---
title: Evaluation of the QuantiFERON-TB Test.
nct_id: NCT02256839
overall_status: COMPLETED
sponsor: QIAGEN Gaithersburg, Inc
study_type: OBSERVATIONAL
primary_condition: Tuberculosis
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02256839.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02256839"
ct_last_update_post_date: 2019-08-01
last_seen_at: "2026-05-12T07:13:48.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Evaluation of the QuantiFERON-TB Test.

**Official Title:** Evaluation of the 4th Generation QuantiFERON-TB Gold Test (CST001) for the Detection of Tuberculosis Infection

**NCT ID:** [NCT02256839](https://clinicaltrials.gov/study/NCT02256839)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 268
- **Lead Sponsor:** QIAGEN Gaithersburg, Inc
- **Conditions:** Tuberculosis
- **Start Date:** 2014-10
- **Completion Date:** 2015-10
- **CT.gov Last Update:** 2019-08-01

## Brief Summary

To compare the results of the investigational test to the currently approved QuantiFERON-TB Gold In-Tube test.

## Detailed Description

To compare the specificity of the CST001 assay to the QFT Gold Test in low TB exposure risk subjects and non-tuberculosis mycobacterial infections.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 80 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Low-exposure Risk Group

Inclusion Criteria:

* No identified risk factors for TB infection

Exclusion Criteria:

* Age less than 18 years or greater than 80 years
* Identified Risk Factors For TB Infection

Non-tuberculous mycobacterial infection Group

Inclusion Criteria:

* history of nontuberculous mycobacterial disease (pulmonary or extrapulmonary) in accordance with the 2007 ATS/IDSA criteria

Exclusion Criteria:

* Age less than 18 years or greater than 80 years
* Identified Risk Factors For TB Infection
```

## Arms

- **non TB infection** — Group tested with CST\_001
- **low exposure risk** — Group tested with CST\_001

## Interventions

- **CST_001** (DEVICE)

## Primary Outcomes

- **Clinical Specificity of the CST001 Assay as Measured by the Number of Correctly Identified Actual Negatives** _(time frame: 1 day (At time of enrollment))_ — To compare the clinical specificity of the CST001 assay to the QuantiFERON-TB Gold test in low TB exposure risk subjects and non TB infected subjects based on an assessment of known risk factors. These subjects had no identified risk factors of TB infection.

## Locations (1)

- Oregon Health & Sciences University, Portland, Oregon, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.oregon health & sciences university|portland|oregon|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02256839.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02256839*  
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