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

Completed

• Conditions: Tuberculosis
• Interventions: Diagnostic Test: T-Cell SelectTM Kit

• Registration Number: NCT04141982
• Lead Sponsor: Oxford Immunotec

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.

Study Timeline

• Study First Submitted: 2019-10-25
• Study First Submitted QC: 2019-10-25
• Study First Posted: 2019-10-28
• Study Start: 2019-11-04
• Primary Completion: 2020-03-18
• Study Completion: 2020-03-18
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-02
• Last Update Posted: 2022-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 680

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Suspected of having TB infection	T-Cell SelectTM Kit	These donors are suspected of having TB infection and live in a high endemic area for TB infection
No (or minimal) TB risk factors	T-Cell SelectTM Kit	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	T-Cell SelectTM Kit	These donors must live in an low/intermediate endemic area for TB infection

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

NECCR Primacare Research, LLC; 🇺🇸 Fall River, Massachusetts, United States

University of Texas Health Science Center at Houston, School of Public Health in Brownsville; 🇺🇸 Brownsville, Texas, United States

Rapitrade; 🇿🇦 Cape Town, South Africa

Ohio State University; 🇺🇸 Columbus, Ohio, United States