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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00402402

Enrollment

300

Registered

2006-11-22

Start date

2006-10-31

Completion date

2007-07-31

Last updated

2008-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Liver Disease, Liver Transplantation, Tuberculosis

Keywords

Tuberculin skin test, Quantiferon-TB Gold assay, Chronic liver disease, Liver transplantation, Latent tuberculosis infection

Brief summary

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

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.

Interventions

PROCEDURETuberculin skin test

PROCEDUREQuantiferon-TB Gold assay

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	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

Measure	Time frame
Factors associated with discordance between the TST and the QFT-G test	—
Frequency of anergy in this patient population	—

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026