Point of care immunoassay for rapid diagnosis of tinea capitis

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43EB023408-01
Agency Tracking Number: R43EB023408
Amount: $420,640.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NIBIB
Solicitation Number: EB16-001
Timeline
Solicitation Year: 2016
Award Year: 2016
Award Start Date (Proposal Award Date): 2016-09-01
Award End Date (Contract End Date): 2019-07-31
Small Business Information
1664 N. Virginia st., Reno, NV, 89557-0001
DUNS: 078634704
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 AMANDA BURNHAMMARUSICH
 (775) 784-6264
 burnham.marusich@dxdiscovery.com
Business Contact
 DAVID MAINE
Phone: (775) 784-7722
Email: dmaine@dxdiscovery.com
Research Institution
N/A
Abstract
Tinea capitis scalp ringworm is a fungal dermatophyte infection of scalp hair follicles that afflicts of the U S pediatric population Tinea capitis is a major health care disparity because it occurs predominantly among individuals with a disadvantaged socioeconomic background and sub Saharan African descent Diagnosis of tinea capitis is currently dependent on culture and microscopy Both are expensive take time and require considerable expertise The goal of this project is an immunoassay that will rapidly identify the presence of dermatophyte fungi in skin scrapings and hair 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 galactomannans as biomarkers for dermatophyte fungi The product will be a rapid and inexpensive lateral flow immunoassay LFIA The LFIA platform is familiar to health care workers and patients alike because the format is identical to that of the home pregnancy test As a consequence there would be ready acceptance of the test by all stakeholders In preliminary studies a multi step research grade LFIA was produced that is reactive with galactomannans of all major dermatophytes as well as extracts of clinical samples from patients with dermatophyte infection The objective of this Phase I proposal is to move the current research grade LFIA to a format suitable for point of care POC use This objective will be completed by pursuit of three specific aims Aim will optimize procedures for sample treatment and extraction of galactomannan from dermatophytes Aim will optimize a prototype lateral flow immunoassay for detection of galactomannan in a single step POC format Aim will evaluate a prototype tinea capitis LFIA using clinical samples If successful this study will produce a diagnostic test that is efficient effective affordable culturally acceptable and deliverable to sites that serve health disparity populations The result will be rapid diagnosis and treatment of an infection that stigmatizes children keeps them from school until treatment is initiated and adds a considerable cost to the health care system Tinea capitis scalp ringworm is a fungal infection of scalp hair follicles that afflicts of the U S pediatric population predominantly children with a disadvantaged socioeconomic background and sub Saharan African descent The goal is to produce a diagnostic test for tinea capitis that is effective affordable culturally acceptable and deliverable to sites that serve health disparity populations

* Information listed above is at the time of submission. *

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