Risk factors for false-negative T-SPOT.TB assay results in patients with pulmonary and extra-pulmonary TB

Pan, Liping; Jia, Hongyan; Liu, Fei; Sun, Huishan; Gao, Mengqiu; Du, Fengjiao; Xing, Aiying; Du, Boping; Sun, Qi; Wei, Rongrong; Gu, Song; Zhang, Zongde

doi:10.1016/j.jinf.2014.12.018

Cited by 58 publications

(64 citation statements)

References 78 publications

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“…Advanced age. Pooled odds ratio (pooled OR: 2.06, 95% CI 1.68-2.52) of advanced age calculated with raw data available in 5 of the 14 included studies 6,8,15,20,22 showed a significant relationship between advanced age and false negative results with very low heterogeneity (Fig. 2).…”

Section: Resultsmentioning

confidence: 98%

“…We finally included 17 studies in this systematic review: 14 6,7,13-24 and 3 studies 8,25,26 were retrospective and prospective observational studies, respectively. These published studies, 4 from low-incidence countries: United States of America (n = 2) 6,22 , Denmark (n = 1) 13 and the EU (n = 1) 14 ; 11 from middle-incidence countries: South Korea (n = 6) 14, [16][17][18]20,26 and China (n = 4) 8,13,15,21 and Japan (n = 1) 7 ; and 3 from high-incidence countries: Viet Nam (n = 1) 25 , Tanzania (n = 1) 13 and Zambia (n = 1) 23 . The results from Denmark and Tanzania were reported collectively in one study 13 .…”

Section: Resultsmentioning

confidence: 99%

“…The results from Denmark and Tanzania were reported collectively in one study 13 . Six studies evaluated risk factors for false negative results of IGRAs in a non-HIV population 7,8,16,18,20,24 (Table 1). How many times the IGRA was performed per sample was not mentioned in any study included in this review.…”

Section: Resultsmentioning

confidence: 99%

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Factors associated with false negative interferon-γ release assay results in patients with tuberculosis: A systematic review with meta-analysis

Yamasue

Komiya

Usagawa

et al. 2020

Sci Rep

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Which factors are related to false negative results of the interferon-γ release assay (iGRA) is unclear. This systematic review described the risk factors associated with false negative IGRA results. Two authors independently identified studies designed to evaluate risk factors for false negative IGRA results from PubMed, the Cochrane Register of Control Trial database, and EMBASE, accessed on October 22, 2018. Meta-analyses were conducted with random-effect models, and heterogeneity was calculated with the I 2 method. Of 1,377 titles and abstracts screened, 47 full texts were selected for review, and we finally included 17 studies in this systematic review. The most commonly studied risk factor (14 studies) was advanced age, followed by low peripheral lymphocyte counts (7 studies), and these factors were associated with false negative results even with different tuberculosis incidences (pooled odds ratio 2.06; 95% CI, 1.68-2.52 in advanced age and 2.68; 95% CI, 2.00-3.61 in low peripheral lymphocyte counts). Advanced age and low peripheral lymphocyte counts may be common risk factors for false negative IGRA results, suggesting that people with these factors need to be carefully followed, even if they have negative iGRA results.

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Section: Resultsmentioning

confidence: 98%

Section: Resultsmentioning

confidence: 99%

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Factors associated with false negative interferon-γ release assay results in patients with tuberculosis: A systematic review with meta-analysis

Yamasue

Komiya

Usagawa

et al. 2020

Sci Rep

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“…Previous studies reported that negative bacteria in sputum [3-5], hypoproteinemia [6-8], combined HIV infection [4, 7, 9], anti-TB treatment [10, 11], medical history [8, 12], anemia [6, 13], diabetes [14], parasitic infections [13], noncavitary lesions in the lung [5], fall and winter seasons [15], increased human leukocyte antigen DRB1-0701 allele [16] and non-Hispanic white or Asian ethnicity [6, 9] are risk factors for false negative IGRA. The association between IGRA and age [3, 7-9, 12, 13, 15-18], body mass index [12, 16] and reduced lymphocyte levels [3, 5, 7, 8, 17, 19, 20] is inconsistent among previous studies. Some of these studies were qualitative studies with small samples and did not consider the possibility that different antigen risk factors might have confounded or biased the results.…”

Section: Introductionmentioning

confidence: 99%

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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“…We read with interest the recent article by Pan et al, 1 which highlighted that a substantial proportion of patients with pulmonary and extrapulmonary tuberculosis (TB) have false-negative interferon-gamma release assay (IGRA) results, showing that a negative IGRA result does not rule out active TB. Unfortunately the authors excluded indeterminate assay results from the analyses, despite those results posing a considerable dilemma for clinical management, as they confer no information about the patient's TB infection status.…”

Section: Dear Editormentioning

confidence: 99%

Environmental temperature impacts on the performance of QuantiFERON-TB Gold In-Tube assays

Jarvis¹,

Gao²,

Hughes³

et al. 2015

Journal of Infection

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Risk factors for false-negative T-SPOT.TB assay results in patients with pulmonary and extra-pulmonary TB

Cited by 58 publications

References 78 publications

Factors associated with false negative interferon-γ release assay results in patients with tuberculosis: A systematic review with meta-analysis

Factors associated with false negative interferon-γ release assay results in patients with tuberculosis: A systematic review with meta-analysis

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

Environmental temperature impacts on the performance of QuantiFERON-TB Gold In-Tube assays

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