Clinical Concordance Evaluation of T-SPOT®.TB Assay Performance (T-Cell SelectTM Study)
Purpose
The objective is to achieve 90% overall, positive and negative clinical concordance between results of the T-SPOT.TB assay, using cells isolated via density gradient centrifugation and positive selection using the T-Cell Select kit, between 0-55 hours following venepuncture
Condition
- Tuberculosis
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Be able to provide informed consent - Be able to provide a minimum of 7 mL and maximum of 20 mL of whole blood. - Have suspected TB infection. - Be at least 18 years of age. - Live in a high endemic area for TB infection
Exclusion Criteria
• Unable to meet inclusion criteria Subjects presenting at sites enrolling "no (or minimal) TB risk factors" population Inclusion Criteria - Be able to provide informed consent - Be able to provide a minimum of 7 mL and maximum of 20 mL of whole blood. - Have no suspicion TB infection. - Be at least 18 years of age. - Live in low endemic area for TB infection - Have no previous medical record of TB infection Exclusion Criteria - Unable to meet inclusion criteria - Current/previous TB diagnosis Subjects presenting at sites enrolling "low/intermediate TB risk factors" population Inclusion Criteria - Be able to provide a minimum of 7 mL and maximum of 20 mL of whole blood. - Have no suspicion TB infection. - Be at least 18 years of age. - Live in an low/intermediate endemic area for TB infection Exclusion Criteria - Unable to meet inclusion criteria
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Suspected of having TB infection | These donors are suspected of having TB infection and live in a high endemic area for TB infection |
|
No (or minimal) TB risk factors | These donors must have no previous medical record of TB infection and live in low endemic area for TB infection |
|
low/intermediate risk of TB infection population | These donors must live in an low/intermediate endemic area for TB infection |
|
More Details
- Status
- Completed
- Sponsor
- Oxford Immunotec
Study Contact
Detailed Description
In this study, clinical concordance between results of the T-SPOT.TB assay, using cells stored for 0-8 hours post venepuncture and isolated via density gradient separation and positive selection with magnetic bead isolation using the T-Cell SelectTM Kit will be assessed. Concordance between results of the T-SPOT.TB assay at 0-8 hours post venepuncture and using cells isolated with density gradient centrifugation and results obtained from cells isolated using the T-Cell Select Kit, following storage between 0-55 hours post venepuncture, will be assessed.