Prospective Comparison of the Tuberculin Skin Test and Interferon-Gamma Release Assays in Diagnosing Infection With Mycobacterium Tuberculosis and in Predicting Progression to Tuberculosis

1. Study participants must be at high risk for latent tuberculosis infection or at high
risk for progression to tuberculosis disease, including being a:

• Close contact of a person with pulmonary tuberculosis who is part of a current
contact investigation and the index/source case meets the following criteria:

1. Culture-positive, OR

2. Culture-negative and smear positive and nucleic acid amplification test-positive.

Participants may be enrolled before the culture results for the index/source case are
available. If the criteria described above are not met once results are available, the
participant will be terminated from the study and any collected data will be
immediately destroyed.

A close contact is defined as spending 15 or more hours over a week's period in a
shared airspace with a person with active pulmonary tuberculosis while that person was
presumed to be infectious.

- Foreign-born person from a high risk country.

- Foreign-born person from a medium risk country who moved to the United States
within the past 5 years.

- Person who has spent at least 30 days in total in a high risk country within the
last 5 years.

- Person belonging to a population with a prevalence of latent tuberculosis
infection ≥ 25% as demonstrated by local surveys. These populations will vary by
site; examples include Mexican immigrants in San Diego, California or homeless
drug users in Baltimore, Maryland.

- HIV-positive person.

2. Study participants (or a parent/guardian, if applicable) must be willing and able to
provide informed consent.

4.2 Subject Exclusion Criteria

Subjects meeting any of the exclusion criteria will be excluded from study enrollment.

1. People with known current active tuberculosis.

2. People with a previous anaphylactic reaction to tuberculin.

3. Persons currently being treated for latent tuberculosis infection.

4. Persons anticipating or scheduled to permanently leave the United States (e.g.,
tourists, visiting scholars, exchange students) in less than 2 years from the time of
proposed study enrollment.

5. Foster children.