NCT04141982

Clinical Concordance Evaluation of T-SPOT®.TB Assay Performance (T-Cell SelectTM Study)

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 680 (actual)
• Sponsor: Oxford Immunotec · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Tuberculosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	T-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.

Timeline

• Start date: 2019-11-04
• Primary completion: 2020-03-18
• Completion: 2020-03-18
• First posted: 2019-10-28
• Last updated: 2022-03-03

Locations

4 sites across 2 countries: United States, South Africa