Xpert MTB/RIF assay for diagnosis of pulmonary tuberculosis in children: A prospective, multi-centre evaluation
Swiss Tropical and Public Health Institute, Basel, Switzerland; University of Basel, Basel, Switzerland; Ifakara Health Institute, Bagamoyo, Tanzania; National Institute of Medical Research, Mbeya Medical Research Centre, Mbeya, Tanzania; Division of Infectious Diseases and Tropical Medicine, Medical Center of The University of Munich (LMU), Germany; German Centre for Infection Research (DZIF), Partner Site Munich, Germany; St. Francis Hospital Nsambya, AISPO, Kampala, Uganda; Emerging Bacterial Pathogens, San Raffaele Scientific Institute, Milano, Italy
Background: Following endorsement by the World Health Organisation, the Xpert MTB/RIF assay has been widely incorporated into algorithms for the diagnosis of adult tuberculosis (TB). However, data on its performance in children remain scarce. This prospective, multi-centre study evaluated the performance of Xpert MTB/RIF to diagnose pulmonary tuberculosis in children. Methods: Children older than eight weeks and younger than 16 years with suspected pulmonary tuberculosis were enrolled at three TB endemic settings in Tanzania and Uganda, and assigned to five well-defined case definition categories: culture-confirmed TB, highly probable TB, probable TB, not TB, or indeterminate. The diagnostic accuracy of Xpert MTB/RIF was assessed using culture-confirmed TB cases as reference standard. Results: In total, 451 children were enrolled. 37 (8%) had culture-confirmed TB, 48 (11%) highly probably TB and 62 probable TB (13%). The Xpert MTB/RIF assay had a sensitivity of 68% (95% CI, 50%-82%) and specificity of 100% (95% CI, 97%-100%); detecting 1.7 times more culture-confirmed cases than smear microscopy with a similar time to detection. Xpert MTB/RIF was positive in 2% (1/48) of highly probable and in 3% (2/62) of probable TB cases. Conclusions: Xpert MTB/RIF provided timely results with moderate sensitivity and excellent specificity compared to culture. Low yields in children with highly probable and probable TB remain problematic. © 2014 The British Infection Association.
adolescent; Article; child; clinical trial; diagnostic accuracy; diagnostic test accuracy study; diagnostic value; female; follow up; human; Human immunodeficiency virus infection; immunoassay; infant; lung tuberculosis; major clinical study; male; multicenter study; Mycobacterium tuberculosis; newborn; predictive value; prospective study; sensitivity and specificity; standard; Tanzania; Uganda; Xpert MTB RIF assay; adult; algorithm; evaluation study; microbiology; microscopy; polymerase chain reaction; preschool child; procedures; sputum; Tuberculosis, Pulmonary; world health organization; Adolescent; Adult; Algorithms; Child; Child, Preschool; Humans; Infant; Microscopy; Mycobacterium tuberculosis; Polymerase Chain Reaction; Prospective Studies; Sensitivity and Specificity; Sputum; Tanzania; Tuberculosis, Pulmonary; Uganda; World Health Organization