Rapid Test for Recent HIV Infection

Information

  • Research Project
  • 9105314
  • ApplicationId
    9105314
  • Core Project Number
    R44AI098567
  • Full Project Number
    5R44AI098567-05
  • Serial Number
    098567
  • FOA Number
    PA-10-123
  • Sub Project Id
  • Project Start Date
    9/1/2011 - 13 years ago
  • Project End Date
    6/30/2017 - 7 years ago
  • Program Officer Name
    SHARMA, USHA K.
  • Budget Start Date
    7/1/2016 - 8 years ago
  • Budget End Date
    6/30/2017 - 7 years ago
  • Fiscal Year
    2016
  • Support Year
    05
  • Suffix
  • Award Notice Date
    6/20/2016 - 8 years ago
Organizations

Rapid Test for Recent HIV Infection

DESCRIPTION (provided by applicant): Monitoring the HIV epidemic to understand rates and patterns of growth, as well as targeting intervention efforts to populations exhibiting high rates f HIV transmission, are wholly dependent on determining the frequency of new infections using an assay that discriminates recent from long-term HIV infection. However, very few HIV assays have been developed specifically to distinguish incidence from prevalence. An added barrier has been the lack of an incidence assay for field work and resource-poor settings. Most HIV serologic assays are aimed at diagnostic use, while RNA assays have been used largely to determine viral load for clinical management purposes. Furthermore, HIV incidence testing currently requires access to well-equipped centralized laboratories capable of running the few sophisticated assays available for this purpose; these have been ELISAs requiring microplate handling and reading instrumentation, including the BED ELISA and the Vironostika detuned ELISA. Dependence on a central laboratory also implies the requirement for a system to transport serum specimens from where they have been collected to the laboratory, a separate and acute logistical challenge. In this project, we propose to transform HIV serological incidence testing from ELISA methodology based on avidity and titer and requiring a laboratory with sophisticated infrastructure, to a field procedure using a simple, stable, and reliable rapid test.In Phase I, we have developed prototypes of a new, highly sensitive rapid test based on novel colorimetric detection technology, which allows the analysis of antibody titer and avidity in less than 15 minutes within a single cassette. The rapid assay is based on synthetic peptides derived from a recently developed multisubtype gp41 HIV peptide antigen (IDR-M) which is the basis for the currently state-of- the-art limiting antigen (LAg) ELISA for incidence testing. Evaluated with a CDC incidence/prevalence panel, the prototype rapid assay yielded > 98% correlation with the LAg ELISA. In Phase II, we will evaluate the accuracy of the new rapid test for classification of recent vs. long-term HIV infections using well-characterized serum/plasma panels developed specifically for this purpose. These will include a panel representing recently HIV-infected individuals (HIV RNA positive/anti-HIV negative at recruitment) collected over a two year period as a specific aim in Phase I. Field evaluations of the rapid test will be carried ot in collaboration with public health agencies at global sites in low-resource regions to determine its performance characteristics and operability. The new rapid HIV incidence test will serve a major public health need by bringing testing to identify new HIV infections to the field, where the subject is located, enabling more efficient monitoring of the HIV epidemic at a local level and more effective intervention tactics.

IC Name
NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES
  • Activity
    R44
  • Administering IC
    AI
  • Application Type
    5
  • Direct Cost Amount
  • Indirect Cost Amount
  • Total Cost
    976061
  • Sub Project Total Cost
  • ARRA Funded
    False
  • CFDA Code
    855
  • Ed Inst. Type
  • Funding ICs
    NIAID:976061\
  • Funding Mechanism
    SBIR-STTR RPGs
  • Study Section
    ZRG1
  • Study Section Name
    Special Emphasis Panel
  • Organization Name
    IMMUNETICS, INC.
  • Organization Department
  • Organization DUNS
    174347732
  • Organization City
    BOSTON
  • Organization State
    MA
  • Organization Country
    UNITED STATES
  • Organization Zip Code
    022102377
  • Organization District
    UNITED STATES