A Study to Evaluate Immunodiagnosis of Tuberculosis Infection with Flow Cytometry

Overview

About this study

The purpose of this study is to compare the diagnostic accuracy and potential predictive value of tuberculin skin test (TST) and interferon-g release assays (IGRAs) with FCA, multiplexed cytokine and chemokine profiling (MCCP), RNA transcriptional signatures (RTS) testing for latent tuberculosis infection (LTBI) in patients with and without immunosuppression.

 

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Patients and subjects 18 years or older and in stable medical condition.
  • Patients at low risk for TB infection:
    • Being born in a low-incidence TB area, and low risk for contact with TB cases (i.e., no prior work or history of staying in a potentially TB transmissible area such as inpatient hospital facility, jail or prison, or nursing home); or
    • Who also are tested for job screening purposes or prior to initiation of immunosuppressive therapy.
  • Patients at intermediate to high risk for TB infection: Recent TST or IGRA testing, or clinical indication for either TST or IGRA testing (i.e., Contacts of TB cases, foreign-born subjects without other risk factors for TB infection, patients on immunosuppressive therapy, chronic medical conditions at risk of TB infections, healthcare worker screening, etc.). We will also include patients with history of prior discordant TST and QuantiFERON TB Gold/In-Tube™ results.
  • Patient with recent diagnosis of culture-proven TB infection or on treatment for active TB, pending final culture results.
  • Signed written informed and HIPAA consent.

Exclusion Criteria:

  • Patients younger than 18 years old.
  • Patients unable to perform the study protocol.
  • Patients unwilling or unable to give written informed consent.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Patricio Escalante, M.D.

Open for enrollment

Contact information:

Thomas Cox

(507) 284-9946

Cox.Thomas@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available