Study Stopped
Business Decision
QuantiFERON Access Clinical Performance Study Protocol
A Non-interventional, Prospective Clinical Performance Study of the QuantiFERON Access Kit to Demonstrate Clinical Accuracy Compared to a CE-marked In-Vitro Diagnostic Medical Device, in Participants With Varying Risk Factors for TB Infection and Disease.
1 other identifier
observational
N/A
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2020
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 23, 2020
CompletedFirst Posted
Study publicly available on registry
January 27, 2020
CompletedStudy Start
First participant enrolled
April 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2020
CompletedSeptember 16, 2020
September 1, 2020
4 months
January 23, 2020
September 14, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
TB Result
QFT Access result compared to the QFT-Plus result (positive, negative)
At time of enrollment
Study Arms (1)
All subjects
Those with TB and those without TB.
Interventions
Eligibility Criteria
Participants coming to clinic
You may qualify if:
- \. Be ≥ 18 years of age,
- \. Have received no TB treatment or received treatment for less than 14 consecutive days.
- \. Provide Informed Consent.
You may not qualify if:
- \. Blood handling was not completed using QFT-Plus
- \. Incubation was \<16 and \>24 hours
- \. Improperly collected and/or stored samples per Instructions For Use
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Biospecimen
Plasma, whole blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2020
First Posted
January 27, 2020
Study Start
April 1, 2020
Primary Completion
August 1, 2020
Study Completion
November 1, 2020
Last Updated
September 16, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share