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OpenTrials
Completed

NCT Number: NCT02256839

Evaluation of the QuantiFERON-TB Test.

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

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Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Infections

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Oregon Health & Sciences University

Portland, Oregon, 97239, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CST_001

Device

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

QIAGEN Gaithersburg, Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 6, 2014
Registry last updated
Aug 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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