Agreement between QuantiFERON®-TB Gold In-Tube and the tuberculin skin test and predictors of positive test results in Warao Amerindian pediatric tuberculosis contacts

Verhagen, Lilly M.; Maes, Mailis; Villalba, Julian A.; D'Alessandro, Adriana; Rodriguez, Lazaro Perez; España, Mercedes; Hermans, Peter W. M.; Waard, Jacobus H. de

doi:10.1186/1471-2334-14-383

Cited by 14 publications

(12 citation statements)

References 49 publications

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“…Results have been conflicting at times, with some studies showing comparable sensitivity and specificity to TST, whereas others found higher or lower sensitivity. 3,[26][27][28][29][30][31][32] Rates of indeterminate QFT tests have been higher in young children than in adults; 26,[33][34][35][36] although in this study, we noted a low rate of indeterminate tests (0·4% of all tests).…”

Section: Discussionmentioning

confidence: 54%

Serial QuantiFERON testing and tuberculosis disease risk among young children: an observational cohort study

Andrews

Nemes

Tameris

et al. 2017

The Lancet Respiratory Medicine

122

113

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Background: The value of quantitative interferon-γ release assay results for predicting progression from Mycobacterium tuberculosis infection to active disease is unknown. Methods: We analysed data from a reported vaccine efficacy trial of MVA85A in South Africa. QuantiFERON-TB Gold In-Tube (QFT) negative, HIV uninfected infants aged 18–24 weeks were enrolled. We stratified participants by quantitative QFT result (IFN-γ <0.35, 0·35–4·00, >4·00 IU/ml) at the intermediate study visit (Day 336) and determined risk of progression to active tuberculosis disease over the subsequent 6–24 months. No QFT differences were observed between placebo and MVA85A groups; therefore, both groups were included in analyses. Study clinicians were not blinded to QFT values, but strict case definitions were used and excluded QFT results. Findings: Among 2,512 infants with QFT tests performed at Day 336, 172 (6·8%) were positive. Compared with QFT non-converters (disease incidence 0·7 per 100 person-years; 95% CI: 0·4–1·1), children with QFT conversion at IFN-γ values between 0·35–4·00 IU/ml did not have significantly increased risk of disease (2·5 per 100 person-years; 95% CI: 0·4–9·4; IRR 3·7; p=0·23). However, QFT conversion at IFN-γ values >4·00 IU/ml was associated with markedly increased disease incidence (28·0 per 100 person-years; 95% CI: 14·9–45·7) compared to nonconverters (IRR 42·5; p<0·0001); and compared to children with IFN-γ values between 0·35–4·00 IU/ml (IRR: 11·4; p=0·00047). Among 91 QFT converters with a repeat test, 53 (58·2%) reverted from positive to negative. QFT reversion risk was inversely associated with IFN-γ value at QFT conversion and was highest (47/61; 77·0%) with IFN-γ values <4·00 IU/ml. Interpretation: In young children, tuberculosis disease risk was not significantly elevated, and QFT reversion was common, following QFT conversion at IFN-γ values up to 10 times the recommended test threshold. By contrast, QFT conversion at very high IFN-γ values (>4·00 IU/ml) warrants intensified diagnostic and preventive intervention for extremely high risk of tuberculosis disease.

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Section: Discussionmentioning

confidence: 54%

Serial QuantiFERON testing and tuberculosis disease risk among young children: an observational cohort study

Andrews

Nemes

Tameris

et al. 2017

The Lancet Respiratory Medicine

122

113

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“…Many of these 59 studies did not have the primary aim of assessing diagnostic accuracy. Many recorded few cases of active TB (often < 10) 22,[25][26][27][29][30][31][32][33][35][36][37][38]40,[42][43][44][45]47,48,50,51,[56][57][58][59][62][63][64][65][67][68][69][70][71][72][73][74][75]77,78 and/or were restricted to groups such as patients infected with HIV, 9,28,29,36,49,51,56,60,65,…”

Section: Diagnostic Performance Of Interferon Gamma Release Assays Fomentioning

confidence: 99%

“…Of these, five assessed both IGRAs and TST. 23,52,56,62,72 Except when noted, these studies did not include treatment for LTBI. In this subset of studies, estimates of the PPVs ranged from < 1% to 17%, whereas the NPV was ≥ 97%.…”

Section: Diagnostic Performance Of Interferon Gamma Release Assays Fomentioning

confidence: 99%

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Two interferon gamma release assays for predicting active tuberculosis: the UK PREDICT TB prognostic test study

