Evaluation of the 4th Generation QuantiFERON-TB Test (QFT-Plus) for the Detection of Tuberculosis Infection

Qiagen

Status: Completed

Conditions: Tuberculosis

Treatments: Device: CST001

Study type: Observational

Funder types: Industry

Identifiers

NCT02687529

CST001_USA7

Details and patient eligibility

About

To compare the positivity rate of the investigational assay to the currently approved QuantiFERON-TB Gold In-Tube assay.

Enrollment: 66 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Low Risk and Known Risk Cohorts

Inclusion Criteria:

• Compensated and uncompensated members (current or future) of the Department of Veterans Affairs with no identified symptoms of active TB disease
• Age greater than 18 years or less than 80 years.

Exclusion Criteria:

• Currently taking therapy for active tuberculosis or latent TB infection for more than 14 days.

Trial design

66 participants in 2 patient groups

Low Risk

Description:

Tested with CST001

Treatment:

Device: CST001

Known Risk

Description:

Tested with CST001

Treatment:

Device: CST001