You are here

An antigen-detection assay to diagnose Babesia microti infection

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44AI136118-02
Agency Tracking Number: R44AI136118
Amount: $2,076,246.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NIAID
Solicitation Number: PA19-272
Solicitation Year: 2019
Award Year: 2020
Award Start Date (Proposal Award Date): 2020-06-22
Award End Date (Contract End Date): 2023-05-31
Small Business Information
New Haven, CT 06511-6662
United States
DUNS: 142406110
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (203) 503-0383
Business Contact
Phone: (203) 393-9439
Research Institution

Human babesiosis is a malaria-like multisystem disease caused primarily by Babesia microti, an emerging
apicomplexan parasite that infects and develops within human erythrocytes. The parasite is transmitted to
humans by the tick vector Ixodes scapularis and can also be introduced through blood transfusion. Infection
can cause flu-like symptoms, and severe infection can be fatal, in particular in the immunosuppressed and the
elderly. Current methods for babesiosis diagnosis include microscopy, PCR, IFA and ELISA-based methods
that detect antibodies in serum from patients or donors. Each of these methods has major limitations, such as
insufficient sensitivity, high complexity, and low throughput. In addition, results from many of these assays
remain positive for months or years after resolution of active infection.
In Phase I of this project, we have developed a capture ELISA assay that can detect a protein of the parasite,
BmGPI12/BmSAI. We have identified pairs of monoclonal antibodies that can be used to capture BmGPI12 in
mouse and human samples. Our preliminary results demonstrate that this assay has an excellent sensitivity.
Using samples collected from infected mice, a well-established model of human disease, we demonstrated that
following successful treatment, our assay gives negative results while PCR and serology remain positive.
Thus, our assay may be useful in distinguishing active infection from past exposure.
In Phase II of this project, we will further develop this assay with the goal of applying for FDA clearance. We
will analyze several hundred animal and human samples to establish important characteristics of the assay
including sensitivity and specificity. These Phase II experiments are designed to give us a full understanding
of the potential biological indications and commercial usefulness of the assay.

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

US Flag An Official Website of the United States Government