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An antigen-capture assay to screen donated blood for Babesia microti

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43AI142877-01
Agency Tracking Number: R43AI142877
Amount: $599,624.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NIAID
Solicitation Number: PA18-574
Timeline
Solicitation Year: 2018
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-03-14
Award End Date (Contract End Date): 2021-02-28
Small Business Information
18 WOODHULL RD
East Setauket, NY 11733-3728
United States
DUNS: 140704532
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 PAUL ARNABOLDI
 (914) 594-4184
 paul_arnaboldi@nymc.edu
Business Contact
 RAYMOND DATTWYLER
Phone: (516) 662-3287
Email: rdattwyler@mac.com
Research Institution
N/A
Abstract

PROJECT SUMMARY
In the U.S. ~5 million individuals receive blood transfusions annually. Increasingly, these recipients are being
put at risk of infection with Babesia microti, a tick-transmitted blood-borne parasite that resides in red blood
cells (RBCs) and causes the disease babesiosis. B. microti represents a significant threat to the US blood
supply as it survives blood banking procedures and storage conditions, and can be transmitted via transfusion.
Transfusion transmitted babesiosis (TTB) is responsible for the highest percentage of transfusion-related
infectious fatalities reported to the FDA. There is a critical unmet need for a method that is sensitive and
specific, cost-effective, and high-throughput to screen donated blood for this pathogen. We propose the
development of an EIA-based antigen-capture assay capable of detecting low levels of parasites in blood
donors who are likely unaware that they are infected (e.g., asymptomatic, chronic carriers). We generated a
library of antibodies using B. microti infected mice, and then screened this library to identify antibodies specific
to parasite surface-expressed/secreted proteins. Using these methods, we have identified antibodies to
seven B. microti proteins expressed during mammalian infection. In this study, we will generate an optimized
antigen-capture assay using antibody pairs to one or more parasite secreted/surface target antigens that we
have identified in preliminary studies. In Specific Aim 1, we will optimize capture and reporter antibody pairs
for use in an antigen capture assay for the detection of B. microti, and confirm the specificity and sensitivity
of these capture-reporter antibody pairs. In Specific Aim 2, we will performance our assay using blood
obtained from patients with babesiosis, and identify a finalized antigen-capture assay to proceed to clinical
assay screening with our commercialization partner in a phase II application.PROJECT NARRATIVE
B. microti has emerged as the highest-ranking pathogen transmitted by blood transfusion in the US for which
widespread donor screening is not performed. The goal of this proposal is to meet that need through the
creation of a high-throughput, cost effective parasite detection assay with high sensitivity and specificity that
can be implemented by blood banks to prevent transfusion-transmitted babesiosis in the US.

* Information listed above is at the time of submission. *

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