Tinea capitis (scalp ringworm) is a fungal dermatophyte infection of scalp hair follicles and surrounding skin that afflicts 3-8% of the U.S. pediatric population. The clinical presentation is that of hair loss accompanied by inflammation, scaling, pustules, and itching. Tinea capitis is also a major health care disparity because it occurs predominantly among individuals from disadvantaged socioeconomic backgrounds and sub-Saharan African descent. In addition to the medical impact on the patient, tinea capitis also stigmatizes disadvantaged children (e.g. increased bullying, social ostracism), keeps them from school until treated, and adds health care cost in a population least able to pay.
Treatment for tinea capitis requires a prolonged (weeks) treatment with oral antifungal agents, which raises issues of patient compliance, side effects of systemic antifungals, and active antifungal stewardship. Consequently, treatment should not be initiated unless a clear diagnosis is made. Unfortunately, the diagnosis of tinea capitis is currently dependent on culture and microscopy. Both methods are slow (days to weeks for results), expensive, and require considerable expertise.
Our goal is to produce a point-of-care diagnostic test for tinea capitis that is rapid, accurate, affordable, and deliverable to sites that serve health disparity populations. The target population will be individuals, primarily disadvantaged children, with a clinical presentation of tinea capitis. The approach will be an immunoassay for cell wall polysaccharides as biomarkers for dermatophyte fungi. The product will be a rapid (<10 minutes) and inexpensive lateral flow immunoassay (LFIA) that will directly identify the presence of dermatophyte fungi in skin scrapings and hair. A positive result would trigger immediate treatment.
We have already developed a multi-step, research-grade LFIA that is reactive with galactomannans of all major dermatophytes as well as with extracts of clinical samples from several patients with dermatophyte infection. The objective of this study is to move the current research-grade LFIA to a format suitable for point-of-care (POC) use, which will involve i) developing sample treatment and biomarker extraction procedures that can be performed in less than 10min in a primary care physician office, ii) optimizing a one-step LFI for easy use at the POC, and iii) evaluating the LFI with clinical samples.
Project Investigators: Thomas Kozel, Ph.D. (Principal Investigator for Diagnostics Discovery Laboratory subcontract) and Amanda Burnham-Marusich, Ph.D. (Principal Scientist, DxDiscovery, Inc.).
Grant support: Studies at UNR are supported by a subcontract from DxDiscovery, Inc., a UNR startup company that has received a Phase I Small Business Innovation Research (SBIR) NIH grant (1R43EB023408), Point-of-care immunoassay for rapid diagnosis of tinea capitis, 2016-2018.