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.

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.

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