Abubakar

Lalvani

Southern

et al. 2018

Health Technol Assess

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Background Despite a recent decline in the annual incidence of tuberculosis (TB) in the UK, rates remain higher than in most Western European countries. The detection and treatment of latent TB infection (LTBI) is an essential component of the UK TB control programme. Objectives To assess the prognostic value and cost-effectiveness of the current two interferon gamma release assays (IGRAs) compared with the standard tuberculin skin test (TST) for predicting active TB among untreated individuals at increased risk of TB: (1) contacts of active TB cases and (2) new entrants to the UK from high-TB-burden countries. Design A prospective cohort study and economic analysis. Participants and setting Participants were recruited in TB clinics, general practices and community settings. Contacts of active TB cases and migrants who were born in high-TB-burden countries arriving in the UK were eligible to take part if they were aged ≥ 16 years. Main outcome measures Outcomes include incidence rate ratios comparing the incidence of active TB in those participants with a positive test result and those with a negative test result for each assay, and combination of tests and the cost per quality-adjusted life-year (QALY) for each screening strategy. Results A total of 10,045 participants were recruited between May 2010 and July 2015. Among 9610 evaluable participants, 97 (1.0%) developed active TB. For the primary analysis, all test data were available for 6380 participants, with 77 participants developing active TB. A positive result for TSTa (positive if induration is ≥ 5 mm) was a significantly poorer predictor of progression to active TB than a positive result for any of the other tests. Compared with TSTb [positive if induration is ≥ 6 mm without prior bacillus Calmette–Guérin (BCG) alone, T-SPOT®.TB (Oxford Immunotec Ltd, Oxford, UK), TSTa + T-SPOT.TB, TSTa + IGRA and the three combination strategies including TSTb were significantly superior predictors of progression. Compared with the T-SPOT.TB test alone, TSTa + T-SPOT.TB, TSTb + QuantiFERON® TB Gold In-Tube (QFT-GIT; QIAGEN GmbH, Hilden, Germany) and TSTb + IGRA were significantly superior predictors of progression and, compared with QFT-GIT alone, T-SPOT.TB, TSTa + T-SPOT.TB, TSTa + QFT-GIT, TSTa + IGRA, TSTb + T-SPOT.TB, TSTb + QFT-GIT and TSTb + IGRA were significantly superior predictors of progression. When evaluating the negative predictive performance of tests and strategies, negative results for TSTa + QFT-GIT were significantly poorer predictors of non-progression than negative results for TSTa, T-SPOT.TB and TSTa + IGRA. The most cost-effective LTBI testing strategies are the dual-testing strategies. The cost and QALY differences between the LTBI testing strategies were small; in particular, QFT-GIT, TSTb + T-SPOT.TB and TSTb + QFT-GIT had very similar incremental net benefit estimates. Conclusion This study found modest differences between tests, or combinations of tests, in identifying individuals who would go on to develop active TB. However, a two-step approach that combined TSTb with an IGRA was the most cost-effective testing option. Implications for practice and future research The two-step TSTb strategy, which stratified the TST by prior BCG vaccination followed by an IGRA, was the most cost-effective approach. The limited ability of current tests to predict who will progress limits the clinical utility of tests. The implications of these results for the NHS England/Public Health England national TB screening programme for migrants should be investigated. Study registration This study is registered as NCT01162265. Funding The National Institute for Health Research Health Technology Assessment programme.

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“…The low IFNG expression levels detected may be correlated with the present findings in relation to QFT-IT assays; among the LTBI indigenous individuals tested, only 4 of were QFT-IT+. In this context, the value of the QFT-IT as an adjunct in diagnosing latent infection in Warao individuals may be limited: in Warao children for whom both TST and QFT-IT results are available, the proportion of children with a positive TST was high compared with those with a positive QFT-IT 22 . The latter correlates with the present results; therefore, replacement of the TST by QFT-IT for detection of M. tuberculosis infection is not recommended in this indigenous population.…”

Section: Discussionmentioning

confidence: 99%

Concordance between IFNγ gene +874 A/T polymorphism and interferon-γ expression in a TB-endemic indigenous setting

Araujo

Palacios

Biomon

et al. 2017

Rev. Soc. Bras. Med. Trop.

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Introduction: Interferon-γ (IFN-γ) plays a crucial role in resistance to mycobacterial diseases; accordingly, variants of the gene encoding this cytokine may be associated with elevated risk of contracting pulmonary tuberculosis (TB). Methods: Blood samples were collected from 135 Warao indigenous individuals with newly diagnosed sputum culture-positive TB. Of these, 24 were diagnosed with active tuberculosis (ATB). The study comprised 111 participants, who were grouped as follows: 1) 14 tuberculin skin test (TST)-positive Warao indigenous individuals and 4 that were QuantiFERON-TBGold In-Tube (QFT-IT) test-positive, collectively comprising the latent TB infection group (LTBI), n = 18), and 2) healthy controls who were QFT-ITand TST-negative, comprising the control group (CTRL, n = 93). Detection of the IFN γ gene (IFNG) +874A/T polymorphism was performed via PCR and quantification of IFNG expression via qPCR. Results: Relative to indigenous and white Americans, ATB and CTRL groups had a higher frequency of the IFNG SNP (+874A): 23 (95.8%) and 108 (97.3%), respectively. Indigenous Warao individuals homozygous for the IFNG (+874) A allele exhibited 3.59-fold increased risk of developing TB (95% confidence interval, 2.60-4.96, p =0.0001). A decreased frequency of the AT genotype was observed in individuals with pulmonary TB (4.16%) and controls (0.90%). The frequency of the TT genotype was decreased among controls (1.80%); none of the patients with TB were found to have this genotype. The differences in IFNG expression between the groups, under unstimulated and stimulated conditions, were not statistically significant. Conclusions: Preliminary results demonstrate concordance between IFNG +874 A/A genotype and low expression of IFNG.

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Agreement between QuantiFERON®-TB Gold In-Tube and the tuberculin skin test and predictors of positive test results in Warao Amerindian pediatric tuberculosis contacts

Cited by 14 publications

References 49 publications

Serial QuantiFERON testing and tuberculosis disease risk among young children: an observational cohort study

Serial QuantiFERON testing and tuberculosis disease risk among young children: an observational cohort study

Two interferon gamma release assays for predicting active tuberculosis: the UK PREDICT TB prognostic test study

Concordance between IFNγ gene +874 A/T polymorphism and interferon-γ expression in a TB-endemic indigenous setting

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