QuantiFERON Access Clinical Performance Study Protocol

Withdrawn

• Conditions: Tuberculosis (TB)
• Interventions: Device: QFT Access

• Registration Number: NCT04243031
• Lead Sponsor: QIAGEN Gaithersburg, Inc

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-23
• Study First Submitted QC: 2020-01-23
• Study First Posted: 2020-01-27
• Study Start: 2020-04-01
• Primary Completion: 2020-08-01
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-14
• Last Update Posted: 2020-09-16
• Study Completion: 2020-11-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• 1. Be ≥ 18 years of age,
• 2. Have received no TB treatment or received treatment for less than 14 consecutive days.
• 3. Provide Informed Consent.

Exclusion Criteria

• 1. They do not meet the inclusion criteria,
• 2. Blood handling was not completed using QFT-Plus
• 3. Incubation was <16 and >24 hours
• 4. Improperly collected and/or stored samples per Instructions For Use

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All subjects	QFT Access	Those with TB and those without TB.

Primary Outcome Measures

Name	Time	Method
TB Result	At time of enrollment	QFT Access result compared to the QFT-Plus result (positive, negative)