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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 exclusion criteria: Cohort 2A and 2B - Negative T-SPOT.TB test - Previous or pre-existing confirmed TB diagnosis - On anti-TB treatment - Symptoms of active TB - Not meeting inclusion criteria

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Test Arm 1- T-SPOT.TB assay Test Arm 1: T-SPOT.TB test using density gradient isolation (Leucosep) For each subject recruited in the study, cells will be isolated using Leucosep Tubes and T-Cell Xtend reagent according to package insert. For each subject recruited in the study, the T-SPOT.TB assay will be run according to the assay package insert.
Test Arm 2-QuantiFERON-TB Gold Plus assay Test Arm 2: QuantiFERON-TB Gold Plus For each subject recruited in the study, the QuantiFERON-TB Gold Plus (QFT-Plus) assay will be run according to the assay package insert.

More Details

Status
Completed
Sponsor
Oxford Immunotec

Study Contact

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

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.