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

Completed

Conditions studied: Tuberculosis

In brief

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

Key facts

Study ID: NCT04141982
Run by: Oxford Immunotec
People needed: 680
Starts: 2019-11-04
Expected to finish: 2020-03-18
Last updated by the study team: 2022-03-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

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

Where it is running

NECCR Primacare Research, LLC — Fall River, Massachusetts, United States
Ohio State University — Columbus, Ohio, 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

Full record on ClinicalTrials.gov

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