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

Oxford Immunotec

Status: Completed

Conditions: Tuberculosis

Treatments: Diagnostic Test: T-Cell SelectTM Kit

Study type: Observational

Funder types: Industry

Identifiers

NCT04141982

OI-18-01-IP-0001

Details and patient eligibility

About

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

Full 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.

Enrollment: 680 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Subjects presenting at sites enrolling "suspected of having TB infection" 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 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

Trial design

680 participants in 3 patient groups

Suspected of having TB infection

Description:

These donors are suspected of having TB infection and live in a high endemic area for TB infection

Treatment:

Diagnostic Test: T-Cell SelectTM Kit

No (or minimal) TB risk factors

Description:

These donors must have no previous medical record of TB infection and live in low endemic area for TB infection

Treatment:

Diagnostic Test: T-Cell SelectTM Kit

low/intermediate risk of TB infection population

Description:

These donors must live in an low/intermediate endemic area for TB infection

Treatment:

Diagnostic Test: T-Cell SelectTM Kit