Pertussis (whooping cough) is rapidly re-emerging as a serious public health threat in the United States. Current diagnostics (PCR and culture) are slow, expensive and require a high level of user expertise. The goal of this project is to resolve a critical public health need for improved pertussis diagnostics by developing a point-of-care immunoassay that can diagnose early-stage pertussis in minutes, at very low cost, and without the need for specialized equipment or user expertise. A point-of-care immunoassay will dramatically increase early pertussis diagnosis, which will i) initiate prompt treatment, ii) reduce disease severity and duration, iii) limit outbreaks by preventing unnecessary transmission, and iv) save infant lives.
In Phase I of this project, which was funded by a small business innovation research (SBIR) grant from the National Institute of Allergy and Infectious Disease, we identified several candidate biomarkers of pertussis infection and developed prototype immunoassays to detect them (ELISA and lateral flow). A three-year long Phase II award has now been made to DxDiscovery from the National Institute of Allergy and Infectious Disease for further development of an advanced, point-of-care, monoclonal antibody-based diagnostic and for the device’s evaluation with animal model and patient samples. Dr. Amanda Burnham-Marusich and Dr. Thomas Kozel are Co-Principal Investigators on the project, which has a collaborative sub-award component to the University of Nevada, Reno School of Medicine.