Interferon-Gamma Release Assay is Not Appropriate for the Diagnosis of Active Tuberculosis in High-Burden Tuberculosis Settings

Kang, Wanli; Wang, Guirong; M, Wu; Yang, Kunyun; Ertai, A; Wu, Shucai; Geng, Shujun; Li, Zhihui; Li, Mingwu; Li, Liang; Tang, Shenjie

doi:10.4103/0366-6999.223860

Cited by 16 publications

(14 citation statements)

References 28 publications

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“…The false positives of IGRA are common in this survey (false positives rate, i.e., FPR was 46.5%), which is consistent with previous research in China (FPR was 43.6%) [22], mainly because China is a country with high burden of TB, and the prevalence of latent TB is as high as 44.5% [23]; in addition, for patients with previous TB, there may be a long-term presence of antigen-specific memory T cells in the body, resulting in false positive results [24]. Thus, IGRA was not suggested to be used alone for the diagnosis of active PTB in high-burden TB settings.…”

Section: Discussionsupporting

confidence: 92%

A retrospective study on Xpert MTB/RIF for detection of tuberculosis in a teaching hospital in China

Lin

Zhang

et al. 2020

BMC Infect Dis

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Background: The Xpert MTB/RIF assay is an automated molecular test that is designed to simultaneously detect Mycobacterium tuberculosis (MTB) complex and rifampin resistance. However, there are relatively few studies on this method in China. Xpert has been routinely used at Peking University People's Hospital (PKUPH) since November 2016. Thus, the aim of this study was to evaluate the performance of Xpert, and provide a reference and guidance for the detection and diagnosis of TB in non-TB specialized hospitals. Methods: The medical records of inpatients simultaneously tested with Xpert, acid-fast bacilli (AFB) smear microscopy, and interferon-gamma release assay (IGRA, by T-SPOT®.TB) at PKUPH from November 2016 to October 2018 were reviewed. Active TB cases were considered according to a composite reference standard (CRS). Then, the three methods were evaluated and compared. Results: In total, 787 patients simultaneously tested with Xpert, AFB, and IGRA were enrolled; among them 11.3% (89/787) were diagnosed and confirmed active pulmonary TB (PTB, 52 cases), extrapulmonary TB (EPTB, 17 cases), and tuberculous pleurisy (TP, 20 cases). The sensitivity of Xpert in detecting PTB, EPTB, and TP was 88.

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Section: Discussionsupporting

confidence: 92%

A retrospective study on Xpert MTB/RIF for detection of tuberculosis in a teaching hospital in China

Lin

Zhang

et al. 2020

BMC Infect Dis

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“…The T-SPOT.TB test had a comparatively higher sensitivity than that of the TST, which was consistent with the results of certain previous meta-analyses (6,12). However, compared to most data for cohorts from developed countries (3,12), a lower specificity (68.1%) and PPV (47.2%) of the T-SPOT.TB was determined in the present study, which is more consistent with the result of one large-scale retrospective multicenter study from China (13). The accuracy of the TST and T-SPOT.…”

Section: Discussionsupporting

confidence: 91%

Correlation between the tuberculin skin test and T‑SPOT.TB in patients with suspected tuberculosis infection: A pilot study

Yang

Kong

et al. 2019

Exp Ther Med

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T-SPOT.TB is a novel screening method for Mycobacterium tuberculosis infection. However, it is controversial whether T-SPOT.TB should become an alternative method to the tuberculin skin test (TST) for screening M. tuberculosis infections. The present study aimed to evaluate this issue based on the retrospective analysis of clinical cases. TST and T-SPOT.TB tests were used on patients with suspected M. tuberculosis infection on admission. Demographic data and clinical information, including previous history of M. tuberculosis infection, were collected. A total of 118 patients were included in the analysis, among whom 30 (25.4%) were diagnosed with active M. tuberculosis infection, and seven patients (5.9%) were currently receiving immunosuppressive treatment. The overall sensitivity and specificity of the TST were 76.7 and 77.3%, respectively, while they were 88.3 and 68.1%, respectively, for the T-SPOT.TB test. Patients with large TST indurations had a higher number of gamma interferon-producing T cells among peripheral blood mononuclear cells compared with those of TST-negative patients. In conclusion, the T-SPOT.TB test had a higher sensitivity than the TST, but the difference was not statistically significant. Neither the T-SPOT.TB test nor the TST was sufficiently accurate to detect active M. tuberculosis infection. Materials and methods Participants and data collection. A retrospective analysis was performed on patients diagnosed at the Respiratory Department of Ningbo First Hospital (Ningbo, China) between October 2016 and 2017. A total of 118 patients who were suspected of active TB infection on admission were included in the analysis. Each patient was subjected to the TST as well as the T-SPOT.TB test. The patients' demographics and clinical information, including previous history of TB, were collected. Definitions and diagnoses. Final diagnoses were made considering all clinical, radiological, microbiological and pathological information. Patients who had clinical, bacteriological and/or

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“…TB is lower than the T-SPOT. TB false-negative rate of 6.74% (61/905) reported in a previous study [24]. This discrepancy may be due to inconsistencies in case inclusion criteria and to the existence of different comorbidities.…”

Section: Discussionmentioning

confidence: 88%

Quantitative investigation of factors relevant to the T cell spot test for tuberculosis infection in active tuberculosis

Yang

Jiang

et al. 2019

Preprint

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23Background 24 Previous qualitative studies suggested that the false negative rate of T cell spot test 25 for tuberculosis infection (T-SPOT.TB) is associated with many risk factors in 26 tuberculosis patients; However, more precise quantitative studies are not well known. 27 Objective 28 To investigate the factors affecting quantified T-SPOT.TB in patients with active 29 tuberculosis.30Methods 31 We retrospectively analyzed the data of 360 patients who met the inclusion criteria. 32 Using the levels of early secreted antigenic target 6 kDa (ESAT-6) and culture filtrate 33 protein 10 kDa (CFP-10) as dependent variables, variables with statistical 34 significance in the univariate analysis were subjected to optimal scaling regression 35 analysis. 36 Results 37The results showed that the ESAT-6 regression model had statistical significance 38 (P-trend < 0.001) and that previously treated cases, CD4+ and platelet count were its 39 independent risk factors (all P-trend < 0.05); their importance levels were 0.095, 40 0.596 and 0.100, respectively, with a total of 0.791. The CFP-10 regression model 41 also had statistical significance (P-trend < 0.001); platelet distribution width and 42 alpha-2 globulin were its independent risk factors (all P-trend < 0.05), their 43 importance levels were 0.287 and 0.247, respectively, with a total of 0.534. The 44 quantification graph showed that quantified T-SPOT.TB levels had a linear correlation 45 3 with risk factors. 46 Conclusion 47 The test results of T-SPOT.TB should be given more precise explanations, especially 48 in patients with low levels of CD4+, platelet, alpha-2 globulin and high platelet 49 distribution width. 50 51 Introduction 52 The interferon-gamma release assay (IGRA) represents one of the most important 53 advances in the immunodiagnosis of Mycobacterium tuberculosis (MTB) infection in 54 the past two decades. As a new adjuvant method for the diagnosis of MTB infection, 55 IGRA has been widely applied and accepted clinically. In principle, IGRA determines 56 whether the subject is infected with MTB by examination of the levels of released 57 γ -interferon (IFN-γ) after stimulation of whole blood or peripheral blood mononuclear 58 cells (PBMCs) with MTB-specific antigen. This test is not affected by Bacillus 59 Calmette-Guerin (BCG) vaccination [1], a feature that is very beneficial in countries 60 such as China in which general BCG vaccination is practiced. Currently, the T cell 61 spot test for tuberculosis infection (T-SPOT.TB) is the main IGRA test method; it 62 provides intuitive and reproducible results and quantitatively reflects the number of 63 IFN-γ secreting cells in preparations of PBMCs [2]. 64 IGRA still has a certain false negative rate among patients with tuberculosis (TB). 65 Previous studies reported that negative bacteria in sputum [3-5], hypoproteinemia 66 [6-8], combined HIV infection [4, 7, 9], anti-TB treatment [10, 11], medical history [8, 67 4 12], anemia [6, 13], diabetes [14], parasitic infections [13], noncavitary lesion...

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Interferon-Gamma Release Assay is Not Appropriate for the Diagnosis of Active Tuberculosis in High-Burden Tuberculosis Settings

Cited by 16 publications

References 28 publications

A retrospective study on Xpert MTB/RIF for detection of tuberculosis in a teaching hospital in China

A retrospective study on Xpert MTB/RIF for detection of tuberculosis in a teaching hospital in China

Correlation between the tuberculin skin test and T‑SPOT.TB in patients with suspected tuberculosis infection: A pilot study

Quantitative investigation of factors relevant to the T cell spot test for tuberculosis infection in active tuberculosis

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