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OpenTrials
Completed

NCT Number: NCT02253537

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–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Washington

Seattle, Washington, 98195, United States

About this study

To compare the sensitivity of the CST001 assay to the QuantiFERON-TB Gold assay in patients with bacteriologically confirmed and untreated TB disease.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinical symptoms consistent with a high probability of having TB disease
  • Receiving, or are likely to receive, therapy for active TB
  • Confirmed tuberculosis by either AFB smear and culture testing, or Nucleic Acid Amplification methods and culture testing.
  • Between 18 and 70 years of age.

Exclusion criteria

  • Taken therapy for active TB or latent TB for more than 14 days
  • Culture confirmation of M. tuberculosis not obtained

Treatment and study plan

CST001

Device

Primary outcomes

  1. Number of Participants With Clinical Signs/Symptoms Indicating TB With a Positive CST001 Assay Result as an Indication of Clinical Sensitivity

    Time frame: At time of enrollment

    Subjects who have clinical signs/symptoms indicating TB and who are receiving or have to start the treatment for active TB were tested. Subjects who were presenting with symptoms suggestive of TB disease and who have a positive acid-fast bacillus (AFB) smear or have Mycobacterium tuberculosis (MTB) in a specimen detected by nucleic acid amplification (NAA) or MTB complex Polymerase Chain Reaction (PCR), and who have received treatment for no more than 14 days upon enrollment.

Sponsors and collaborators

Lead sponsor

QIAGEN Gaithersburg, Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 1, 2014
Registry last updated
Jun 18, 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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