A Study to Evaluate the QuantiFERON-TB Gold-Plus Test for Blood Detection of Tuberculosis without Symptoms

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 16-008398
    Sponsor Protocol Number: 16-008398

About this study

The purpose of this study is to evaluate the new QFT-Plus assay compared to the QFT-Gold assay and the tuberculin skin test results (as available) for the detection of tuberculosis without symptoms in high-risk patients.

               

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. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

 

Inclusion Criteria

  • A prior diagnosis of Latent Tuberculosis Infection
  • Age ≥ 18 years
  • Undergoing routine screening or follow-up care for active tuberculosis or any form of Latent Tuberculosis
  • Any patient, including those with refugee or immigrant status, receiving medical care at Olmsted Public Health Services

Exclusion Criteria

  • Lack of oral consent
  • No known or suspected active tuberculosis disease

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Elitza Theel, Ph.D.

Contact us for the latest status

Contact information:

John Wilson M.D.

(507)255-3961

wilson.john@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20301671

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