Evaluation of the QuantiFERON-TB Test.

Qiagen

Status: Completed

Conditions: Tuberculosis

Treatments: Device: CST001

Study type: Observational

Funder types: Industry

Identifiers

NCT02142894

CST001_USA1

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

The objective of the study was to enroll patients who have clinical signs/symptoms strongly indicating TB and who are receiving of have to start the treatment for active TB, and test the variants of the CST001 assay to support the evaluation of clinical sensitivity.

Enrollment: 33 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

33 participants in 1 patient group

Symptomatic

Description:

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

Treatment:

Device: CST001