QuantiFERON Access Clinical Performance Study Protocol

Tuberculosis (TB) Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04243031
• Other study ID #: TMF-17-1056-1
• Status: Withdrawn
• Start date: April 1, 2020
• Est. completion date: November 1, 2020

Study information

• Verified date: September 2020
• Source: QIAGEN Gaithersburg, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 1, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tuberculosis
• Tuberculosis (TB)

Intervention

Device:
• QFT Access
Measure of Interferon Gamma

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
QIAGEN Gaithersburg, Inc

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TB Result	QFT Access result compared to the QFT-Plus result (positive, negative)	At time of enrollment