Immunoassay for diagnosis of Babesia infection


Principal Investigator: ANDREW E LEVIN
Abstract: DESCRIPTION (provided by applicant): This project is aimed at development of an enzyme immunoassay (EIA) for antibodies to Babesia for use as a clinical diagnostic test. Babesiosis is an emerging tick-borne parasitic disease which may cause severe to fatal illness in immunocompromised or otherwise weakened patients, and may be carried in the blood subclinically in up to 1% of the population in endemic areas. Recent cases of fatal transfusion-transmitted babesiosis have also led to the identification of this pathogen as a significant threat to the blood supply. However, currently no commercial, validated and FDA approved tests are available for B. microti. Babesiosis is currently diagnosed by immunofluorescence staining, microscopy of blood smears, and/or PCR. None of these procedures are easily adaptable to routine clinical laboratory use. We propose to develop a microplate-based ELISA using novel synthetic B. microti antigens licensed to Immunetics that have previously been shown to be diagnostically significant markers. Specificity of the antigens will be assessed in blood donor sera from nonendemic areas and other controls. Assay performance will be evaluated on well-characterized sera from babesiosis patients from both U.S. Northeast and Midwest endemic regions. To identify immunodominant epitopes that may further improve assay sensitivity, we have identified a series of putative Babesia antigenic sequences that will be screened with babesiosis patient serum in an overlapping peptide library format, a strategy that has led to discovery of a number of antigens of diagnostic value. We also propose strategies to identify immunodominant epitopes of other pathogenic Babesia species, B. divergens/MO-1 and B. duncani/WA1. Novel immunodominant epitopes discovered through these strategies will be synthesized as peptide antigens with an appropriate structure for incorporation into current assay formats, which enable combination of multiple distinct peptides in a single-well assay. Once a single-well assay format is developed with sensitivity and specificity characteristics consistent with clinical diagnostic requirements, we will prepare for clinical trials and FDA submission in Phase II.
Funding Period: 2012-12-15 - 2014-11-30
more information: NIH RePORT

Research Grants

Detail Information

Research Grants30

  1. Southeast Regional Centers of Excellence for Biodefense &Emerging Infectious Di
    Philip Frederick Sparling; Fiscal Year: 2013
    ..SERCEB brings new investigators to the biodefense effort through a combination of educational programs, support of innovative new projects, and the synergistic interactions among its world-class investigators. ..
  2. Pacific NorthWest Regional Center of Excellence (PNWRCE)
    Jay A Nelson; Fiscal Year: 2013
    ..pseudomallei host pathogen response during both the septicemic as well as the intracellular phases of the disease. ..
  3. Confirmatory Immunoblot Test for Chagas'Disease
    ANDREW E LEVIN; Fiscal Year: 2013
    ..In this project we propose to complete development, validate and submit for regulatory approval a confirmatory immunoblot test for Chagas'disease, for use in patient diagnosis and blood donor screening. ..
  4. A prospective evaluation of chronic B.microti infection in seroreactive blood don
    EVAN MARTIN BLOCH; Fiscal Year: 2013
    ..PCR) and policy of deferral and reinstatement. We intend to use the sample repository for a future submission to determine the genetic and immunologic determinants of chronic vs. transient infection. ..
  5. Babesiosis: An Emerging Infectious Threat to Transfusion Medicine
    Cheryl Ann Lobo; Fiscal Year: 2013
    ..Recognizing that Babesia is an expanding blood safety threat we are interested in the development of viable interventions to detect and halt transmission of these pathogens via blood transfusions. ..
    Richard B Lipton; Fiscal Year: 2013
    ..Together, these Projects will help disentangle the multifactorial processes that lead to cognitive and locomotor decline and dementia. ..
  7. IPF Fibroblast Phenotype
    Craig A Henke; Fiscal Year: 2013
    ..A major objective of this Program Project is to inform decisions of the IPF Clinical Network by providing information that can be translated into novel therapeutic strategies for IPF. ..