Abstract

At present, tuberculosis remains a serious threat to human health. The diagnosis of pulmonary tuberculosis (PTB) is still difficult, and the prominent challenge for diagnosis is the lack of a highly sensitive and specific method. In order to explore the diagnostic value of parallel tests, this study prospectively enrolled 258 patients with smear-negative PTB from May 2, 2015 to December 31, 2016. The sputum specimens and bronchial alveolar lavage fluid (BALF) samples from all patients were assessed for MTB detection by culture, Xpert MTB/RIF, and simultaneous amplification and testing method for TB (SAT-TB). Overall, the sensitivity of any single test using culture, Xpert MTB/RIF, or SAT-TB was lower than that for parallel tests (p < 0.05), and the sensitivity rates for MTB detection in BALF were significantly higher than those in sputum samples. There were lower agreements in the detection results between sputum samples and BALF for all tests (p < 0.05). The parallel tests models of using culture plus Xpert MTB/RIF plus SAT-TB, culture plus Xpert, or culture plus SAT-TB achieved higher sensitivities compared with all three single test models (p < 0.05). Additionally, joint detection using sputum and BALF samples achieved a high sensitivity (0.8566, 95% CI: 0.8086–0.8941). In conclusion, the parallel tests model using culture, Xpert MTB/RIF, and SAT-TB in sputum plus BALF significantly increases the diagnostic performance of smear-negative PTB; thus, this method should be applied clinically when PTB is suspected but smear results are negative.

Highlights

  • Tuberculosis (TB) remains one of the leading infectious diseases in the world and is a serious detriment to public health

  • Xpert MTB/RIF is a molecular method for the detection of Mycobacterium tuberculosis (MTB) that has excellent diagnostic efficacy in terms of assay-time and positive detection rate, and it has been approved by the WHO (Steingart et al, 2013, 2014)

  • Three methods were applied to testing the sputum and bronchial alveolar lavage fluid (BALF) samples from the 258 included patients with confirmed pulmonary tuberculosis (PTB)

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Summary

Introduction

Tuberculosis (TB) remains one of the leading infectious diseases in the world and is a serious detriment to public health. Parallel Tests for PTB in 2000) in 2016, as well as an additional 374,000 deaths among HIV-positive people that year (World Health Organization [WHO], 2017). Xpert MTB/RIF yielded high diagnostic specificity for pulmonary tuberculosis (PTB) (Penz et al, 2015; Kaur et al, 2016; Sehgal et al, 2016; Hasan et al, 2017; Li et al, 2017; Lombardi et al, 2017; Rufai et al, 2017). Xpert MTB/RIF provides high efficacy MTB detection in bronchial alveolar lavage fluid (BALF) and non-respiratory samples, such as body fluid, fine needle aspiration, and different tissues, and it presents useful diagnostic value for extrapulmonary TB (Barnard et al, 2012; Penz et al, 2015; Sehgal et al, 2016; Rufai et al, 2017)

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