2Introduction: Sensitivity for active tuberculosis (TB) of Interferon Gamma Release Assay (IGRA) tests has been estimated to be around 80%. As a consequence, individual centers will not observe enough IGRA-negative TB patients to identify the factors associated with false negative IGRA results in active disease. So far, identified risk factors for a false negative IGRA test comprise immunodeficiency, age, Smoking, extra-pulmonary and disseminated disease, concomitant TB treatment. Methods: We conducted an international, multicenter, retrospective study to identify factors associated with a negative IGRA result in patients with a microbiology-confirmed diagnosis of active TB. We calculated that 500 subjects for each test would have been needed to reliably predict the factors associated with false negative test results. Results: Twenty-five centers participated in the study and data were obtained from Europe, Asia and Africa: 872 patients were enrolled and 107 (22.6%) were excluded due to missing data. Of the remaining 765 patients, 596 were tested with the QuantiFERON (QFT) assay , 82 with T-SPOT.TB (TS.TB) and 87 with both tests. A preliminary univariate analysis identified smoking (OR=0.52), solid malignancy (OR=0.44) and age as the only 3 factors associated with a false negative TS.TB. QFT results were negatively correlated by gender (OR=0.78), age, HIV status (OR=1.48), diabetes mellitus (OR=1.77) and a false negative skin test result (OR=0.4). Furthermore, the use of immunosuppressive drugs (OR=2.79) or any immune deficiency (OR=1.6) negatively affected QFT results. Conclusions: Although we calculated that 500 subjects for each test-platform were needed, because of the low number of variables found to be associated with a false negative TS.TB result, the sample size study was sufficiently powered to allow analysis for both test platforms. In univariate analysis, known factors associated with a false negative skin test were also found to be associated with false negative IGRA results. Furthermore, several additional factorsfor false negative IGRA were identified. The two platforms considerably differed in terms of variables identified in a false negative result.
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