Abstract

BackgroundQuick diagnosis of smear-negative pulmonary tuberculosis (TB) and extra-pulmonary TB are urgently needed in clinical diagnosis. Our research aims to investigate the usefulness of the interferon-γ release assay (IGRA) for the diagnosis of smear-negative pulmonary and extra-pulmonary TB.MethodsWe performed TB antibody and TB-IGRA tests on 389 pulmonary TB patients (including 120 smear-positive pulmonary TB patients and 269 smear-negative pulmonary TB patients), 113 extra-pulmonary TB patients, 81 patients with other pulmonary diseases and 100 healthy controls. Blood samples for the TB-Ab test and the TB-IGRA were collected, processed, and interpreted according to the manufacturer’s protocol.ResultsThe detection ratio of smear-positive pulmonary TB patients and smear-negative pulmonary TB patients were 90.8% (109 of 120) and 89.6% (241 of 269), respectively. There was no statistically significant difference of its performance between these two sample sets (P > 0.05). The detection ratio of positive TB patients and extra-pulmonary TB patients were 90.0% (350 of 389) and 87.6% (99 of 113), respectively, which was not significantly different (P > 0.05).ConclusionsIn this work, the total detection ratio using TB-IGRA was 89.4%, therefore TB-IGRA has diagnostic values in smear-negative pulmonary TB and extra-pulmonary TB diagnosis.

Highlights

  • Quick diagnosis of smear-negative pulmonary tuberculosis (TB) and extra-pulmonary TB are urgently needed in clinical diagnosis

  • Whole blood samples of 502 patients with TB were collected from Hangzhou Red Cross Hospital, Quzhou People’s Hospital, and Hospital of integrated traditional Chinese and Western medicine in Xiacheng District of Hangzhou and the Center for Disease Control and Prevention (CDC) of Zhejiang Province of China between September 2012 and June 2013

  • TB-Interferon-γ release assay (IGRA) test results of different patient groups The total detection ratio of TB-IGRA tests for all groups combined was 89.4% (449 of 502), while the detection ratios of the TB group and extrapulmonary TB group were 90.0% (350 of 389) and 87.6% (99 of 113), respectively

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Summary

Introduction

Quick diagnosis of smear-negative pulmonary tuberculosis (TB) and extra-pulmonary TB are urgently needed in clinical diagnosis. Our research aims to investigate the usefulness of the interferon-γ release assay (IGRA) for the diagnosis of smear-negative pulmonary and extra-pulmonary TB. Ji et al Infectious Diseases of Poverty (2017) 6:121 hard to detect M. tuberculosis in patient’s sputum. It results in a delay in the diagnostic process for pulmonary TB, especially in smearnegative cases [4]. The interferon-γ release assay (IGRA) uses a special antigen as stimulus and follows Enzyme Linked Immunosorbent Assay (ELISA) procedures for detection has potentially high specificity and sensitivity. After being invented by Lalvani [5], this method is widely used in many counties and has become the most commonly used diagnostic method in TB detection [7,8,9,10]

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