N/A
Completed N=268
Evaluation of the QuantiFERON-TB Test.
Source: ClinicalTrials.gov NCT02256839 ↗Enrolled (actual)
268
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcomePrimary: Clinical Specificity of the CST001 Assay as Measured by the Number of Correctly Identified Actual Negatives — 49; 208 Participants
Summary
To compare the results of the investigational test to the currently approved QuantiFERON-TB Gold In-Tube test.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Specificity of the CST001 Assay as Measured by the Number of Correctly Identified Actual Negatives |
49; 208 | — |
Eligibility 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
Exclusion Criteria
- Age less than 18 years or greater than 80 years
- Identified Risk Factors For TB Infection
Data sourced from ClinicalTrials.gov (NCT02256839). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.