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QuantiFERON Access Clinical Performance Study Protocol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04243031
Recruitment Status : Withdrawn (Business Decision)
First Posted : January 27, 2020
Last Update Posted : September 16, 2020
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Tuberculosis (TB) Device: QFT Access

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
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.
Estimated Study Start Date : April 1, 2020
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : November 1, 2020

Group/Cohort Intervention/treatment
All subjects
Those with TB and those without TB.
Device: QFT Access
Measure of Interferon Gamma

Primary Outcome Measures :
  1. TB Result [ Time Frame: At time of enrollment ]
    QFT Access result compared to the QFT-Plus result (positive, negative)

Biospecimen Retention:   Samples With DNA
Plasma, whole blood

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants coming to clinic

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
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Responsible Party: QIAGEN Gaithersburg, Inc Identifier: NCT04243031    
Other Study ID Numbers: TMF-17-1056-1
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses