N/A
N=66
Evaluation of the 4th Generation QuantiFERON-TB Test (QFT-Plus) for the Detection of Tuberculosis Infection
Tuberculosis
Bottom Line
View on ClinicalTrials.gov: NCT02687529 ↗Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: Number of Participants With Concordant CST001 Assay Results for All Replicates Across Three Testing Sites — 32; 23 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- CST001 (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- QIAGEN Gaithersburg, Inc
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Concordant CST001 Assay Results for All Replicates Across Three Testing Sites |
32; 23 | — |
Summary
To compare the positivity rate of the investigational assay to the currently approved QuantiFERON-TB Gold In-Tube assay.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02687529). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.