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The sensitivity of interferon-gamma release assays is not compromised in tuberculosis patients with diabetes.

ABSTRACT: the sensitivity of the interferon-gamma release assays (IGRAs) in the detection of Mycobacterium tuberculosis infection or disease may be affected by immune dysregulation in diabetes. As millions of type 2 diabetes patients are at risk for tuberculosis (TB) worldwide, it is important to determine if the sensitivity of IGRAs is compromised in this vulnerable population.the sensitivity of the IGRAs QuantiFERON®-TB Gold (QFT-G) and T-SPOT®.TB was evaluated among specimens from newly diagnosed adults with microbiologically confirmed TB with and without diabetes. We also evaluated the association between QFT-G results and diabetes-associated conditions (dyslipidemia, obesity).QFT-G sensitivity was 70% among TB patients. Patients with diabetes, chronic hyperglycemia or overweight/obesity were more than twice as likely to have positive test results in multivariate models (P < 0.05). Low high-density lipoprotein cholesterol or high triglycerides were not associated with assay results. In a separate group of TB patients (n = 43), T-SPOT.TB was 93% sensitive, with similar performance in patients with and without diabetes.IGRA sensitivity is not compromised by diabetes in TB patients. Accordingly, IGRAs may also be suitable for diagnosing TB infection in diabetes patients, which is required to assess TB risk.

SUBMITTER: Walsh MC

PROVIDER: S-EPMC3085021 | biostudies-literature | 2011 Feb

REPOSITORIES: biostudies-literature

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The sensitivity of interferon-gamma release assays is not compromised in tuberculosis patients with diabetes.

Walsh M C MC Camerlin A J AJ Miles R R Pino P P Martinez P P Mora-Guzmán F F Crespo-Solis J G JG Fisher-Hoch S P SP McCormick J B JB Restrepo B I BI

The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease 20110201 2

<h4>Setting and objectives</h4>the sensitivity of the interferon-gamma release assays (IGRAs) in the detection of Mycobacterium tuberculosis infection or disease may be affected by immune dysregulation in diabetes. As millions of type 2 diabetes patients are at risk for tuberculosis (TB) worldwide, it is important to determine if the sensitivity of IGRAs is compromised in this vulnerable population.<h4>Design</h4>the sensitivity of the IGRAs QuantiFERON®-TB Gold (QFT-G) and T-SPOT®.TB was evalua ...[more]

PMID: 21219678

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Project description:ImportanceElimination of tuberculosis (TB) disease in the US hinges on the ability of tests to detect individual risk of developing disease to inform prevention. The relative performance of 3 available TB tests-the tuberculin skin test (TST) and 2 interferon-γ release assays (IGRAs; QuantiFERON-TB Gold In-Tube [QFT-GIT] and SPOT.TB [TSPOT])-in predicting TB disease development in the US remains unknown.ObjectiveTo compare the performance of the TST with the QFT-GIT and TSPOT IGRAs in predicting TB disease in high-risk populations.Design, setting, and participantsThis prospective diagnostic study included participants at high risk of TB infection (TBI) or progression to TB disease at 10 US sites between 2012 and 2020. Participants of any age who had close contact with a case patient with infectious TB, were born in a country with medium or high TB incidence, had traveled recently to a high-incidence country, were living with HIV infection, or were from a population with a high local prevalence were enrolled from July 12, 2012, through May 5, 2017. Participants were assessed for 2 years after enrollment and through registry matches until the study end date (November 15, 2020). Data analysis was performed in June 2023.ExposuresAt enrollment, participants were concurrently tested with 2 IGRAs (QFT-GIT from Qiagen and TSPOT from Oxford Immunotec) and the TST. Participants were classified as case patients with incident TB disease when diagnosed more than 30 days from enrollment.Main outcomes and measuresEstimated positive predictive value (PPV) ratios from generalized estimating equation models were used to compare test performance in predicting incident TB. Incremental changes in PPV were estimated to determine whether predictive performance significantly improved with the addition of a second test. Case patients with prevalent TB were examined in sensitivity analysis.ResultsA total of 22 020 eligible participants were included in this study. Their median age was 32 (range, 0-102) years, more than half (51.2%) were male, and the median follow-up was 6.4 (range, 0.2-8.3) years. Most participants (82.0%) were born outside the US, and 9.6% were close contacts. Tuberculosis disease was identified in 129 case patients (0.6%): 42 (0.2%) had incident TB and 87 (0.4%) had prevalent TB. The TSPOT and QFT-GIT assays performed significantly better than the TST (PPV ratio, 1.65 [95% CI, 1.35-2.02] and 1.47 [95% CI, 1.22-1.77], respectively). The incremental gain in PPV, given a positive TST result, was statistically significant for positive QFT-GIT and TSPOT results (1.64 [95% CI, 1.40-1.93] and 1.94 [95% CI, 1.65-2.27], respectively).Conclusions and relevanceIn this diagnostic study assessing predictive value, IGRAs demonstrated superior performance for predicting incident TB compared with the TST. Interferon-γ release assays provided a statistically significant incremental improvement in PPV when a positive TST result was known. These findings suggest that IGRA performance may enhance decisions to treat TBI and prevent TB.

Project description:BackgroundWe aimed to assess whether interferon-γ release assays (IGRAs) can predict the development of active tuberculosis and whether the predictive ability of these tests is better than that of the tuberculin skin test (TST).MethodsLongitudinal studies of the predictive value for active tuberculosis of in-house or commercial IGRAs were identified through searches of PubMed, Embase, Biosis, and Web of Science and complementary manual searches up to June 30, 2011. Eligible studies included adults or children, with or without HIV, who were free of active tuberculosis at study baseline. We summarised incidence rates in forest plots and pooled data with random-effects models when appropriate. We calculated incidence rate ratios (IRR) for rates of disease progression in IGRA-positive versus IGRA-negative individuals.Findings15 studies had a combined sample size of 26 680 participants. Incidence of tuberculosis during a median follow-up of 4 years (IQR 2-6), even in IGRA-positive individuals, was 4-48 cases per 1000 person-years. Seven studies with no possibility of incorporation bias and reporting baseline stratification on the basis of IGRA results showed a moderate association between positive results and subsequent tuberculosis (pooled unadjusted IRR 2·10, 95% CI 1·42-3·08). Compared with test-negative results, IGRA-positive and TST-positive results were much the same with regard to the risk of tuberculosis (pooled IRR in the five studies that used both was 2·11 [95% CI 1·29-3·46] for IGRA vs 1·60 [0·94-2·72] for TST at the 10 mm cutoff). However, the proportion of IGRA-positive individuals in seven of 11 studies that assessed both IGRAs and TST was generally lower than TST-positive individuals.InterpretationNeither IGRAs nor the TST have high accuracy for the prediction of active tuberculosis, although use of IGRAs in some populations might reduce the number of people considered for preventive treatment. Until more predictive biomarkers are identified, existing tests for latent tuberculosis infection should be chosen on the basis of relative specificity in different populations, logistics, cost, and patients' preferences rather than on predictive ability alone.FundingSpecial Programme for Research and Training in Tropical Diseases (WHO), Wellcome Trust, Canadian Institutes of Health Research, UK Medical Research Council, and the European and Developing Countries Clinical Trials Partnership.

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The sensitivity of interferon-gamma release assays is not compromised in tuberculosis patients with diabetes.

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The sensitivity of interferon-gamma release assays is not compromised in tuberculosis patients with diabetes.

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