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

Q

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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