Respiratory Panel Flow-Strip: a Point-of-Care Molecular Diagnostic Test

Information

  • Research Project
  • 8314204
  • ApplicationId
    8314204
  • Core Project Number
    R43AI096592
  • Full Project Number
    1R43AI096592-01A1
  • Serial Number
    096592
  • FOA Number
    PA-11-096
  • Sub Project Id
  • Project Start Date
    3/1/2012 - 12 years ago
  • Project End Date
    2/28/2013 - 11 years ago
  • Program Officer Name
    KRAFFT, AMY
  • Budget Start Date
    3/1/2012 - 12 years ago
  • Budget End Date
    2/28/2013 - 11 years ago
  • Fiscal Year
    2012
  • Support Year
    01
  • Suffix
    A1
  • Award Notice Date
    2/16/2012 - 12 years ago
Organizations

Respiratory Panel Flow-Strip: a Point-of-Care Molecular Diagnostic Test

DESCRIPTION (provided by applicant): Acute respiratory infections are the third leading cause of death worldwide, and account for 4.2 million deaths annually; more than 40% are children under five. Conventional techniques are often either too slow (e.g., conventional cultures require 5 to 10 days) or too insensitive (e.g., one study found the sensitivity of a laterl flow immunoassay test for flu to be as low as 10.4%). Despite their insensitivity, the lateral flow test market for infectious disease grew over 40% in 2009. Because of its sensitivity and specificity, molecular testing are beginning to supplant conventional culture as the gold standard. However, limitations with current molecular tests for identifying multiple respiratory pathogens from a single sample include: high complexity operation, lack of sensitivity, lack of respiratory pathogen coverage, and/or lack of sequence coverage for a given pathogen. Thus, we propose to address these limitations with an automated sample-to-answer point-of- care molecular device that identifies hypervariable genomes across the following panel of respiratory pathogens: influenza A virus, influenza B virus, human respiratory syncytial virus A/B, human adenovirus A/B/C/D/E/F, human coronavirus 229E/NL63/OC43, metapneumovirus, human rhinovirus A/B/C, human bocavirus 1/2/3/4, human parainfluenza virus 1/2/3/4, Haemophilus influenzae, Streptococcus pneumoniae, Mycoplasma pneumoniae, Chlamydophila pneumoniae, Legionella pneumophila, and Bordetella pertussis. PUBLIC HEALTH RELEVANCE: Acute respiratory infections are the third leading cause of death worldwide, and account for 4.2 million deaths annually; more than 40% are children under five. The pathogens that cause these infections often are highly contagious, and infect susceptible individuals before tests can be commercialized. This project seeks to develop a point-of-care test that identifies a panel of bacteria and viruses, including drug-resistant strain of flu, from a single patient sample. This test could assist in the preparedness for global pandemics because of the ongoing availability of a test that can identify a broad panel of contagious respiratory pathogens. This strategy has the potential to eliminate the burden of having to quickly develop and commercialize single-organism tests in response to an emerging pandemic.

IC Name
NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES
  • Activity
    R43
  • Administering IC
    AI
  • Application Type
    1
  • Direct Cost Amount
  • Indirect Cost Amount
  • Total Cost
    300000
  • Sub Project Total Cost
  • ARRA Funded
    False
  • CFDA Code
    999
  • Ed Inst. Type
  • Funding ICs
    NIAID:300000\
  • Funding Mechanism
    SBIR-STTR RPGs
  • Study Section
    ZRG1
  • Study Section Name
    Special Emphasis Panel
  • Organization Name
    AKONNI BIOSYSTEMS, INC.
  • Organization Department
  • Organization DUNS
    154704444
  • Organization City
    FREDERICK
  • Organization State
    MD
  • Organization Country
    UNITED STATES
  • Organization Zip Code
    217016052
  • Organization District
    UNITED STATES