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

NCT04141982 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 680

Last updated 2022-03-03

No results posted yet for this study

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • Oxford Immunotec

    lead INDUSTRY

Principal Investigators

  • Andre Trollip, PhD · Rapitrade

  • Blanca Restrepo, PhD · The University of Texas Health Science Center, Houston

  • Ehab Sorial, MD · NECCR Primacare Research, LLC

  • Shu-Hua Wang, MD · Ohio State University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-04
Primary Completion
2020-03-18
Completion
2020-03-18

Countries

  • United States
  • South Africa

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04141982 on ClinicalTrials.gov