Tuberculosis (TB) Screening for the Diagnosis of Latent TB in Immunocompromised Populations

A Comparison of Traditional Tuberculosis Screening Methods With the T-SPOT TB Test for the Diagnosis of Latent Tuberculosis Infection in Immunocompromised Populations

The tuberculin skin test (TST) has been the gold standard for diagnosing latent tuberculosis for almost 100 years. While this test performs reasonably well in healthy, non-bacille Calmette-Guerin (BCG) vaccinated populations, it is believed to perform less well in patients who do not have intact cellular immune systems (immunocompromised).

The investigators hypothesize that a new test, the T-SPOT TB ELISPOT test will provide a more accurate measurement of latent infection in immunocompromised people. This study will compare the TST to the T-SPOT TB ELISPOT test, and to the results of an expert physician diagnostic panel.

Study Overview

• Status: Completed
• Conditions: Tuberculosis
• Intervention / Treatment: Other: T-SPOT TB ELISPOT test

Detailed Description

Main Study Question:

We propose to investigate the correlation between the traditional TST-based method of screening for latent tuberculosis infection in specific immunocompromised populations as recommended by Canadian and American standards: the T-SPOT TB ELISPOT test: and an expert tuberculosis physician panel incorporating the Mantoux test, a risk factor survey, and a chest radiograph.

Secondary Study Question:

In a subset of patients who have tested positive on both the Mantoux and T-SPOT ELISPOT tests prior to undergoing additional immune suppression i.e., patients pre-bone marrow transplant and rheumatology patients pre-receipt of anti-TNF alpha therapy or high dose corticosteroids, we propose to repeat the T-SPOT ELISPOT and Mantoux after immune suppression to assess the development of cutaneous anergy.

• Study Type: Observational
• Enrollment (Actual): 203

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X5
      • Mount Sinai Hospital
    • Toronto, Ontario, Canada, M5G 2C4
      • University Health Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with endstage renal disease

Description

Inclusion Criteria:

Inclusion criteria for the study are broad.

• Participants can be enrolled regardless of race, gender, risk of exposure to TB, metabolic disorders or coinfection with non-TB agents.
• Only participants who have provided written informed consent will be included.

• Patients belonging to the four following groups will be considered eligible for tuberculosis screening and inclusion in the T-SPOT ELISPOT study:

  • Patients with end stage renal disease receiving hemodialysis or peritoneal dialysis;
  • Recipients of solid organ transplants;
  • Recipients of, or candidates for, an allogeneic stem cell transplant for hematologic malignancies;
  • Patients with rheumatologic diseases (e.g., systemic lupus erythematosus [SLE], rheumatoid arthritis, psoriasis) who are receiving, or about to receive, immunosuppressive therapy, including corticosteroids and anti-TNF alpha inhibitors.

Exclusion Criteria:

• Individuals who have not signed an informed consent
• Hemophiliacs or individuals who, on the advice of the enrolling physician, may otherwise be at increased risk of an adverse reaction to venipuncture or tuberculin skin test administration

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: Oxford Immunotec
• Investigators: Principal Investigator: Michael Gardam, MD, University Health Network, University of Toronto

Study record dates

Study Major Dates

• Study Start: January 1, 2005
• Primary Completion (Actual): April 1, 2005
• Study Completion (Actual): April 1, 2005

Study Registration Dates

• First Submitted: August 22, 2005
• First Submitted That Met QC Criteria: August 23, 2005
• First Posted (Estimate): August 24, 2005

Study Record Updates

• Last Update Posted (Estimate): December 23, 2010
• Last Update Submitted That Met QC Criteria: December 22, 2010
• Last Verified: July 1, 2005

More Information

Terms related to this study

• Keywords: tuberculosis; bone marrow transplantation; solid organ transplantation; Latent tuberculosis; end stage renal disease; tuberculin test; immunologic tests; rheumatologic disease
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Latent Infection; Tuberculosis; Latent Tuberculosis
• Other Study ID Numbers: 04-0702-AE