Recently, interferon-γ release assays (IGRAs) have emerged as immunodiagnostic tools to detect tuberculous infection. Conclusive diagnostic tests, including microbial culture and smear for acid-fast bacilli, are not sensitive enough to identify all the active cases 4. Despite incorporation of clinical, radiological, pathological and microbiological examinations, TB diagnosis can still be difficult. Early and accurate diagnosis of active TB is critical to the care of TB patients and to control transmission in these high-burden developing countries. China is ranked third, worldwide (after India and Indonesia), with 918 thousand new cases of TB every year 1, 2, 3. In 2015, there were an estimated 10.4 million new TB cases worldwide. Tuberculosis (TB) is an airborne-transmitted infectious disease with high morbidity and mortality. However, neither of them showed suitability in the definitive diagnosis of the disease. Although having some heterogeneity in detecting interferon-γ release, both the QFT-GIT and T-SPOT.TB demonstrated high concordance in diagnosing ATB. The two assays have an overall agreement of 92.3%, but exhibited a poor linear correlation (r 2 = 0.086) between the levels of interferon-γ release detected by the different assays. When excluding ITRs, the sensitivities of T-SPOT.TB and QFT-GIT were 85.2% and 84.8%, and specificities of 63.4% and 60.5%, respectively in the diagnosis of ATB. Furthermore, the rate of ITRs determined by T-SPOT.TB was lower than QFT-GIT (0.4% vs. Of 32 patients with indeterminate test results (ITRs), age and underlying disease were associated with the rate of ITRs. A total of 746 suspected pulmonary TB were enrolled and categorized, including 185 confirmed TB, 298 probable TB and 263 non-TB. A multicenter, prospective comparison study was undertaken at four hospitals specializing in pulmonary diseases. Especially, there are no reports on comparing the efficacy between the two tests in the same population in China. T-SPOT.TB and QuantiFERON-TB Gold In-Tube (QFT-GIT) tests, as two commercial blood assays for diagnosing active tuberculosis (ATB), are not yet fully validated.
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