Evaluation of the QuantiFERON?-TB Gold In-Tube assay and tuberculin skin test for the diagnosis of Mycobacterium tuberculosis infection in northeastern Thailand.

ABSTRACT

BACKGROUND: The diagnosis of latent Mycobacterium tuberculosis infection (LTBI) is currently based on the immunological response of T-cells to M. tuberculosis (MTB) antigens. However, the QuantiFERON®-TB Gold In-Tube assay (QFT) has not yet been evaluated in the Thai adult population. OBJECTIVE: To evaluate the diagnostic performance and determine predictors of discordant results between the QFT and tuberculin skin test (TST). METHODS: Active tuberculosis (ATB) patients (n=54), close contacts (CCs) living in the same household as a TB patient (n=100) and healthy controls (HCs) (n=60) were interviewed and underwent the QFT and TST at Srinagarind Hospital in Thailand. Various cut-off values for the QFT (0.25-0.35 IU/mL) and TST (5-15 mm) were applied. RESULTS: The maximum agreement rate between the tests was 71.5% (κ=0.41) with cut-offs of 0.35 IU/mL and 10 mm or 0.25 IU/mL and 10 mm. Based on standard cut-off values (0.35 IU/mL and 10 mm) and using ATB patients and HCs as positive and negative controls, the TST was more sensitive than the QFT (87.0% vs. 66.7%, respectively), whereas the QFT was more specific than the TST (83.3% vs. 70.0%, respectively). Being underweight (OR 3.86, 95%CI 1.3-11.48) or overweight (OR 5.9, 95%CI 1.24-28.16) was significantly associated with TST+/QFT- results. Diabetes (OR 32.56, 95%CI 1.73-613.49) and poor or fair nutrition (OR 7.4, 95%CI 1.23-44.57) were significantly associated with TST-/QFT+ results. CONCLUSION: The TST should be used as a screening test based on its higher sensitivity, whereas the QFT should be used as a confirmatory test because of its higher specificity.