Performance evaluation of the VIDAS® TB-IGRA assay – Clinical Trial 2 Active TB Study

Principal Investigator: Jose Cadena Zuluaga, MD 

Conditions: Active Tuberculosis 

Purpose

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.

Eligibility Criteria

Inclusion Criteria:

  1. A person classified as or suspected of having M. tuberculosis disease (active TB):
  2. A person with known HIV status, determined by a laboratory or rapid test performed no earlier than one month prior to, or at the time of inclusion into this study A person of age ≥ 2 years

Exclusion Criteria:

  1. A person who has been on an anti-TB treatment for >15 days for the ongoing infection Pregnant women A person who has received an anti-tumor necrosis factor (TNF) alpha treatment within the previous 3 months A person who has had prior TST A person with an NTM infection A person with positive HIV status.