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

This study has been completed.
Oxford Immunotec
Information provided by:
University Health Network, Toronto Identifier:
First received: August 22, 2005
Last updated: December 22, 2010
Last verified: July 2005

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.

Condition Intervention Phase
Tuberculosis Other: T-SPOT TB ELISPOT test Phase 3

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Comparison of Traditional Tuberculosis Screening Methods With the T-SPOT TB Test for the Diagnosis of Latent Tuberculosis Infection in Immunocompromised Populations

Resource links provided by NLM:

Further study details as provided by University Health Network, Toronto:

Enrollment: 203
Study Start Date: January 2005
Study Completion Date: April 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: T-SPOT TB ELISPOT test
    ELISPOT test for detecting T cell responses to tuberculosis antigens.
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with endstage renal disease

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00134342

Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
University Health Network
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University Health Network, Toronto
Oxford Immunotec
Principal Investigator: Michael Gardam, MD University Health Network, University of Toronto
  More Information

Responsible Party: Nial Ferguson, Oxford Immunotec Identifier: NCT00134342     History of Changes
Other Study ID Numbers: 04-0702-AE
Study First Received: August 22, 2005
Last Updated: December 22, 2010

Keywords provided by University Health Network, Toronto:
tuberculin test
immunologic tests
Latent tuberculosis
end stage renal disease
solid organ transplantation
bone marrow transplantation
rheumatologic disease

Additional relevant MeSH terms:
Latent Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections processed this record on September 21, 2017