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Increasing the diagnostic PCR and next-generation sequencing capacity for the diagnosis and variant detection of COVID-19 in animals at the North Dakota State University Veterinary Diagnostic Lab

Award Number: U18FD007519
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: KDA (KNOWLEDGE/DEVELOPMENT/APPLICATION)
PERIOD OF PERFORMANCE START DATE: 09/15/2021
PERIOD OF PERFORMANCE END DATE: 09/30/2022

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Increasing the diagnostic PCR and next-generation sequencing capacity for the diagnosis and variant detection of COVID-19 in animals at the North Dakota State University Veterinary Diagnostic Lab - Summary The primary goal of this project is to increase the capacity for next-generation sequencing (NGS) and SARS-CoV-2 variant detection for the diagnosis of COVID-19 in animals by validating commercially available reagent kits for extraction, PCR, and NGS using a dedicated one-way NGS workflow. This will add the NDSU-VDL to the network of veterinary diagnostic laboratories capable and proficient at testing and sequencing SARS-CoV- 2 in samples from animals. To build this capacity, reagents and dedicated equipment for a one- way workflow are needed. There are three specific aims. 1) Validate the Applied Biosystems™ COVID-19 TaqPath™ Combo Kit for the detection of SARS-CoV-2 and diagnosis of COVID-19 in animal samples. Targeted samples include tissue homogenates and swabs (nasal, oral, fecal) from animals. Extracted product can be used for downstream next generation sequencing on long or short read platforms, such as the MinION or iSeq, respectively. 2) Create a safe, one- way workflow for next generation sequencing that will minimize contamination and increase sequencing capacity by allowing multiple technicians to work on different steps in the process at the same time. 3) Diagnose SARS-CoV-2 variants through next generation sequencing on the MinION platform. This will be accomplished using the NEBNext® ARTIC SARS-CoV-2 Companion Kit and protocol for the MinION for NGS and following the EPI2ME analysis pipeline. The use of the flongle flow cells will be evaluated to reduce sequencing costs. In addition, the amount of time, cost, and ease of use of this NGS library prep kit and analysis pipline will the compared with other laboratories evaluating different kits.


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: 2023 ( Subtotal = $0 )
2023	2021	NORTH DAKOTA STATE UNIVERSITY	1310 BOLLEY DR	FARGO	ND	58105	CASS	USA	Food and Drug Administration Research	000	1	12/30/2022	NEW	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $59,941 )
2021	2021	NORTH DAKOTA STATE UNIVERSITY	1919 UNIVERSITY DR N, STE 102	FARGO	ND	58102	CASS	USA	Food and Drug Administration Research	000	1	9/20/2021	NEW	$59,941
														Subtotal = $59,941

Grand Total All Awards = $59,941

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Increasing the diagnostic PCR and next-generation sequencing capacity for the diagnosis and variant detection of COVID-19 in animals at the North Dakota State University Veterinary Diagnostic Lab

Award Number: U18FD007519

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 09/15/2021

PERIOD OF PERFORMANCE END DATE: 09/30/2022

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