Performance of Xpert/MTB/RIF assay for childhood pulmonary tuberculosis among HIV negative children with real world evidence in China

Lu Xia; Xuhui Liu; Xueqin Qian; Tao Li; Xiuhong Xi; Xiaoyong Fan; Ping Liu; Shuihua Lu

doi:10.1016/j.jiph.2020.08.006

Performance of Xpert/MTB/RIF assay for childhood pulmonary tuberculosis among HIV negative children with real world evidence in China

J Infect Public Health. 2020 Nov;13(11):1762-1767. doi: 10.1016/j.jiph.2020.08.006. Epub 2020 Sep 6.

Authors

Lu Xia¹, Xuhui Liu², Xueqin Qian², Tao Li², Xiuhong Xi², Xiaoyong Fan², Ping Liu³, Shuihua Lu⁴

Affiliations

¹ Shanghai Public Health Clinical Center, Fudan University, Shanghai, China; Interdisciplinary Science Research Institute of Shanghai University of Traditional Chinese Medicine, Shanghai, China.
² Shanghai Public Health Clinical Center, Fudan University, Shanghai, China.
³ Interdisciplinary Science Research Institute of Shanghai University of Traditional Chinese Medicine, Shanghai, China.
⁴ Shanghai Public Health Clinical Center, Fudan University, Shanghai, China. Electronic address: tubercle@shphc.org.cn.

PMID: 32900665
DOI: 10.1016/j.jiph.2020.08.006

Abstract

Background: Rapid and accurate notification of childhood pulmonary tuberculosis (PTB) is a worldwide challenge. Although the Xpert MTB/RIF assay (Xpert) has been endorsed as the initial test for suspected PTB in many countries, limited studies have reported the performance of Xpert in childhood PTB. The aim of this study is to evaluate the real-world performance of Xpert for the detection of childhood PTB among HIV negative children in China.

Methods: We consecutively extracted the data of all patients ≤14 years with pulmonary disease through the electronic medical record (EMR) systems of Shanghai Public Health Clinical Center from January 2014 to December 2017. The clinical profile, the decision-making tests including AFB smear, solid/liquid culture, pathological examination and Xpert result were matched and assessed. The real diagnostic accuracy and the all-factors case notification rate for childhood PTB with the implementation of Xpert were evaluated.

Results: 519 HIV negative cases ≤14 years with pulmonary disease were extracted from the data base. Of these, 145 had matched results, there were 374 non-matched cases including 346 with incomplete or unavailable data and 28 with NTM, BCG or an unidentified strain. For matched data, the overall sensitivity and specificity of the Xpert assay were 66.7% (32/48, 95%CI 0.52-0.80) and 87.6% (85/97, 95%CI 0.87-0.98) respectively against the gold standard; 34.6% (44/127, 95%CI 26.6-43.7) and 100% against the composite clinical reference standard (CCRS). The all-factors case notification rate by Xpert was 29%.

Conclusion: Xpert/MTB RIF assay has acceptable sensitivity and excellent specificity for rapid diagnosis of children with pulmonary TB as well as for the detection of RIF resistance in China. However, implementation of Xpert for the initial diagnosis of childhood PTB is inadequate to meet the urgent requirement for rapid and accurate detection of childhood PTB.

Keywords: Childhood; Diagnosis; Pulmonary tuberculosis; Xpert/MTB RIF assay.

MeSH terms

Adolescent
Child
Child, Preschool
China / epidemiology
Female
HIV Infections* / diagnosis
Humans
Male
Mycobacterium tuberculosis* / genetics
Rifampin
Sensitivity and Specificity
Sputum
Tuberculosis, Pulmonary* / diagnosis
Tuberculosis, Pulmonary* / epidemiology

Substances

Rifampin