Loading clinical trials...

QuantiFERON Access Clinical Performance Study Protocol | Clinical Trials | Clareo Health

WITHDRAWN

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.

NCT04243031•QIAGEN Gaithersburg, Inc

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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.
•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

Key Dates

Start Date

April 1, 2020

Primary Completion Date

August 1, 2020

Completion Date

November 1, 2020

Last Updated

September 16, 2020

Conditions

Tuberculosis (TB)

Interventions

QFT Access

DEVICE

A Study to Evaluate the Efficacy, Safety and Immunogenicity of MTBVAC in Adolescents and Adults Living in a TB Endemic Region.

NCT06272812

Tuberculosis (TB)

View study

RECRUITING

ESAT6/CFP10 Skin Testing for TB Infection in Rheumatologic Patients

NCT06796647

Tuberculosis (TB)

View study

RECRUITINGNA

Pharmacist-led Digital Interventions to Improve Tuberculosis Treatment Adherence

NCT07069387

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 16, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

QuantiFERON Access Clinical Performance Study Protocol

Inclusion Criteria

A Study to Evaluate the Efficacy, Safety and Immunogenicity of MTBVAC in Adolescents and Adults Living in a TB Endemic Region.

ESAT6/CFP10 Skin Testing for TB Infection in Rheumatologic Patients

Pharmacist-led Digital Interventions to Improve Tuberculosis Treatment Adherence

PRecision biomArker-Guided MAnagement of TuberculosIs Contacts: a Discrete Choice Experiment

Examining Psycho-Socioeconomic Linkages in TB Care: The UPLIFT Trial

Optimal Treatment Duration for Radiographically Apparent, Bacteriologically Unconfirmed TB, Identified Through Active Case Finding (RADIO-TB Trial)