URINE-BASED POINT-OF-CARE CHLAMYDIA/GONORRHOEA TEST

Information

  • Research Project
  • 6405704
  • ApplicationId
    6405704
  • Core Project Number
    R44PS000027
  • Full Project Number
    2R44PS000027-02
  • Serial Number
    27
  • FOA Number
  • Sub Project Id
  • Project Start Date
    9/30/1999 - 25 years ago
  • Project End Date
    9/29/2003 - 21 years ago
  • Program Officer Name
    SANDUL, AMY
  • Budget Start Date
    9/30/2001 - 23 years ago
  • Budget End Date
    9/29/2002 - 22 years ago
  • Fiscal Year
    2001
  • Support Year
    2
  • Suffix
  • Award Notice Date
    9/24/2001 - 23 years ago
Organizations

URINE-BASED POINT-OF-CARE CHLAMYDIA/GONORRHOEA TEST

DESCRIPTION (provided by applicant): During phase I Xtrana/BioPool (formerly Molecular Innovations, Inc.) demonstrated the feasibility of a urine-based diagnostic test that potentially could be performed in the clinic to detect both genital chlamydia and gonorrhea. The strategy involves the release of Chlamydia trachomatis (CT) and Neisseria gonorrhoea (GC) ribosomal RNA, capture onto Xtrana/Biopool's XtraBind solid phase bead matrix, followed by direct isothennal amplification using Nucleic Acid Sequence Based Amplification (NASBA). After NASBA, haptenized primers are added so that the amplified product is directly visualized as a blue line immediately following wicking through a lateral flow membrane. The integration of solid phase capture, direct isothermal amplification, and visual lateral flow detection enables device platforms with simple protocols compatible with nucleic acid testing at the point-of-care at reduced cost using only a heat block for instrumentation. Finalized chemistry, device design, prototyping, and manufacturing, followed by clinical validation studies will be performed in phase II. At the conclusion of phase 11, extraction, amplification, and detection chemistry run within the prototype will be completed and its performance characterized utilizing urine specimens. PROPOSED COMMERCIAL APPLICATION: Not Available

IC Name
NATIONAL CENTER FOR HIV, VIRAL HEPATITIS, STDS AND TB PREVENTION
  • Activity
    R44
  • Administering IC
    PS
  • Application Type
    2
  • Direct Cost Amount
  • Indirect Cost Amount
  • Total Cost
  • Sub Project Total Cost
  • ARRA Funded
  • CFDA Code
  • Ed Inst. Type
  • Funding ICs
  • Funding Mechanism
  • Study Section
    ZRG1
  • Study Section Name
    Special Emphasis Panel
  • Organization Name
    XTRANA, INC.
  • Organization Department
  • Organization DUNS
  • Organization City
    DENVER
  • Organization State
    CO
  • Organization Country
    UNITED STATES
  • Organization Zip Code
    80220
  • Organization District
    UNITED STATES