QuantiFERON Access Clinical Performance Study Protocol

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.

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04243031

Enrollment

Registered

2020-01-27

Start date

2020-04-01

Completion date

2020-11-01

Last updated

2020-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis (TB)

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.

Interventions

DEVICEQFT Access

Measure of Interferon Gamma

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026