Assessing the Ability of the T-SPOT®.TB Test (IQ)

Assessing the Ability of the T-SPOT®.TB Test to Identify Those at Risk of Active Mycobacterium Tuberculosis Infection Using the Normalized Tuberculosis (TB) Specific Lymphocyte Response.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03973970

Acronym

Enrollment

201

Registered

2019-06-04

Start date

2019-09-23

Completion date

2020-06-30

Last updated

2021-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis

Keywords

Brief summary

The primary objective of this clinical research study is to demonstrate performance of the normalized TB specific lymphocyte response (NTBSLR) in identifying patients with active TB disease. The secondary exploratory objective is to demonstrate that active TB cannot be identified using an antigen-to-mitogen ratio derived from an ELISA-based IGRA.

Detailed description

This study will enroll up to 202 subjects (assumes 15 % exclusion/drop-out rate). The target number of subjects is 75 active TB (recruited from subjects presenting at TB clinics) and 100 active TB excluded (recruited from subjects in the community). All subjects enrolled in this study will be men or women, aged 18 years or older. Duration: 1 year

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Subject Inclusion Criteria: Cohort 1A and 1B * Must be at least 18 years of age * Must be able to provide informed consent * Must be able to provide a minimum of 10 mL of whole blood at each visit * Must be T-SPOT.TB positive * First visit suspect TB subjects with no prior history of TB diagnosis Subject

Exclusion criteria

Cohort 1A and 1B * Negative in the T-SPOT.TB test * Previous or pre-existing confirmed TB diagnosis * On anti-TB treatment for less than 1 week\* * Not meeting inclusion criteria Subject inclusion criteria: Cohort 2A and 2B * Must be at least 18 years of age * Must be able to provide informed consent * Must be able to provide a minimum of 10 mL of whole blood at each visit * Must be T-SPOT.TB positive * No prior history of TB diagnosis Subject

Design outcomes

Primary

Measure	Time frame	Description
NTBSLR	2 year	The primary objective of this study is to demonstrate performance of the normalized Tuberculosis (TB) specific lymphocyte response (NTBSLR) in identifying patients with active Tuberculosis (TB) disease.

Secondary

Measure	Time frame	Description
IGRA	2 year	The secondary exploratory objective is to demonstrate that active Tuberculosis (TB) cannot be identified using an antigen-to-mitogen ratio derived from an ELISA-based Interferon-Gamma Release Assay (IGRA).

Countries

United States

Outcome results