Qualitative Lateral Flow Immunoassay Manufacturing

Form / Attachment / Pricing Sheet

This document is the "Buy American Certificate" (FAR 52.225-2, OCT 2022). It requires offerors to certify the domestic content of end products proposed for this solicitation.

• Domestic End Product Certification: Offerors must certify that each end product, unless listed as a foreign end product, is domestic and contains a critical component.
• Foreign End Product Listing: Offerors must list foreign end products, their country of origin, and indicate if they exceed 55% domestic content (unless they are COTS items).
• Critical Component Identification: Offerors must list domestic end products that contain a critical component.
• Definitions: Key terms such as "COTS item," "critical component," "domestic end product," "end product," and "foreign end product" are defined within the solicitation.

Bidders must complete and submit this certificate as part of their proposal. Failure to provide accurate information may impact the evaluation of their offer, as the government will evaluate offers in accordance with FAR Part 25. This form directly addresses the Buy American Act requirements for the solicitation.

Solicitation / RFP / RFQ

This is a combined synopsis/solicitation for commercial items, serving as the sole solicitation for Qualitative Lateral Flow Immunoassay Manufacturing. The acquisition is set-aside for small business concerns, with NAICS code 325413 and a size standard of 1,250 employees.

• The core requirement is for Qualitative Lateral Flow Immunoassay Manufacturing, as detailed in the attached Statement of Work (Attachment 2).

• Responses must include a detailed description of the capability to perform the manufacturing and relevant experience.

• Offerors must provide documentation of their USDA CVB licensure.

• Anticipated contract type: Firm-fixed price.

• Period of Performance: 12 weeks After Receipt of Order (ARO).

• The government intends to make one award.

• Quotes are due no later than 10:00 am Mountain Time on Monday, April 13, 2026.

• Submission is electronic via email to frank.palmer@usda.gov. Faxed or hard copy quotes are not allowed.

• The final day for question submission is 10:00 am Mountain Time on Wednesday, April 8, 2026.

• Award will be made on a Best Value basis, considering price and other factors. The evaluation will involve a comparative assessment of quotes based on Technical Capabilities, Relevant Experience, Past Performance, and Price.

• Total Small Business Set-Aside.

• All responsible sources may submit a quotation.

• Vendors must be active and registered in the System for Award Management (SAM.gov) at the time of quote submission and award.

• Applicable clauses and provisions are incorporated by reference (full text available at www.acquisition.gov).

• Payment will be made via the Department of the Treasury Invoice Processing Platform (IPP).

• Quotes that merely offer to provide the immunoassay as described in the SOW will not receive further consideration.

Statement of Work (SOW)

Development and manufacturing of a qualitative lateral flow immunoassay to detect antibodies against tick-borne bovine blood parasites, including Babesia bovis, Anaplasma marginale, and/or Theileria equi/haneyi.

• Optimization of all components for a lateral flow device (membranes, supports, conjugate delivery pads, wicking pads, sample pads, detection markers, buffers, and reagents).

• Development and manufacturing of 100 prototype assays (dipstick or cassette format) with single packaging and a visual label.

• Assay prototypes must demonstrate successful lateral flow development for detecting blood/plasma antibodies in response to pathogen infection.

• Prototypes must have a desired shelf life of at least 12 months and be stored/shipped at room temperature or lower.

• Demonstrate performance of custom reagents for sensitivity, specificity, and dynamic range.

• Screening/evaluation of government-furnished samples (blood/plasma/serum).

• Vendor to provide necessary reagents and lab chemicals/supplies.

• Development and testing of assay materials.

• Optimization of assay materials.

• Recording and reporting of all development activities, studies, and materials used.

• Shipping of assay prototypes to the customer.

• No intellectual property associated with the development, use, or interpretation of the device.

• Place of Delivery: USDA Animal Disease Research Unit, Pullman, WA.

• Delivery Date for Assay Prototypes: 12 weeks after award.

• Research & Development Services: Done prior to deliverables, within 12 weeks of award.

• USDA CVB licensure is required.

• Training may be required for assay use, to be handled via email communications.