Pertussis is a serious and potentially life-threatening respiratory disease caused by the bacterium Bordetella pertussis. Worldwide, 18 million people become ill with pertussis each year, and 250,000 of these patients die. Despite high vaccine coverage in the United States, there were still 33,000 pertussis cases reported in the U.S. in 2014, with a recent peak of 48,000 reported U.S. pertussis cases in 2012. Rapid diagnosis of pertussis is critical because treatment and outbreak containment are only effective if initiated early in the disease. Currently, there are no assays that can rapidly and accurately detect early-stage pertussis.

The goal is to develop a rapid, point-of-care immunoassay to detect B. pertussis during early disease. The target population will be infants who present with the non-specific, respiratory tract infection symptoms of early pertussis (prior to onset of paroxysmal cough). The approach will be detection of B. pertussis antigens from nasopharyngeal swabs by lateral flow immunoassay (LFI). The product will be an assay relevant to i) U.S. pediatrician offices, urgent care centers, and small-hospital emergency rooms, and ii) international clinics in low-resource settings: a sensitive and specific test that delivers results in ~10min at very low cost without specialized equipment or user expertise.

In Phase I of this project, we developed antibodies to several high-priority B. pertussis protein antigens and constructed LFI proof-of-concept prototypes with the requisite sensitivity and specificity. Now in Phase II, we are developing optimized monoclonal antibody-based LFIs, and we will be evaluating them with animal model and patient samples.

Project Investigators: Thomas Kozel, Ph.D. (Principal Investigator for AuCoin & Kozel Laboratories subcontract) and Amanda Burnham-Marusich, Ph.D. (Principal Scientist, DxDiscovery, Inc.).

Grant support: This study is supported by a subcontract from DxDiscovery, Inc., a UNR startup company that has received a Phase II Small Business Innovation Research (SBIR) NIH grant (2R44AI109891), Point-of-care immunoassay for early diagnosis of pertussis, 2016-2019.