Point of care immunoassay for rapid diagnosis of tinea capitis

Information

  • Research Project
  • 9232422
  • ApplicationId
    9232422
  • Core Project Number
    R43EB023408
  • Full Project Number
    1R43EB023408-01
  • Serial Number
    023408
  • FOA Number
    RFA-EB-16-001
  • Sub Project Id
  • Project Start Date
    9/1/2016 - 8 years ago
  • Project End Date
    7/31/2018 - 6 years ago
  • Program Officer Name
    LASH, TIFFANI BAILEY
  • Budget Start Date
    9/1/2016 - 8 years ago
  • Budget End Date
    7/31/2017 - 7 years ago
  • Fiscal Year
    2016
  • Support Year
    01
  • Suffix
  • Award Notice Date
    8/29/2016 - 8 years ago
Organizations

Point of care immunoassay for rapid diagnosis of tinea capitis

Tinea capitis (scalp ringworm) is a fungal dermatophyte infection of scalp hair follicles that afflicts 3-8% 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 1 will optimize procedures for sample treatment and extraction of galactomannan from dermatophytes. Aim 2 will optimize a prototype lateral flow immunoassay for detection of galactomannan in a single-step POC format. Aim 3 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.

IC Name
NATIONAL INSTITUTE OF BIOMEDICAL IMAGING AND BIOENGINEERING
  • Activity
    R43
  • Administering IC
    EB
  • Application Type
    1
  • Direct Cost Amount
  • Indirect Cost Amount
  • Total Cost
    199920
  • Sub Project Total Cost
  • ARRA Funded
    False
  • CFDA Code
    286
  • Ed Inst. Type
  • Funding ICs
    NIBIB:199920\
  • Funding Mechanism
    SBIR-STTR RPGs
  • Study Section
    ZEB1
  • Study Section Name
    Special Emphasis Panel
  • Organization Name
    DXDISCOVERY, INC.
  • Organization Department
  • Organization DUNS
    078634704
  • Organization City
    RENO
  • Organization State
    NV
  • Organization Country
    UNITED STATES
  • Organization Zip Code
    895570001
  • Organization District
    UNITED STATES