Tuberculosis Clinical Trial
Official title:
Clinical Concordance Evaluation of the T-SPOT®.TB Assay Performance Using Positive Selection With the T-Cell SelectTM Kit and Density Gradient Cell Isolation Methods
Verified date | March 2022 |
Source | Oxford Immunotec |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
Status | Completed |
Enrollment | 680 |
Est. completion date | March 18, 2020 |
Est. primary completion date | March 18, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 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 |
Country | Name | City | State |
---|---|---|---|
South Africa | Rapitrade | Cape Town | |
United States | University of Texas Health Science Center at Houston, School of Public Health in Brownsville | Brownsville | Texas |
United States | Ohio State University | Columbus | Ohio |
United States | NECCR Primacare Research, LLC | Fall River | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Oxford Immunotec |
United States, South Africa,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Achieving positive and negative clinical concordance between results of the T-SPOT.TB assay between 0-55hours after venipuncture | 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 | 1 year |
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