This study will evaluate the performance of the VIDAS® Interferon Gamma (IFN-γ) Release Assay (TB-IGRA) assay, which is intended for use as an aid in the diagnosis of tuberculosis infection. This study is designed to assess (1) the sensitivity of this assay, (2) its percent agreement with other diagnostic tests, (3) its measurement precision , and (4) any potential interference of the presence of other non-tuberculosis mycobacterial bacterial infections with this assay.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Positive, negative, indeterminate for tuberculosis
Timeframe: One-time measurement through study completion for each participant, an average of 5 months.
Sensitivity and positive and negative percent agreement for the VIDAS TB IGRA assay with comparator assay
Timeframe: One-time measurement through study completion for each participant, an average of 5 months.
Degree of Interference by nontuberculous mycobacteria for the VIDAS TB IGRA assay
Timeframe: One-time measurement through study completion for each participant, an average of 5 months.
Measurement Precision of the VIDAS TB IGRA assay results
Timeframe: Triplicate measurement per sample through study completion, an average of 5 months.