QuantiFERON Access Clinical Performance Study Protocol

QIAGEN Gaithersburg, Inc

Overview

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.

Study Type

OBSERVATIONAL

Conditions

Tuberculosis (TB)

Interventions

QFT AccessDEVICE

Measure of Interferon Gamma

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

TB Result

QFT Access result compared to the QFT-Plus result (positive, negative)

Time frame: At time of enrollment

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.