Detection and Prediction of Active Tuberculosis Disease by a Whole‐Blood Interferon‐γ Release Assay in HIV‐1–Infected Individuals

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Abstract
Background. The sensitivity of whole-blood interferon-γ release assays to detect or predict active tuberculosis in individuals infected with human immunodeficiency virus type 1 (HIV-1) has as yet not been determined. Methods. In this prospective, longitudinal, single-center study, 830 HIV-1–infected patients underwent testing with the QuantiFERON-TB Gold In-Tube (QFT-GIT) assay. Clinical screening for active tuberculosis was performed at least every 3 months for a median follow-up time of 19 months. Results. At baseline, the QFT-GIT assay yielded positive or indeterminate results in 44 (5.3%) and 47 (5.7%) of the 830 patients, respectively. A positive QFT-GIT assay result occurred at significantly higher frequencies among black individuals than among white individuals (odds ratio, 4.84; 95% confidence interval, 2.25–9.97; P<.001), among patients from Africa than among patients from Austria (odds ratio, 6.57; 95% confidence interval, 2.99–14.25; P<.001), and among patients from high-prevalence countries than among patients from low-prevalence countries (odds ratio, 5.86; 95% confidence interval, 2.41–13.44; P<.001). In patients with indeterminate QFT-GIT assay results, both median actual and nadir CD4>+ T cell counts were significantly lower than in patients with interpretable QFT-GIT assay results (P<.001). At the time of baseline QFT-GIT screening, active tuberculosis was found in 7 (15.9%) of 44 individuals with a positive result and in 1 (0.1%) of 739 patients with a negative result. During the follow-up period, however, progression to active tuberculosis occurred exclusively in patients with a positive QFT-GIT assay result, at a rate of 8.1% (3 of 37 patients; P<.001). Collectively, the sensitivity of the QFT-GIT assay for active tuberculosis was 90.9% (95% confidence interval, 62.3%–98.4%). Conclusions. Our results suggest that the QFT-GIT assay may be a sensitive tool for the detection and prediction of active tuberculosis in HIV-1–infected individuals.

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