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Trial Outcomes & Findings for Evaluation of the QuantiFERON-TB Test. (NCT NCT02256839)

NCT ID: NCT02256839

Last Updated: 2019-08-01

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

268 participants

Primary outcome timeframe

1 day (At time of enrollment)

Results posted on

2019-08-01

Participant Flow

For the TB low risk cohort, 2 samples were excluded due to sample transport issues and the third sample for being misdiagnosed as low risk. For the non-TB cohort,1 sample was excluded due to a sample transport issue, and second excluded sample was inadvertently enrolled twice.

Participant milestones

Participant milestones
Measure
Non TB Infection
Non TB Infected Group tested with CST001
Low Exposure Risk
Low exposure Risk Group tested with CST\_001 CST\_001
Overall Study
STARTED
53
215
Overall Study
COMPLETED
51
212
Overall Study
NOT COMPLETED
2
3

Reasons for withdrawal

Reasons for withdrawal
Measure
Non TB Infection
Non TB Infected Group tested with CST001
Low Exposure Risk
Low exposure Risk Group tested with CST\_001 CST\_001
Overall Study
Did not meet Eligibility Criteria
2
3

Baseline Characteristics

Evaluation of the QuantiFERON-TB Test.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Non TB Infection
n=51 Participants
Non TB Infected Group tested with CST\_001 CST\_001
Low Exposure Risk
n=212 Participants
Low exposure Risk Group tested with CST\_001 CST\_001
Total
n=263 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
27 Participants
n=5 Participants
207 Participants
n=7 Participants
234 Participants
n=5 Participants
Age, Categorical
>=65 years
24 Participants
n=5 Participants
5 Participants
n=7 Participants
29 Participants
n=5 Participants
Sex: Female, Male
Female
12 Participants
n=5 Participants
157 Participants
n=7 Participants
169 Participants
n=5 Participants
Sex: Female, Male
Male
39 Participants
n=5 Participants
55 Participants
n=7 Participants
94 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
n=5 Participants
10 Participants
n=7 Participants
11 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
50 Participants
n=5 Participants
193 Participants
n=7 Participants
243 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
9 Participants
n=7 Participants
9 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
13 Participants
n=7 Participants
13 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
2 Participants
n=7 Participants
2 Participants
n=5 Participants
Race (NIH/OMB)
White
49 Participants
n=5 Participants
177 Participants
n=7 Participants
226 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
1 Participants
n=5 Participants
13 Participants
n=7 Participants
14 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
6 Participants
n=7 Participants
6 Participants
n=5 Participants
Region of Enrollment
United States
51 Participants
n=5 Participants
212 Participants
n=7 Participants
263 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Non TB Infection
n=51 Participants
Group tested with CST\_001 CST\_001
Low Exposure Risk
n=212 Participants
Group tested with CST\_001 CST\_001
Clinical Specificity of the CST001 Assay as Measured by the Number of Correctly Identified Actual Negatives
49 Participants
208 Participants

Adverse Events

Non TB Infection

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Low Exposure Risk

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Clinical Study Coordinator

QIAGEN Sciences

Phone: 301-944-7094

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place