Tuberculosis
Conditions
Keywords
Tuberculosis, TB
Brief summary
To compare the results of the investigational test to the currently approved QuantiFERON-TB Gold In-Tube test.
Detailed description
To compare the specificity of the CST001 assay to the QFT Gold Test in low TB exposure risk subjects and non-tuberculosis mycobacterial infections.
Interventions
DEVICECST_001
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
Yes
Inclusion criteria
Low-exposure Risk Group Inclusion Criteria: * No identified risk factors for TB infection
Exclusion criteria
* Age less than 18 years or greater than 80 years * Identified Risk Factors For TB Infection Non-tuberculous mycobacterial infection Group Inclusion Criteria: * history of nontuberculous mycobacterial disease (pulmonary or extrapulmonary) in accordance with the 2007 ATS/IDSA criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Specificity of the CST001 Assay as Measured by the Number of Correctly Identified Actual Negatives | 1 day (At time of enrollment) | To compare the clinical specificity of the CST001 assay to the QuantiFERON-TB Gold test in low TB exposure risk subjects and non TB infected subjects based on an assessment of known risk factors. These subjects had no identified risk factors of TB infection. |
Countries
United States
Participant flow
Pre-assignment details
For the TB low risk cohort, 2 samples were excluded due to sample transport issues and the third sample for being misdiagnosed as low risk. For the non-TB cohort,1 sample was excluded due to a sample transport issue, and second excluded sample was inadvertently enrolled twice.
Participants by arm
| Arm | Count |
|---|---|
| Non TB Infection Non TB Infected Group tested with CST\_001
CST\_001 | 51 |
| Low Exposure Risk Low exposure Risk Group tested with CST\_001
CST\_001 | 212 |
| Total | 263 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not meet Eligibility Criteria | 2 | 3 |
Baseline characteristics
| Characteristic | Total | Non TB Infection | Low Exposure Risk |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 29 Participants | 24 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 234 Participants | 27 Participants | 207 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 1 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 243 Participants | 50 Participants | 193 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 9 Participants | 0 Participants | 9 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 13 Participants | 0 Participants | 13 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 14 Participants | 1 Participants | 13 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 0 Participants | 6 Participants |
| Race (NIH/OMB) White | 226 Participants | 49 Participants | 177 Participants |
| Region of Enrollment United States | 263 Participants | 51 Participants | 212 Participants |
| Sex: Female, Male Female | 169 Participants | 12 Participants | 157 Participants |
| Sex: Female, Male Male | 94 Participants | 39 Participants | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 51 | 0 / 212 |
| serious Total, serious adverse events | 0 / 51 | 0 / 212 |
Outcome results
Primary
Clinical Specificity of the CST001 Assay as Measured by the Number of Correctly Identified Actual Negatives
To compare the clinical specificity of the CST001 assay to the QuantiFERON-TB Gold test in low TB exposure risk subjects and non TB infected subjects based on an assessment of known risk factors. These subjects had no identified risk factors of TB infection.
Time frame: 1 day (At time of enrollment)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Non TB Infection | Clinical Specificity of the CST001 Assay as Measured by the Number of Correctly Identified Actual Negatives | 49 Participants |
| Low Exposure Risk | Clinical Specificity of the CST001 Assay as Measured by the Number of Correctly Identified Actual Negatives | 208 Participants |
95% CI: [95.3, 99.3]
95% CI: [85.4, 99.3]