In response to RFA-AI-19-030, Feasibility of Novel Diagnostics for TB in Endemic Countries (FEND-TB) the leadership team has brought together a consortium of experienced investigators and clinical sites and developed a research plan to address critical unmet TB diagnostic needs. This program benefits from experience gained during the successful 7-year tenure of the NIH DMID-funded TB-Clinical Diagnostics Research Consortium (TB-CDRC), with overlap in leadership, investigators and sites. This program has been adapted in several ways to further enhance capacity to meet the current challenges in the field -- the successful collaboration with the Foundation for Innovative New Diagnostics (FIND) has been strengthened to now a full partnership that will facilitate access to cutting edge technologies and alignment of FEND-TB work with global stakeholder priorities; clinical study sites in India and Peru have been added to accelerate recruitment and augment capacity to enroll patients with co-morbidities and drug- resistance; inclusion of a mature analytic laboratory and revised technology evaluation strategy that together allow for rational, nimble, step-wise evaluation of early-stage diagnostics; and inclusion of mathematical modeling capacity to inform optimal diagnostic strategies in TB endemic settings. This proposal will test two main hypotheses: A. Novel early stage TB diagnostics, that target bacterial and/or host targets and will be ready for evaluation in the next five years, will have performance characteristics suitable for point of care (POC)/near-care use for TB detection, triage, or drug susceptibility testing. B. Rapid non-sputum diagnostics will provide ancillary support as components of algorithms for the diagnosis of childhood TB as well as paucibacillary pulmonary TB and extrapulmonary TB in adults.
Specific Aims are: 1. To evaluate the diagnostic accuracy of early stage diagnostic tests for tuberculosis. 2. To identify new early stage diagnostics for evaluation, and to develop and implement for each a stepwise evaluation plan. 3. To use economic analysis and transmission modelling to design optimal diagnostic algorithms.

Public Health Relevance

Tuberculosis is a leading cause of death due to an infectious disease. Most cases occur in low and middle income countries where access to diagnostics such as culture may be limited to a few reference centers. FEND for TB will identify and assess inexpensive tests that are available at the point of care where the patients first are evaluated; once validated, these tests will enable more rapid identification and treatment of TB.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project--Cooperative Agreements (U01)
Project #
1U01AI152084-01
Application #
9981978
Study Section
Special Emphasis Panel (ZAI1)
Program Officer
Lacourciere, Karen A
Project Start
2020-06-04
Project End
2025-05-31
Budget Start
2020-06-04
Budget End
2021-05-31
Support Year
1
Fiscal Year
2020
Total Cost
Indirect Cost
Name
Rutgers University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
078795851
City
Newark
State
NJ
Country
United States
Zip Code
07103