Attachment 2_SOW_Qualitative Lateral Flow Immunoassay Manufacturing.pdf
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- Attached to
- Qualitative Lateral Flow Immunoassay Manufacturing Federal contract opportunity
- Solicitation number
- 1232SA26Q0384
About this file
This is a Statement of Work for the development and manufacturing of qualitative lateral flow immunoassay prototypes. The USDA Animal Disease Research Unit requires the development of 100 prototype dipstick or cassette-format immunoassays capable of detecting antibodies against tick-borne bovine blood parasites, specifically Babesia bovis, Anaplasma marginale, and Theileria equi/haneyi. The contractor must demonstrate prior successful experience developing lateral flow devices for detecting blood or plasma antibodies in response to pathogen infection.
The assay prototypes must meet specific requirements including qualitative results with visual labels, a desired shelf life of at least 12 months, and storage/shipment capability at room temperature or lower. Incidental services include screening and evaluation of government-furnished blood, plasma, and serum samples; development and optimization of custom reagents and assay materials; and comprehensive documentation of all development activities and materials used. The contractor must provide all necessary reagents and standard laboratory chemicals beyond government-furnished samples. Delivery of 100 assay prototypes is due 12 weeks after award to the USDA Animal Disease Research Unit at Washington State University in Pullman, WA, with three billing cycles for Research & Development Services due within 12 weeks of award. Training on assay performance and sample types will be conducted via email communications. USDA CVB licensure is required, and all intellectual property associated with device development, use, or interpretation belongs to the government.
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| File | Type | Posted |
|---|---|---|
| Attachment 3_52.225-2 Buy American Certificate.pdf | ||
| Attachment 1 - Solicitation Terms and Conditions_Qualitative Lateral Flow Immunoassay Manufacturing.pdf |
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Statement of Work
Qualitative Lateral Flow Immunoassay Manufacturing
1.0 Description:
This requirement is for the development and manufacturing of a qualitative lateral flow immunoassay to detect antibodies against tick-born bovine blood parasites, including Babesia bovis, Anaplasma marginale, and/or Theileria equi/haneyi which are subjects of intense study by the USDA’s Animal
Disease Research Unit. This entails the optimization of all components necessary to build a lateral flow device, including membranes, supports, conjugate delivery pads, wicking pads, sample pads, detection markers, and all associated buffers and reagents.
Qualitative Lateral Flow Immunoassay
Quantity: 1 Assay (100 prototypes)
Unit Type: Each
Minimum Requirements:
Item Specs: Prototypes for a qualitative lateral Flow immunoassay that supports the identification of antibodies against tick-borne bovine parasites, including Babesia bovis, Anaplasma marginale, and/or Theileria equi/haneyi. Immunoassay prototypes must include the following:
1. Ability to provide examples of successful lateral flow development for the detection of blood/plasma antibodies in response to infection with a pathogen.
2. In the form of a dipstick or cassette
3. Single Packaging
4. Format: lateral flow
5. Qualitative
6. Visual Label
7. Desired shelf life of at least 12 months
8. Stored and shipped at room temperature or lower temperature
Incidental Services: Includes effort to demonstrate performance of custom reagents to generate the necessary sensitivity and specificity and dynamic range for the assay. This effort includes the development and manufacturing of prototypes as follows:
1. Screening/Evaluation of government furnished (blood/plasma/serum) samples
2. Vendor must provide other reagents and standard lab chemicals/supplies as necessary
3. Development/testing of assay materials
4. Optimization of assay materials to establish feasible assay
5. Recording and reporting of all development, activities, studies, and materials used
6. Shipping of assay prototypes to customer
7. No intellectual property to be associated with the development, use, or interpretation of the device.
2.0 Place of Delivery
Delivery will be made to:
USDA Animal Disease Research Unit
3003 ADBF, Washington State University
Pullman, WA 99164-6630 c/o David Herndon
*Product should not be sufficiently large that any additional accommodations 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 identified as 1 assay) 100 ea See Section 2.0 12 weeks after award
Research & Development Services - billing cycle per assay
3 ea Done prior to deliverables
Within 12 weeks of award
4.0 Delivery Point of Contact
David R. Herndon; david.herndon@usda.gov, (509) 335-6004
5.0 Additional Requirements
Training may be required for use of the deliverable. Training would entail information sharing on the types of samples (serum/plasma vs. blood) as well as any additional information related to performance of the assay. This training would be sufficiently handled via email communications between the vendor and the technical point of contact.
USDA CVB licensure is required mailto:david.herndon@usda.gov
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