Diagnostic accuracy study of STANDARD TB-Feron FIA and STANDARD TB-Feron ELISA tests for tuberculosis infection diagnosis in Eastern European setting.

Introduction: Tuberculosis infection (TBI) is diagnosed based on a positive immune response to antigens. This study aimed to evaluate both the qualitative and quantitative performance of two novel IGRA-based tests, the STANDARD E TB-Feron ELISA (TB-Feron-ELISA) and the STANDARD F TB-Feron FIA (IFN-γ) (TB-Feron-FIA), and compare their results to those of QuantiFERON-TB Gold Plus (QuantiFERON).

Methods: At Chiril Draganiuc Phthisiopneumology Institute in the Republic of Moldova, we prospectively enrolled three cohorts of adults: healthy individuals with no known close contact with TB, patients with active tuberculosis (TB), and individuals with a history of TB.