Tuberculosis
Conditions
Keywords
Tuberculosis, TB
Brief summary
To compare the positivity rate of the investigational assay to the currently approved QuantiFERON-TB Gold In-Tube assay.
Interventions
DEVICECST001
Sponsors
QIAGEN Gaithersburg, Inc
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Low Risk Tested with CST001
CST001 | 34 |
| Known Risk Tested with CST001
CST001 | 32 |
| Total | 66 |
Baseline characteristics
| Characteristic | Low Risk | Total | Known Risk |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 6 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 31 Participants | 60 Participants | 29 Participants |
| Age, Continuous | 52.5 years | 55.5 years | 58.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 3 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants | 61 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 29 Participants | 22 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 10 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 18 Participants | 23 Participants | 5 Participants |
| Region of Enrollment United States | 34 Participants | 66 Participants | 32 Participants |
| Sex: Female, Male Female | 11 Participants | 27 Participants | 16 Participants |
| Sex: Female, Male Male | 23 Participants | 39 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 34 | 0 / 32 |
| serious Total, serious adverse events | 0 / 34 | 0 / 32 |
Outcome results
Primary
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low Risk | Number of Participants With Concordant CST001 Assay Results for All Replicates Across Three Testing Sites | 32 Participants |
| Known Risk | Number of Participants With Concordant CST001 Assay Results for All Replicates Across Three Testing Sites | 23 Participants |
95% CI: [72.13, 91.38]