Aim: This study is aimed at collecting sufficient data that will help to provide evidence for the safety and effectiveness of the LIAISON® QuantiFERON® - TB Gold Plus assay using the LIAISON® analyzer family to support the proposed intended use statement and product labeling claims in the diagnosis of active TB in a TB-endemic setting.
Method: It is a cross-sectional study conducted among patients with active TB disease in Dar es Salaam, Tanzania. The study will involve 200 consenting adults (aged 18-80 years) presenting with signs and symptoms of TB who have been diagnosed to have active TB based on a positive GeneXpert (a nucleic acid amplification test). Patients collect sputum and whole blood samples. Sputum samples will be sent for sputum culture for confirmation of M. tuberculosis. Harvested plasma will be analyzed using the LIAISON XL Analyzer for antibodies against M. Tuberculosis