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To compare the results of the investigational test to the currently approved QuantiFERON-TB Gold In-Tube test.
To compare the specificity of the CST001 assay to the QFT Gold Test in low TB exposure risk subjects and non-tuberculosis mycobacterial infections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| non TB infection | Group tested with CST_001 |
| |
| low exposure risk | Group tested with CST_001 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CST_001 | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 day (At time of enrollment) |
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Low-exposure Risk Group
Inclusion Criteria:
Exclusion Criteria:
Non-tuberculous mycobacterial infection Group
Inclusion Criteria:
Exclusion Criteria:
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Patients who have either low-exposure rist to tuberculosis or have non-tuberculous mycobacterial infections
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Winthrop, MD, M.P.H | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Sciences University | Portland | Oregon | 97239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | QuantiFERON - TB Gold Package Insert (Doc. No. US05990301L). March 2013. Cellestis Inc. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Non TB Infection | Non TB Infected Group tested with CST001 |
| FG001 | Low Exposure Risk | Low exposure Risk Group tested with CST_001 CST_001 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Non TB Infection | Non TB Infected Group tested with CST_001 CST_001 |
| BG001 | Low Exposure Risk | Low exposure Risk Group tested with CST_001 CST_001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 1 day (At time of enrollment) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Non TB Infection | Non TB Infected Group tested with CST001 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Study Coordinator | QIAGEN Sciences | 301-944-7094 | andrew.schumacher@qiagen.com |
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
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| 0 |
| 51 |
| 0 |
| 51 |
| EG001 | Low Exposure Risk | Low exposure Risk Group tested with CST001 | 0 | 212 | 0 | 212 |
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| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |