Evaluation of Xpert MTB/RIF Ultra Assay for Diagnosis of Childhood Tuberculosis: a Multicenter Accuracy Study
Lin Sun, Yu Zhu, Min Fang, Yan Shi, Xiaoshan Peng, Qiong Liao, Xinyun Wang, Shuting Quan, Yacui Wang, Liping Duan, Xiaomei Shi, Zhipeng Zhao, Lanqin Chen, Yongsheng Xu, Tongqiang Zhang, Xiaojian Cui, Chaomin Wan, Adong Shen
Abstract
A multicenter study was performed to evaluate the value of testing gastric aspirate (GA) with Xpert MTB/RIF Ultra assay (Ultra) for childhood tuberculosis (TB) detection in China. In total, 129 children with active TB and 173 children without TB were enrolled. The sensitivity of Ultra in bacteriologically confirmed TB and probable TB cases was 87.5% (42/48) and 44.4% (36/81), respectively. The specificity of Ultra was high (99.4%, 172/173). When Ultra, culture, and acid-fast bacilli outcomes were integrated as a composite reference standard, the percentage of children with definite TB increased from 37.