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

QIAGEN Gaithersburg, Inc66 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Tuberculosis

Interventions

CST001DEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

VA Palo Alto Health Care System (VAPAHCS)

Palo Alto, California, United States

Outcomes

Primary Outcomes

Number of Participants With Concordant CST001 Assay Results for All Replicates Across Three Testing Sites

To demonstrate the reproducibility of the CST001 assay between 3 external laboratories with 2 operators per site.

Time frame: 1 day (At time of enrollment)

Data from ClinicalTrials.gov

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