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The performance of the interferon gamma release assays (IGRAs) and tuberculin skin test (TST) was reviewed retrospectively in patients with psoriasis, inflammatory musculoskeletal diseases, or miscellaneous inflammatory conditions. The study was carried out over a 22-month period using 109 records of patients with psoriasis ( 𝑛 = 2 1 ), musculoskeletal disease ( 𝑛 = 7 4 ), or other inflammatory conditions ( 𝑛 = 1 4 ). Forty-four (48%) of 109 patients were on immunosuppressive therapy and 38/109 (35%) on systemic glucocorticoid therapy. The agreement between the IGRAs was substantial ( 𝜅 = 0 . 7 1 ) whilst that between the IGRAs and TST was low ( 𝜅 = 0 . 3 2 ). Logistic regression models revealed that IGRAs associated with risk factors for latent tuberculosis infection better than TST. TST was influenced by age, BCG vaccination, sex, and glucocorticoid therapy. We found that IGRAs performed equally well with low level of indeterminate results (1-2%). IGRAs were superior to TST because the latter was influenced by BCG-vaccination status and immunosuppressive therapy.

New gamma interferon (IFN-γ) release assays (IGRAs) to detect an exposure to Mycobacterium tuberculosis have recently been launched. The majority of the studies in temperate-climate countries agree that these methods have superior specificity and equal or even superior sensitivity over tuberculin skin tests (TSTs) in the diagnosis of latent tuberculosis (TB) infection (LTBI). However, reproducibility data of IGRAs are virtually missing. We assessed within-run, between-run, and total imprecision of two commercial IGRAs by testing samples from subjects with a stable state of TB infection or treated pulmonary TB, a sample from a healthy volunteer, and internal quality control samples. We calculated coefficients of variance (CV%s) to describe assays variability and compared the obtained results to the reported CV%s for other commercial immunodiagnostic methods. We illustrate an example of assay variability near the cutoff zone to demonstrate the necessity of a gray zone. Due to the strict adherence to the standard operation procedures (SOP) adopted in our laboratory, the total imprecision of enzyme-linked immunospot (ELISPOT)- and enzyme immunoassay (EIA)-based IGRAs was at a maximum CV% of 37.8% for the samples with moderate and high reactivities. Imprecision of testing samples with very low reactivity levels or nonreactive samples may, however, exceed 100%. In conclusion, despite multiple steps of the method performance, the analytical imprecision of IGRAs, which in our study design included also between-lot variability and had a component of normal biological variation, was well in accordance with the reported imprecisions of other manual immunodiagnostic tests. The recognition of the variability around the cutoff point advocates the use of a gray zone to avoid ambiguous result interpretations.

Background Two commercial interferon gamma release assays (IGRAs) (QuantiFERON®-TB Gold in Tube and T SPOT®-TB) to detect a contact with M. tuberculosis have recently become available. The majority of studies agree that the sensitivity and specificity of these methods are superior to the Tuberculin Skin Tests (TSTs) in detecting an exposure to bacteria in latently infected individuals and in clinical tuberculosis. However, the data in children remains limited. Findings Consecutively collected samples from children (n = 99) representing age range from zero to 18 years were analyzed in a retrospective non-blinded study. The two IGRAs were modified and adapted to the needs of Finland, a country of a low tuberculosis incidence. For 27 children, both tests were performed simultaneously and compared with the TST and clinician's diagnosis. The sensitivity, specificity, and accuracy of both IGRAs was determined. QuantiFERON TB Gold and T SPOT-TB performed (respectively) as follows: sensitivities 0.92 (95% confidence interval, CI, 0.67–0.99) and 0.85 (0.64–0.95); specificities 0.91 (0.77–0.97) and 1.00 (0.93–1.00); accuracies 0.91 (0.80–0.97) and 0.96 (0.88–0.99). This compares favorably to the TST whose known figures are 0.90, 0.95, and 0.95, respectively. The agreement between the IGRAs was high, k = 0.89. Finally, both methods agreed well with the TST, k = 0.86 for TST/QuantiFERON-TB Gold and k = 0.76 for TST/T SPOT-TB. Conclusion The sensitivity and specificity of IGRA methods compares well with the TST without the inconveniences and complications associated with TST, including exaggerated delayed type hypersensitivity reactions. These properties place them as acceptable substitutes for TST.