Attachment 1 - Specifications.pdf

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Qualitative Lateral Flow Immunoassay (Pullman, WA)
Solicitation number
1232SA25Q0253
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This document is a Specifications file for a Qualitative Lateral Flow Immunoassay solicitation issued by the USDA Agricultural Research Service. The requirement is for 100 assay prototypes designed to identify antibodies against the tick-borne bovine parasite Babesia bovis, with specific technical requirements including a dipstick or cassette format, single packaging, lateral flow design, and a desired 12-month shelf life. The prototypes must be developed through a comprehensive R&D process involving screening government-furnished samples, developing and testing assay materials, and optimizing the immunoassay.

The solicitation (Number 1232SA25Q0253) is a Small Business Set-Aside with a NAICS code of 325413 and a small business size standard of 1,250 employees. Delivery is scheduled for 90 days after receipt of order to the USDA Animal Disease Research Unit in Pullman, WA. Quotes are due by 12:00 p.m. EST on July 2, 2025, and must be submitted to spencer.hamilton@usda.gov. Additional requirements include potential training via email communications and a mandatory USDA CVB licensure for the selected vendor.

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SPECIFICATIONS

1.0 Specifica ons Descrip on:

Qualita ve Lateral Flow Immunoassay

Quan ty: 1 Assay (100 prototypes)

Unit Type: Each

Minimum Requirements:

Item Specs: Prototypes for a qualita ve lateral Flow immunoassay that supports the iden fica on of an bodies against the ck-borne bovine parasite Babesia bovis. Immunoassay prototypes should be:

1. In the form of a dips ck or casse e

2. Single Packaging

3. Format: lateral flow

4. Qualita ve

5. Visual Label

6. Desired shelf life of at least 12 months

7. Stored and shipped at room temperature or lower temperature

Incidental Services: Includes effort to demonstrate performance of custom reagents to generate the necessary sensi vity and specificity and dynamic range for the assay. This effort includes the development and manufacturing of prototypes as follows:

1. Screening/Evalua on of government furnished (blood/plasma/serum) samples

2. Vendor to provide other reagents and standard lab chemicals/supplies as necessary

3. Development/tes ng of assay materials

4. Op miza on of assay materials to establish feasible assay

5. Recording and repor ng of all development, ac vi es, studies, and materials used

6. Shipping of assay prototypes to customer

7. No intellectual property to be associated with the development, use, or interpreta on of the device.

2.0 Place of Delivery

Delivery will be made to:

3003 ADBF

Pullman, WA 99164-6630 c/o David Herndon

*Product should not be sufficiently large that any addi onal accommoda ons are required (i.e. no loading dock requirement).

3.0 Delivery and Incidental Service Schedule

Item/Incidental Service QTY Unit Place of Delivery Delivery Date Assay Prototypes (also iden fied as 1 assay) 100 ea See Sec on 2.0 90 Days ARO Research & Development Services - billing cycle per assay

3 ea Done prior to deliverables

90 Days ARO

4.0 Delivery Point of Contact

David R. Herndon; david.herndon@usda.gov, (509) 335-6004

5.0 Addi onal Requirements

a. Are there any Security requirements -NA

b. Is Installa on required? - NA

c. Is Assembly required?- NA

d. Is a warranty required? - NA

e. Is training required for use of this item?

i. Training may be required for use of the deliverable. Training would entail informa on sharing on the types of samples (serum/plasma vs. blood) as well as any addi onal informa on related to performance of the assay. This training would be sufficiently handled via email communica ons between the vendor and the technical point of contact.

ii. USDA CVB licensure is necessary

File details come from the government source that posted it. Updated .