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.
Verified date | September 2020 |
Source | QIAGEN Gaithersburg, Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Withdrawn |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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
QIAGEN Gaithersburg, Inc |
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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