In this work we will develop and field validate FeverPhone technology for point-of-care differential diagnosis of six common causes of acute febrile illness (namely: Dengue, Malaria, Chikungunya, Leptospirosis, Typhoid fever, and Chagas). The FeverPhone system builds on our team's extensive background on the development of smartphone based diagnostics, infectious disease, and global health. The technical effort of this program comprises of the development of: a specialized 6-plexed colorimetric IgM/IgG assay cartridge that exploits our previous work on color discrimination assays on mobile devices, associated iPad based hardware that allows rapid interpretation of the cartridge results on a platform already used by our field technicians, and software that will combine differential molecular diagnosis with a confirmatory symptomatic interface used by the operator. The final system will enable actionable diagnosis in around 15 minutes. In parallel with technical development, we will perform a staged field validation study at our existing infectious diseases monitoring site in Machala, Ecuador. In addition to clinical and engineering expertise, we have incorporated a translation partner into the program that will ensure that our system is fully validated and ready for FDA approval by the end of the effort.

Public Health Relevance

Acute undifferentiated febrile illnesses are responsible for substantial morbidity and mortality globally along with imposing a considerable economic cost, primarily in developing country settings. The development of a real time, rapid, and accurate diagnostic technique to identify the causative pathogen would shift current practices from syndromic-based diagnosis to more personalized diagnosis and informed treatment decisions.

Agency
National Institute of Health (NIH)
Institute
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Type
Research Project (R01)
Project #
1R01EB021331-01
Application #
9008392
Study Section
Special Emphasis Panel (ZRG1-BCHI-Z (04))
Program Officer
Lash, Tiffani Bailey
Project Start
2016-07-01
Project End
2020-03-31
Budget Start
2016-07-01
Budget End
2017-03-31
Support Year
1
Fiscal Year
2016
Total Cost
$611,617
Indirect Cost
$212,346
Name
Cornell University
Department
Engineering (All Types)
Type
Schools of Engineering
DUNS #
872612445
City
Ithaca
State
NY
Country
United States
Zip Code
14850
Lu, Zhengda; Rey, Elizabeth; Vemulapati, Sasank et al. (2018) High-yield paper-based quantitative blood separation system. Lab Chip 18:3865-3871
Lu, Zhengda; O'Dell, Dakota; Srinivasan, Balaji et al. (2017) Rapid diagnostic testing platform for iron and vitamin A deficiency. Proc Natl Acad Sci U S A 114:13513-13518
Rey, Elizabeth G; O'Dell, Dakota; Mehta, Saurabh et al. (2017) Mitigating the Hook Effect in Lateral Flow Sandwich Immunoassays Using Real-Time Reaction Kinetics. Anal Chem 89:5095-5100
Lee, Seoho; Mehta, Saurabh; Erickson, David (2016) Two-Color Lateral Flow Assay for Multiplex Detection of Causative Agents Behind Acute Febrile Illnesses. Anal Chem 88:8359-63