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Potential role for interferon-? release assays in tuberculosis screening in a remote Canadian community: a case series.

ABSTRACT: Current Canadian guidelines suggest that neonatal Bacille Calmette-Guérin (BCG) vaccination does not result in false-positive tuberculosis (TB) skin tests, despite a growing body of evidence that interferon-? release assays may be a more specific alternative in identifying latent tuberculosis infections in vaccinated populations. We set out to evaluate the relationship between TB skin tests and interferon-? release assays in patients who previously received neonatal BCG vaccine.All children with a positive skin test at age 14 years in a remote community north of Sioux Lookout, Ontario, were considered for interferon-? release assay testing.Of the 11 children who underwent routine screening at 14 years of age for latent TB infection, 7 had a positive TB skin test (? 10 mm). All 7 of these children had received the BCG vaccine as newborns and all had a negative TB skin test during their routine screening at 4 years of age. No potential exposure to active TB could be identified. Chest radiographs were normal, and none of the children had symptoms suggestive of active TB. The 7 children underwent interferon-? release assay testing using QuantiFERON Gold. All 7 tests were negative.With the addition of interferon-? release assays to routine skin test screening, we provide evidence that neonatal BCG vaccination may contribute to a false-positive skin test in youth at 14 years of age. Consideration should be given to the possibility that neonatal BCG may contribute to false-positive TB skin tests.

SUBMITTER: Kwong W

PROVIDER: S-EPMC5047837 | biostudies-other | 2016 Jul-Sep

REPOSITORIES: biostudies-other

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Potential role for interferon-γ release assays in tuberculosis screening in a remote Canadian community: a case series.

Kwong Wilson W Krahn Thomas T Cleland Ann A Gordon Janet J Wobeser Wendy W

CMAJ open 20160701 3

<h4>Background</h4>Current Canadian guidelines suggest that neonatal Bacille Calmette-Guérin (BCG) vaccination does not result in false-positive tuberculosis (TB) skin tests, despite a growing body of evidence that interferon-γ release assays may be a more specific alternative in identifying latent tuberculosis infections in vaccinated populations. We set out to evaluate the relationship between TB skin tests and interferon-γ release assays in patients who previously received neonatal BCG vaccin ...[more]

PMID: 27730117

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Project description:BACKGROUND:UK tuberculosis (TB) notifications are rising due to disease in the immigrant population. National screening guidelines have been revised but cost-effectiveness analyses are hampered by the lack of data on the comparative performance of tuberculin skin tests (TSTs) and interferon ? release assays (IGRAs) in immigrants. METHODS:Three-way evaluation of TSTs and two IGRAs (QuantiFERON Gold in-tube (QFN-GIT) and T-SPOT.TB) in immigrants aged ?16 years to quantify test positivity, concordance and factors associated with positivity. Yields were computed at different incidence thresholds and the relative cost-effectiveness of screening was estimated using different latent TB infection (LTBI) screening modalities at varying incidence thresholds with or without port-of-arrival chest x-ray (CXR). RESULTS:231 immigrants were included; median age 29 (IQR 24-37). TSTs were accepted by 80.9%, read in 93.5% and 30.3% were positive - QFN-GIT and T-SPOT.TB positive in 16.6% and 22.5% respectively. Positive TSTs, QFN-GIT and T-SPOT.TB were independently associated with increasing TB incidence in immigrants' countries of origin (p=0.007, 0.007, 0.037 respectively). Implementing current guidance (threshold 40/100?000 per year) would identify 98-100% of LTBIs (depending on test) but entail testing 97-99% of the cohort; screening at 150/100?000 per year would identify 49-71% of LTBIs but only entail screening half the cohort. The two most cost-effective screening strategies were no port-of-entry chest radiography and screen with single-step QFN-GIT at 250/100?000 per year (incremental cost-effectiveness ratio (ICER)) £21?565.3/case averted); and no port-of-entry CXR and screen with single-step QFN-GIT at 150/100?000 per year (averted additional 7.8 TB cases; ICER £31?867.1/case averted). CONCLUSIONS:UK immigrant screening could cost-effectively and safely eliminate mandatory CXR on arrival by emphasising systematic screening for LTBI with single-step IGRA. Intermediate incidence thresholds balance the need to identify as many imported LTBIs as possible against limited service capacity.

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:BackgroundThere is growing concern that interferon-? release assays (IGRAs) are being used off-label for the diagnosis of active tuberculosis (TB) disease in many high-burden settings, including India, where the background prevalence of latent TB infection is high. We analyzed the costs and consequences of using IGRAs for the diagnosis of active TB in India from the perspective of the Indian TB control sector.Methods and findingsWe constructed a decision analytic model to estimate the incremental cost and effectiveness of IGRAs for the diagnosis of active TB in India. We compared a reference scenario of clinical examination and non-microbiological tests against scenarios in which clinical diagnosis was augmented by the addition of either sputum smear microscopy, IGRA, or Xpert MTB/RIF. We examined costs (in 2013 US dollars) and consequences from the perspective of the Indian healthcare sector. Relative to sputum smear microscopy, use of IGRA for active TB resulted in 23,700 (95% uncertainty range, UR: 3,800 - 38,300) additional true-positive diagnoses, but at the expense of 315,700 (95% UR: 118,300 - 388,400) additional false-positive diagnoses and an incremental cost of US$49.3 million (95% UR: $34.9 - $58.0 million) (2.9 billion Indian Rupees). Relative to Xpert MTB/RIF (including the cost of treatment for drug resistant TB), use of IGRA led to 400 additional TB cases treated (95% UR: [-8,000] - 16,200), 370,600 (95% UR: 252,200 - 441,700) more false-positive diagnoses, 70,400 (95% UR: [-7,900] - 247,200) fewer disability-adjusted life years averted, and US$14.6 million (95%UR: [-$7.2] - $28.7 million) (854 million Indian Rupees) in additional costs.ConclusionUsing IGRAs for diagnosis of active TB in a setting like India results in tremendous overtreatment of people without TB, and substantial incremental cost with little gain in health. These results support the policies by WHO and Standards for TB Care in India, which discourage the use of IGRAs for the diagnosis of active TB in India and similar settings.

Dataset Information

Potential role for interferon-? release assays in tuberculosis screening in a remote Canadian community: a case series.

Publications

Potential role for interferon-γ release assays in tuberculosis screening in a remote Canadian community: a case series.

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