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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Comparison of Quantiferon-TB Gold Assay With Tuberculin Skin Testing for Detecting Latent Mycobacterium Tuberculosis Infection in Patients With Chronic Liver Disease Awaiting Liver Transplantation

Conditions
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Chronic Liver Disease, Liver Transplantation, Tuberculosis

Intervention / Treatment
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* Procedure: Tuberculin skin test
* Procedure: Quantiferon-TB Gold assay


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Tuberculin skin test|nan|
|Procedure: Quantiferon-TB Gold assay|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concordance between the Quantiferon-TB Gold assay and the tuberculin skin test |  |  | 
| Correlation of the test results to the patient's risk of latent TB infection |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Factors associated with discordance between the TST and the QFT-G test |  |  | 
| Frequency of anergy in this patient population |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tuberculin skin test, Quantiferon-TB Gold assay, Chronic liver disease, Liver transplantation, Latent tuberculosis infection