensitivity and specificity in the diagnosis of drug-resistant tuberculosis, thus generating a valuable opportunity for early diagnosis. Resumen: El objetivo del estudio fue la validación e implementación de GeneXpert MTB/RIF para uso rutinario en la detección rápida de tuberculosis, y sensibilidad a la rifampicina en muestras clínicas; para esto se recogieron 1592 muestras respiratorias y fueron analizadas en el laboratorio del Instituto Nacional de Investigación en Salud Pública Guayaquil. El análisis de los resultados de GeneXpert en comparación con la baciloscopía mostraron una sensibilidad inicial de 99,8% y especificidad de 93,2%; el análisis de discrepancias utilizando los resultados del cultivo como método de referencia mostró que los resultados de GeneXpert considerados falsos negativos resultaron ser verdaderos negativos, ...