Risk factors for negative T-SPOT.TB assay results in patients with confirmed active tuberculosis: A retrospective study

Introduction: The interferon-γ release assays as potent adjunct tools for the quick detection of TB in high burden countries is feasible. In this retrospective study, we aimed to identify the risk factors for negative T-SPOT results in confirmed active tuberculosis. Methodology: We consecutively...

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Main Authors: Yanwan Shangguan, Hong Fang, Shuting Wang, Zhongkang Ji, Pei Shi, Xuewen Feng, Kaijin Xu
Format: Article
Language:English
Published: The Journal of Infection in Developing Countries 2020-11-01
Series:Journal of Infection in Developing Countries
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Online Access:https://jidc.org/index.php/journal/article/view/12063
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author Yanwan Shangguan
Hong Fang
Shuting Wang
Zhongkang Ji
Pei Shi
Xuewen Feng
Kaijin Xu
author_facet Yanwan Shangguan
Hong Fang
Shuting Wang
Zhongkang Ji
Pei Shi
Xuewen Feng
Kaijin Xu
author_sort Yanwan Shangguan
collection DOAJ
description Introduction: The interferon-γ release assays as potent adjunct tools for the quick detection of TB in high burden countries is feasible. In this retrospective study, we aimed to identify the risk factors for negative T-SPOT results in confirmed active tuberculosis. Methodology: We consecutively enrolled 1,021 patients who were positive for acid-fast bacilli smear staining or culture-confirmed mycobacterial infection and simultaneously tested with the T-SPOT.TB assay. All of the included specimens were used to discriminate the Mycobacterium species using the biochip assay. We collected basic clinical characteristics and laboratory results for further analysis. Results: Of the 1,021 patients enrolled in the study, 89 patients were identified as having nontuberculous mycobacteria (NTM). Ninety-nine patients were excluded from the analysis because of indeterminate T-SPOT.TB results, while the remaining 833 patients were identified as having Mycobacterium tuberculosis infection. In total, 159 patients had false-negative T-SPOT.TB results (19.1% of 833). The concordance rate between the T-SPOT.TB results and final diagnoses in females was always lower than that in males. Multivariate logistic regression analysis showed that female sex (OR 1.81; 95% CI 1.19, 2.7; p = 0.006), age (OR 1.02; 95% CI 1.01, 1.03; p = 0.003), acid-fast bacilli (AFB) smear-negative (OR 5.45; 95% CI 3.62, 8.19; p < 0.001), HIV coinfection (OR 6.83; 95% CI 2.73, 17.10; p < 0.001) were associated with negative T-SPOT.TB result. Conclusions: Female is another independent risk factor of negative T-SPOT.TB results, besides to elder, HIV co-infection, acid-fast bacilli (AFB) smear-negative who are suspected of having active TB infection.
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spelling doaj-art-7dd207fe8029406798e11041fbed344d2025-08-20T02:57:25ZengThe Journal of Infection in Developing CountriesJournal of Infection in Developing Countries1972-26802020-11-01141110.3855/jidc.12063Risk factors for negative T-SPOT.TB assay results in patients with confirmed active tuberculosis: A retrospective studyYanwan Shangguan0Hong Fang1Shuting Wang2Zhongkang Ji3Pei Shi4Xuewen Feng5Kaijin Xu6State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, Zhejiang University School of Medicine, Zhejiang, ChinaState Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, Zhejiang University School of Medicine, Zhejiang, ChinaState Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, Zhejiang University School of Medicine, Zhejiang, ChinaState Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, Zhejiang University School of Medicine, Zhejiang, ChinaState Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, Zhejiang University School of Medicine, Zhejiang, ChinaState Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, Zhejiang University School of Medicine, Zhejiang, ChinaState Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, Zhejiang University School of Medicine, Zhejiang, China Introduction: The interferon-γ release assays as potent adjunct tools for the quick detection of TB in high burden countries is feasible. In this retrospective study, we aimed to identify the risk factors for negative T-SPOT results in confirmed active tuberculosis. Methodology: We consecutively enrolled 1,021 patients who were positive for acid-fast bacilli smear staining or culture-confirmed mycobacterial infection and simultaneously tested with the T-SPOT.TB assay. All of the included specimens were used to discriminate the Mycobacterium species using the biochip assay. We collected basic clinical characteristics and laboratory results for further analysis. Results: Of the 1,021 patients enrolled in the study, 89 patients were identified as having nontuberculous mycobacteria (NTM). Ninety-nine patients were excluded from the analysis because of indeterminate T-SPOT.TB results, while the remaining 833 patients were identified as having Mycobacterium tuberculosis infection. In total, 159 patients had false-negative T-SPOT.TB results (19.1% of 833). The concordance rate between the T-SPOT.TB results and final diagnoses in females was always lower than that in males. Multivariate logistic regression analysis showed that female sex (OR 1.81; 95% CI 1.19, 2.7; p = 0.006), age (OR 1.02; 95% CI 1.01, 1.03; p = 0.003), acid-fast bacilli (AFB) smear-negative (OR 5.45; 95% CI 3.62, 8.19; p < 0.001), HIV coinfection (OR 6.83; 95% CI 2.73, 17.10; p < 0.001) were associated with negative T-SPOT.TB result. Conclusions: Female is another independent risk factor of negative T-SPOT.TB results, besides to elder, HIV co-infection, acid-fast bacilli (AFB) smear-negative who are suspected of having active TB infection. https://jidc.org/index.php/journal/article/view/12063Active tuberculosisIGRAsTB assayT-SPOTT-SPOT.TB assay
spellingShingle Yanwan Shangguan
Hong Fang
Shuting Wang
Zhongkang Ji
Pei Shi
Xuewen Feng
Kaijin Xu
Risk factors for negative T-SPOT.TB assay results in patients with confirmed active tuberculosis: A retrospective study
Journal of Infection in Developing Countries
Active tuberculosis
IGRAs
TB assay
T-SPOT
T-SPOT.TB assay
title Risk factors for negative T-SPOT.TB assay results in patients with confirmed active tuberculosis: A retrospective study
title_full Risk factors for negative T-SPOT.TB assay results in patients with confirmed active tuberculosis: A retrospective study
title_fullStr Risk factors for negative T-SPOT.TB assay results in patients with confirmed active tuberculosis: A retrospective study
title_full_unstemmed Risk factors for negative T-SPOT.TB assay results in patients with confirmed active tuberculosis: A retrospective study
title_short Risk factors for negative T-SPOT.TB assay results in patients with confirmed active tuberculosis: A retrospective study
title_sort risk factors for negative t spot tb assay results in patients with confirmed active tuberculosis a retrospective study
topic Active tuberculosis
IGRAs
TB assay
T-SPOT
T-SPOT.TB assay
url https://jidc.org/index.php/journal/article/view/12063
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