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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04243031
Other study ID # TMF-17-1056-1
Secondary ID
Status Withdrawn
Phase
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design


Related Conditions & MeSH terms


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
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