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Comparison of Quantiferon-TB Gold Assay With Tuberculin Skin Testing in Patients With Chronic Liver Disease

University Health Network, Toronto logo

University Health Network, Toronto

Status and phase

Completed
Phase 4

Conditions

Liver Transplantation
Tuberculosis
Chronic Liver Disease

Treatments

Procedure: Quantiferon-TB Gold assay
Procedure: Tuberculin skin test

Study type

Interventional

Funder types

Other

Identifiers

NCT00402402
06-0648-AE

Details and patient eligibility

About

The purpose of the study is to estimate the usefulness of the QuantiFERON®-TB Gold test for the diagnosis of latent tuberculosis infection in liver transplant candidates by correlating the test results with risk factors for LTBI

Full description

Tuberculosis (TB) is an important cause of morbidity and mortality in organ transplant recipients. Although the tuberculin skin test (TST) is recommended for screening of latent tuberculosis infection (LTBI) in all candidates for liver transplantation, the performance of the TST in this setting is less than optimal, due to a lack of specificity and a lack of sensitivity in a population that is relatively immunocompromised. Recently, a new test named QuantiFERON-TB Gold (QFT-G) has been approved for the diagnosis of LTBI. QFT-G is expected to be more specific than TST. However, there are no studies defining the performance of QFT-G in a population of patients on a waiting list for liver transplantation. We plan to estimate the usefulness of the QFT-G test for the diagnosis of LTBI in a cohort of patients with end-stage liver disease. We hypothesize that the QFT-G test will correlate better with the risk of LTBI.

Enrollment

300 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Chronic liver disease on the waiting list or being wait listed for liver transplantation

Exclusion criteria

  • Unable to provide informed consent

    • Previous history of immediate hypersensitivity to TST
    • Previous severe local ulceration with TST
    • Suspected active TB

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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