QuantiFERON Access Clinical Performance Study Protocol

Qiagen

Status: Withdrawn

Conditions: Tuberculosis (TB)

Treatments: Device: QFT Access

Study type: Observational

Funder types: Industry

Identifiers

NCT04243031

TMF-17-1056-1

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

0 participants in 1 patient group

All subjects

Description:

Those with TB and those without TB.

Treatment:

Device: QFT Access