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Validation of a LAMP assay for rapid and cost-effective detection and management of CRE colonized veterinary patients

Award Number: U18FD008566
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: KDA (KNOWLEDGE/DEVELOPMENT/APPLICATION)
PERIOD OF PERFORMANCE START DATE: 09/25/2025
PERIOD OF PERFORMANCE END DATE: 07/31/2026

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Validation of a LAMP assay for rapid and cost-effective detection and management of CRE colonized veterinary patients - Abstract Carbapenems are among our most precious broad-spectrum antimicrobial drugs because they are the therapy of choice for life-threatening invasive bacterial infections. Unfortunately, the increasing frequency of use of carbapenems has led to the emergence and dissemination of carbapenem-resistant Enterobacterales (CRE) in human healthcare where heavy selection pressure and population-dense environments favor the emergence and spread of highly resistant strains. CRE are now also emerging as an important antimicrobial resistance threat in veterinary medicine. Healthy companion animals in the community can become asymptomatically colonized with CRE in their enteric microbiota through normal contact with food, other animals, humans, or the natural environment including surface waters. If these animals later require veterinary care for unrelated health conditions, there is risk that their CRE colonization will be unrecognized and that the CRE will subsequently contaminate the hospital environment where other patients and staﬀ may then be exposed. The emerging threat of CRE to hospitalized veterinary patients has been described for multiple outbreaks. Unfortunately, accurate and cost-eﬀective rapid screening tests that can provide a result in time for colonized patients to be identiﬁed and appropriately managed during hospitalization to prevent transmission are not available. These tests will be needed in order to implement eﬀective surveillance and CRE infection control programs in veterinary settings. We are proposing to validate a rapid screening test for CRE colonization, implement for surveillance in our hospital patient population, and share the results with the veterinary community regarding the identiﬁcation and management of CRE colonized veterinary patients. To accomplish this, we propose to validate a LAMP assay as a screening test for patient CRE colonization using both experimental and observational methods. Our experimental method will utilize canine feces spiked with CRE at multiple dilutions to establish the ability and sensitivity of the LAMP assay to detect CRE in fecal samples. Observational data will be generated to validate the LAMP assay by testing OSU VMC patient fecal swabs in parallel with selective culture, and by testing blinded samples of known status provided by a collaborator. Once validated, we will then implement the LAMP assay for ongoing surveillance of CRE colonization in our patient population. That data on patient CRE colonization will allow us to make patient management and intervention decisions within 24 hours of patient admission. We will then disseminate information regarding LAMP assay performance and our implementation to other Vet-LIRN laboratories and to the veterinary community through scientiﬁc meetings and continuing education.


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: 2026 ( Subtotal = $0 )
2026	2025	OHIO STATE UNIVERSITY, THE	1960 KENNY RD	COLUMBUS	OH	43210	FRANKLIN	USA	Food and Drug Administration Research	000	1	11/20/2025	NEW	$0
														Subtotal = $0

Issue Date FY: 2025 ( Subtotal = $49,968 )
2025	2025	OHIO STATE UNIVERSITY, THE	1960 KENNY RD	COLUMBUS	OH	43210	FRANKLIN	USA	Food and Drug Administration Research	000	1	9/24/2025	NEW	$49,968
														Subtotal = $49,968

Grand Total All Awards = $49,968

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Validation of a LAMP assay for rapid and cost-effective detection and management of CRE colonized veterinary patients

Award Number: U18FD008566

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: KDA (KNOWLEDGE/DEVELOPMENT/APPLICATION)

PERIOD OF PERFORMANCE START DATE: 09/25/2025

PERIOD OF PERFORMANCE END DATE: 07/31/2026

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