Evaluation of GeneXpert® in Brazil Through a Historical and Epidemiological Approach

Abstract Background: The Rapid Molecular Test (RMT) Gene Xpert is widely used as a control strategies and surveillance for tuberculosis (TB). In the region of the Americas TB incidence is slowly increasing, owing to an upward trend in Brazil, which is among the high TB burden countries (HBCs) ranking the 19th position. In this context, we aimed to: (i) describe the implementation and history of RMT-TB (Xpert® MTB/RIF and Xpert® MTB/RIF Ultra) in Brazil; (ii) to evaluate the national RMT-laboratory distribution and TB and RIF detection by RMT-TB equipment (by year, by federal units and by region); and (iii) to correlate these data the Brazilian TB incidence. Methods: For this, we collected the quantitative data of Xpert® MTB/RIF and Xpert® MTB/RIF Ultra assays, performed in the pulmonary TB investigation from 2014 to 2020, provided by the Brazilian Ministry of Health. A spatial visualization using ArcGIS software was performed. Results: The Southeast region allocated about double RMT-laboratories from 39.4% - 45.9% of the total value over five which is the number of regions. Regarding the federal units, the São Paulo state allocated alone from 20.2% to 34.1% (5.0 to 8.5 times the value) of RMT-laboratories depending on the year observed. There were significant differences (p < 0.0001) in the frequency of RMT-laboratory in all years of the historical series. There was an unequal distribution of RMT-laboratory between Brazilian regions and federal units. Conclusions: This alerts for the surveillance of rapid molecular detection of TB in different parts of the country, with the possibility of improving the distribution of tests in areas of higher incidence to achieve the disease control recommended by national and worldwide authorities.