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To compare the positivity rate of the investigational assay to the currently approved QuantiFERON-TB Gold In-Tube assay.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Risk | Tested with CST001 |
| |
| Known Risk | Tested with CST001 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CST001 | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 day (At time of enrollment) |
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Low Risk and Known Risk Cohorts
Inclusion Criteria:
Exclusion Criteria:
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Patients who have either a low risk or known risk for TB exposure.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Palo Alto Health Care System (VAPAHCS) | Palo Alto | California | 94304 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | QuantiFERON-TB Gold Package Insert (DOC. No. US05990301L). March 2013. QIAGEN Inc. | ||
| 15265931 | Background | Shams H, Klucar P, Weis SE, Lalvani A, Moonan PK, Safi H, Wizel B, Ewer K, Nepom GT, Lewinsohn DM, Andersen P, Barnes PF. Characterization of a Mycobacterium tuberculosis peptide that is recognized by human CD4+ and CD8+ T cells in the context of multiple HLA alleles. J Immunol. 2004 Aug 1;173(3):1966-77. doi: 10.4049/jimmunol.173.3.1966. | |
| 17892322 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Risk | Tested with CST001 CST001 |
| FG001 | Known Risk | Tested with CST001 CST001 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Risk | Tested with CST001 CST001 |
| BG001 | Known Risk | Tested with CST001 CST001 |
| 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 | 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. | Posted | Count of Participants | Participants | 1 day (At time of enrollment) |
|
|
1 day
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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 | Low Risk | Tested with CST001 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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| Background |
| Lewinsohn DA, Winata E, Swarbrick GM, Tanner KE, Cook MS, Null MD, Cansler ME, Sette A, Sidney J, Lewinsohn DM. Immunodominant tuberculosis CD8 antigens preferentially restricted by HLA-B. PLoS Pathog. 2007 Sep 21;3(9):1240-9. doi: 10.1371/journal.ppat.0030127. |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| 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 |
|
| Participants |
|
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| EG001 | Known Risk | Tested with CST001 CST001 | 0 | 32 | 0 | 32 |
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| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |