PreFIT aims to validate ready-to-use candidate assays for incipient TB in populations of intended use across different High burden settings in Mozambique, South Africa and Uganda

These include a GeneXpert cartridge-based 3-gene signature, C-reactive protein, hemoglobin and markers of iron homeostasis. PreFIT will establish a diagnostic trial cohort of 4040 highly exposed HIV-negative and positive TB-free contacts followed prospectively for development of culture-confirmed TB disease for 12 months with candidate testing at months 0 and 6 (Figure 1). The assays will be validated for clinical performance to predict TB disease, feasibility and cost when used at point-of-care.

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