Screening for Latent Tuberculosis in Healthcare Workers With Quantiferon-Gold Assay: A Cost-Effectiveness Analysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00449345
Recruitment Status : Unknown
Verified May 2007 by Assuta Hospital Systems.
Recruitment status was:  Recruiting
First Posted : March 20, 2007
Last Update Posted : May 30, 2007
Information provided by:
Assuta Hospital Systems

Brief Summary:

The ministry of health in Israel requires all health-care workers to undergo screening for latent Tuberculosis infection (LTBI) prior to starting work. This is based on the Mantoux skin test, which is notoriously unreliable.

In recent years, more specific and sensitive tests based on interferon-gamma secretion to TB antigens have come to market, and most current evidence shows that many mantoux positive persons do not have LTBI. Quantiferon-GOLD is one of these assays.

In this prospective study, we will draw blood for the Quantiferon-GOLD assay in parallel to conventional testing, and perform a cost-effectiveness analysis of the cost of the investigation and treatment of LTBI in health-care workers.

We hypothesize that in spite of the cost of screening healthcare workers with Quantiferon-GOLD tests, the reduction in need for LTBI treatment and associated costs will render the test cost-effective.

Condition or disease Intervention/treatment
Latent Tuberculosis Infection Procedure: Blood test for Quantiferon-GOLD assay

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Prospective
Study Start Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Health care worker undergoing screening for LTBI

Exclusion Criteria:

  • Previous tuberculosis or treatment for LTBI
  • Immunosuppressed due to drug treatment, HIV, organ transplant
  • Recent TB contacts

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00449345

Contact: David Shitrit, MD +972 8 946 8617
Contact: Ben Fox, MRCP +972 8 946 8617

Community Tuberculosis service Recruiting
Rehovot, Israel
Sponsors and Collaborators
Assuta Hospital Systems
Principal Investigator: David Shitrit, MD Maccabi Healthcare Services, Israel Identifier: NCT00449345     History of Changes
Other Study ID Numbers: 2006055
First Posted: March 20, 2007    Key Record Dates
Last Update Posted: May 30, 2007
Last Verified: May 2007

Keywords provided by Assuta Hospital Systems:
Latent tuberculosis infection
Health care workers
Tuberculin skin test
Mantoux skin test
Interferon gamma
Cost effectiveness

Additional relevant MeSH terms:
Latent Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections