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

Award Number: R43AI142877
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 03/14/2019
PERIOD OF PERFORMANCE END DATE: 11/30/2021

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


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2020	BIOPEPTIDES CORP	18 WOODHULL RD	EAST SETAUKET	NY	11733	SUFFOLK	USA	Allergy and Infectious Diseases Research	000	2	4/6/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $299,812 )
2020	2020	BIOPEPTIDES CORP	18 WOODHULL RD	EAST SETAUKET	NY	11733	SUFFOLK	USA	Allergy and Infectious Diseases Research	000	2	2/4/2020	NON-COMPETING CONTINUATION	$299,812
														Subtotal = $299,812

Issue Date FY: 2019 ( Subtotal = $299,812 )
2019	2019	BIOPEPTIDES CORP	18 WOODHULL RD	EAST SETAUKET	NY	11733	SUFFOLK	USA	Allergy and Infectious Diseases Research	000	1	3/14/2019	NEW	$299,812
														Subtotal = $299,812

Grand Total All Awards = $599,624

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

Award Number: R43AI142877

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 03/14/2019

PERIOD OF PERFORMANCE END DATE: 11/30/2021

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