SOLICITATION NOTICE
B -- Production and Delivery of a Portable Waveguide Immunoassay System & Development of Assays for the Portable Waveguide Immunoassay System
- Notice Date
- 7/25/2007
- Notice Type
- Solicitation Notice
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, MD, 20857-0001, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- FDA-SOL-07-00327
- Response Due
- 8/9/2007
- Description
- Production and Delivery of a Portable Waveguide Immunoassay System & Development of Assays for the Portable Waveguide Immunoassay System The Food and Drug Administration (FDA), Center for Food Safety and Applied Nutrition (CFSAN) intends to award a purchase order on a sole-source basis pursuant to FAR 6.302-1 and 41 U.S.C. 253(c)(1) to the Georgia Tech Applied Research Corporation/Georgia Tech for the Production and Delivery of a Portable Waveguide Immunoassay System & Development of Assays for the Portable Waveguide Immunoassay System. A prior CFSAN extramural cooperative research grant (#FD-U-002492-01) was awarded to the University of Georgia to develop a waveguide immunoassay for the pathogen Yersinia Pestis. The initial work by the University of Georgia /Georgia Tech consortium has shown that a waveguide sensor can serve as the basis for detection of bacteria in food matrices. CFSAN and the FDA have an increasing need for access to technologies that can rapidly assess the presence of bacteria and toxins in foods. The waveguide system developed by the Georgia consortium should be further considered by CFSAN in its overall program to develop multiplexed sensor systems for selective detection of bacteria and toxins in foods. At present, no commercial entity can offer an optical sensor with multi-analyte capabilities that has been demonstrated to selectively detect bacteria in food matrices. Therefore, CFSAN must continue to work with the University of Georgia/Georgia Technical Research Institute consortium to research the capabilities of this sensor system. The objective of the contract is to have a waveguide immunoassay system constructed, to deliver the system to CFSAN with software, hardware and reagents necessary to conduct the validation of its proper function at CFSAN with Salmonella enterica spp, to develop a selective assay for Salmonella with antibodies chosen in consultation with CFSAN, to develop surface chemistries and methodologies necessary for the adaptation of the assay to additional bacterial targets, viruses, protein toxins and seafood toxins, and to perform validation studies to demonstrate the robustness of these applications. The contractor will be required to 1) produce a portable waveguide immunoassay system that will consist of hardware and software necessary to evaluate the detection and quantification of bacteria in food matrices; 2) provide user training upon system delivery so that Government personnel can reproduce the delivery performance test with Salmonella enterica spp; 3) develop a surface chemistry and an assay for the selective detection of a strain of Salmonella enterica spp in test portions which may also contain up to four microorganisms, such as E.coli, L. monocytogenes, C. jejuni, Campylobacter or other food borne pathogens; 4) develop a number of surface and surface chemistry techniques to expand the capabilities for selective multi-analyte detection in foods. The Government intends to solicit and negotiate with the Georgia Tech Applied Research Corporation as the only source under the authority of FAR 6.302. This is not a Request for Proposals. Sources interested in this requirement must provide a statement of capabilities in sufficient detail to determine if the requirements of this synopsis can be met. The North American Industry Classification System (NAICS) code is 54710. Responses must be in writing and must be received within fifteen (15) calendar days from the date of this announcement. A determination by the Government not to compete the proposed requirement based on responses from this notice is solely within the discretion of the government. Information received will normally be considered solely for the purposed of determining whether to conduct a competitive procurement. See Numbered Note 22.
- Record
- SN01351681-W 20070727/070725220634 (fbodaily.com)
- Source
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