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Use of Xpert MTB/RIF Assay in Rural Health Facilities in Southern Ethiopia

José M Ramos, María Fernández-Muñoz, Gabriel Tisiano, Haji Fano, Tafese Yohannes, Ashenafi Gosa, Abraham Tesfamariam, Cristina Verdu-Expositvo, Juan Romanyk, Francisco Reyes and Miguel Gorgolas

Background: Tuberculosis (TB) is the leading cause of morbidity and mortality in Ethiopia. We describe the performance of the Xpert-MTB/RIF assay for presumptive TB in health facilities that refer samples to a regional reference laboratory.
Methods: A cross-sectional study was conducted in patients with presumptive TB from 1st April 2015 to 30th August 2016. The study was performed in Gambo Hospital, Ethiopia. The samples sent to the referral laboratory were analyzed according to national protocols on the diagnosis of TB and multidrug resistant-TB in children with presumptive TB.
Results: We studied one sample each from 309 unique patients; 197 (63.8%) were less than 14 years old, and 165 (53.4%) were male. The most commonly analyzed sample was gastric aspiration (n=144, 46.6%) followed by sputum (n=92, 29.8%). Gastric aspiration was performed mainly in children (98.6%, 142/144; p<0.001), while peritoneal effusion (94.4%, 17/18; p<0.001), pleural effusion (80.8%, 21/26; p<0.001), lymph node (63.6%, 14/22; p=0.01), and sputum (56/92, 60.9%; p<0.001) were performed mainly in adults. For 10 samples, the results were not available from the referral laboratory. The samples were positive for TB by Xpert MTB/RIF in 22.4% (67/299) of the samples. Only one sample was resistant to rifampicin (0.3%). The results of Xpert MTB/RIF were positive in 76.2% (16/21) of the lymph node samples (p<0.001), 22.3% of the gastric aspiration samples, 20.0% (31/139) of the sputum samples, 1.5% (1/17) of the ascites fluid samples, and 0.0% (0/25) of the pleural effusions (p=0.002).
Conclusion: Xpert MTB/RIF facilitates the diagnosis of TB, with microbiological confirmation, in up to 20% of the samples.