Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Suspected of having TB infection These donors are suspected of having TB infection and live in a high endemic area for TB infection
  • 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.
No (or minimal) TB risk factors These donors must have no previous medical record of TB infection and live in low endemic area for TB infection
  • 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.
low/intermediate risk of TB infection population These donors must live in an low/intermediate endemic area for TB infection
  • 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.

More Details

Status
Completed
Sponsor
Oxford Immunotec

Study Contact

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.