QuantiFERON Access Clinical Performance Study Protocol

NCT ID: NCT04243031

Last Updated: 2020-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-01

Study Completion Date

2020-11-01

Brief Summary

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Approximately 225 samples, obtained from participants with varying risk factors for TB infection and disease, will be tested using the QFT Access Kit and the comparator device QFT-Plus.

Detailed Description

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Conditions

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Tuberculosis (TB)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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All subjects

Those with TB and those without TB.

QFT Access

Intervention Type DEVICE

Measure of Interferon Gamma

Interventions

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QFT Access

Measure of Interferon Gamma

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 1\. Be ≥ 18 years of age,
* 2\. Have received no TB treatment or received treatment for less than 14 consecutive days.
* 3\. Provide Informed Consent.

* 2\. Blood handling was not completed using QFT-Plus
* 3\. Incubation was \<16 and \>24 hours
* 4\. Improperly collected and/or stored samples per Instructions For Use
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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QIAGEN Gaithersburg, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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TMF-17-1056-1

Identifier Type: -

Identifier Source: org_study_id

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