Protocols

The Feasibility of Novel Diagnostics for TB in Endemic Countries (FEND for TB) Consortium, funded by the U.S. National Institutes of Health, is comprised of a group of international clinical and laboratory investigators with the primary purpose of supporting the evaluation of early-stage tuberculosis diagnostic assays and strategies in the context of existing clinical algorithms in tuberculosis endemic countries. FEND for TB conducts early-stage diagnostic accuracy and feasibility studies and feeds back findings to assay developers to facilitate the efficiency of the iterative assay evaluation and revision process. FEND for TB investigators and study teams enroll participants in high-burden tuberculosis settings, where across each of these settings there is a spectrum of Mycobacterium tuberculosis drug resistance, HIV prevalence, the prevalence of non-tuberculous mycobacterial infections, and adult co-morbidities (infectious and non-infectious) such that the set of study sites reasonably represents the global population of individuals undergoing

Adult Protocol

Pediatric Protocol

Drug Resistant Protocol

Adult

 

Pediatric

 

Drug Resistant

 

Overall Objectives

overall Primary

To provide clinical specimens and data to FEND for TB researchers and their collaborators in order to determine the diagnostic accuracy and operating characteristics of investigational in vitro tuberculosis diagnostic assays and strategies
For each participant, conduct a pre-specified set of standard-of-care diagnostic tests in order to classify that participant’s status with respect to tuberculosis (reference standard).

overall Secondary

To gather parameter estimates for economic analyses