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

Completed

• Conditions: Tuberculosis

• Registration Number: NCT02687529
• Lead Sponsor: QIAGEN Gaithersburg, Inc

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-27
• Primary Completion: 2015-11-07
• Study First Submitted: 2016-02-16
• Study First Submitted QC: 2016-02-19
• Study First Posted: 2016-02-22
• Study Completion: 2016-05-26
• Results First Submitted: 2018-09-18
• Results First Submitted QC: 2019-02-27
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-05
• Results First Posted: 2019-06-06
• Last Update Posted: 2019-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants With Concordant CST001 Assay Results for All Replicates Across Three Testing Sites	1 day (At time of enrollment)	To demonstrate the reproducibility of the CST001 assay between 3 external laboratories with 2 operators per site.

Trial Locations

Locations (1)

VA Palo Alto Health Care System (VAPAHCS); 🇺🇸 Palo Alto, California, United States