Open AccessEvaluation of Xpert MTB/RIF Ultra Assay for Diagnosis of Childhood Tuberculosis: a Multicenter Accuracy Study
Author(s) -
Lin Sun,
Yu Zhu,
Min Fang,
Yan Shi,
Xiaoshan Peng,
Qiong Liao,
Xinyun Wang,
Shuting Quan,
Yacui Wang,
Lingxun Duan,
Xiongwei Shi,
Zhipeng Zhao,
Lanqing Chen,
Yongsheng Xu,
Tongqiang Zhang,
Xiaohui Cui,
Chaomin Wan,
Adong Shen
Publication year - 2020
Publication title -
journal of clinical microbiology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.349
H-Index - 255
eISSN - 1070-633X
pISSN - 0095-1137
DOI - 10.1128/jcm.00702-20
Subject(s) - medicine , tuberculosis , multicenter study , mycobacterium tuberculosis , bacilli , gastroenterology , pathology , bacteria , randomized controlled trial , biology , genetics
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 37.2% (48/129) to 67.4% (87/129). The sensitivity of Ultra is 80.0% (40/50) in children aged <4 years, which is significantly higher than that in older children (48.1%, 38/79) ( P < 0.001). Ultra conducted using GA samples can provide faster results, allowing an early and accurate TB diagnosis, especially in younger children with difficulty producing sputum.