Evaluation of the QuantiFERON-TB Test.

Qiagen

Status: Completed

Conditions: Tuberculosis

Treatments: Device: CST001

Study type: Observational

Funder types: Industry

Identifiers

NCT02253537

CST001_USA5

Details and patient eligibility

About

To compare the results of the investigational test to the currently approved QuantiFERON-TB Gold In-Tube test.

Full description

To compare the sensitivity of the CST001 assay to the QuantiFERON-TB Gold assay in patients with bacteriologically confirmed and untreated TB disease.

Enrollment: 15 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical symptoms consistent with a high probability of having TB disease
• Receiving, or are likely to receive, therapy for active TB
• Confirmed tuberculosis by either AFB smear and culture testing, or Nucleic Acid Amplification methods and culture testing.
• Between 18 and 70 years of age.

Exclusion criteria

• Taken therapy for active TB or latent TB for more than 14 days
• Culture confirmation of M. tuberculosis not obtained

Trial design

15 participants in 1 patient group

Symptomatic

Description:

Patients with bacteriologically confirmed and untreated TB disease tested with CST001 assay.

Treatment:

Device: CST001