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Multicenter Study
. 2020 Aug 24;58(9):e00702-20.
doi: 10.1128/JCM.00702-20. Print 2020 Aug 24.

Evaluation of Xpert MTB/RIF Ultra Assay for Diagnosis of Childhood Tuberculosis: a Multicenter Accuracy Study

Lin Sun #  1 , Yu Zhu #  2 , Min Fang #  3 , Yan Shi  3 , Xiaoshan Peng  2 , Qiong Liao  2 , Xingyun Wang  1 , Shuting Quan  1 , Yacui Wang  1 , Li Duan  3 , Xiaomei Shi  3 , Zhipeng Zhao  1 , Lanqin Chen  1 , Yongsheng Xu  4 , Tongqiang Zhang  4 , Xiaojian Cui  4 , Chaomin Wan  5 , Adong Shen  6
Affiliations
Multicenter Study

Evaluation of Xpert MTB/RIF Ultra Assay for Diagnosis of Childhood Tuberculosis: a Multicenter Accuracy Study

Lin Sun et al. J Clin Microbiol. .

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 37.2% (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.

Keywords: child; diagnosis; gastric aspirate; tuberculosis.

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Figures

FIG 1
FIG 1
Flow chart of the study population.
FIG 2
FIG 2
Venn diagram of the different diagnostic test results for childhood tuberculosis using gastric aspirate samples.
See this image and copyright information in PMC

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