Tuberculosis
Conditions
Brief summary
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
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.
Interventions
DIAGNOSTIC_TESTT-Cell SelectTM Kit
The T-Cell Select kit is intended for the isolation of mononuclear immune cells from whole blood, using positive selection via a magnetic bead-based cell separation system, for use in the T-SPOT.TB assay.
Sponsors
Oxford Immunotec
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Subjects presenting at sites enrolling suspected of having TB infection 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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Achieving positive and negative clinical concordance between results of the T-SPOT.TB assay between 0-55hours after venipuncture | 1 year | Achieving 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 |
Countries
South Africa, United States
Outcome results
None listed