Evaluación de una prueba de biología molecular para la identificación de Mycobacterium tuberculosis y sensibilidad a medicamentos de primera y segunda línea en un hospital de alta complejidad

Abstract

Objective: To evaluate the utility of Anyplex™II_MTB/MDR/XDR for detection of Mycobacterium tuberculosis and drug susceptibility testing to first and second line, and the impact on the therapeutic approach, in patients with suspected pulmonary tuberculosis at a reference hospital. Medellin, 2014-2015. Material and Methods: this is a retrospective, descriptive, observational study in patients that during its hospitalization were studied by: ZN-smear, Ogawa-Kudoh culture, Anyplex™II_MTB/MDR/XDR assay and had an adequate record of medical history. Univariate descriptive statistics was performed and accuracy of the test was analyzed. Results: 156 samples of 154 patients were included, 65.6[%] were men. The most frequent diagnosis of admission was the Human Immunodeficiency Virus (46.1[%]). Sensitivity and specificity was 96.36[%] (95[%] CI 90.51 to 100) and 90.51[%] (95[%] CI 83.62 to 96.38) respectively. Some type of resistance was found in 12.6[%] of cases. 57[%] of the results were taken into account to make treatment decisions. Discussion: The sensitivity was higher than regarding in previous studies were obtained, comparing with cultures available at institution. Among limitations, this study was retrospective and the unavailability liquid culture medium (MIGIT). Conclusions: Anyplex™II_MTB/MDR/XDR was useful in the identification of mycobacteria and drug susceptibility in direct sample. The result influenced therapeutic decisions in more than half of patients with positive result. The implementation of new diagnostic aids must be in accordance with the needs in patient care.