Evaluation of the QuantiFERON-TB Test.

Tuberculosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02253537
• Other study ID #: CST001_USA5
• Status: Completed
• Start date: February 2, 2015
• Est. completion date: April 26, 2016

Study information

• Verified date: June 2019
• Source: QIAGEN Gaithersburg, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 26, 2016
• Est. primary completion date: April 26, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Tuberculosis

Intervention

Device:
• CST001

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
QIAGEN Gaithersburg, Inc

Country where clinical trial is conducted

United States, 

References & Publications (1)

QuantiFERON - TB Gold Package Insert (Doc. No. US05990301L). March 2013. Cellestis Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Clinical Signs/Symptoms Indicating TB With a Positive CST001 Assay Result as an Indication of Clinical Sensitivity	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.	At time of enrollment