SOURCES SOUGHT
87 -- Biological Product
- Notice Date
- 8/8/2011
- Notice Type
- Sources Sought
- NAICS
- 325414
— Biological Product (except Diagnostic) Manufacturing
- Contracting Office
- Department of Agriculture, Food Safety and Inspection Service, Procurement Management Branch, 5601 Sunnyside Avenue, Mail drop 5230, Beltsville, Maryland, 20705
- ZIP Code
- 20705
- Solicitation Number
- 523825
- Archive Date
- 9/1/2011
- Point of Contact
- Brenda Barber, Phone: 3015043996
- E-Mail Address
-
brenda.barber@fsis.usda.gov
(brenda.barber@fsis.usda.gov)
- Small Business Set-Aside
- N/A
- Description
- The Food Safety and Inspection Service (FSIS) is the public health agency in the U.S. Department of Agriculture responsible for ensuring that the nation's commercial supply of meat, poultry, and egg products is safe, wholesome, and correctly labeled and packaged. The FSIS non-O157 STEC method was published as MLG 5B.00 on the FSIS web site on Oct 18, 2010 and can be accessed at http://www.fsis.usda.gov/PDF/Mlg_5B_00.pdf The United States Department of Agriculture (USDA), Food Safety and Inspection Service (FSIS) is seeking sources capable of providing the agency with the development of a reliable, simple and rapid latex agglutination test (LAT) assay using polyclonal or monoclonal antibodies. The latex agglutination assays must have high specificity to the 6 (six) Shiga toxin-producing Escherichia coli (STEC) serogroups, O26, O45, O103, O111, O121 and O145. The initial application package should detail how the organization intends to prepare the polyclonal or monoclonal antibody. Additionally, the Agency intends to include the use of latex agglutination tests, in the next iteration of MLG Chapter 5B to help rapidly identify isolated colonies as belonging to one of the six Shiga toxin-producing Escherichia coli serogroups of interest. Kits shall be capable of specifically identifying the following E. coli serogroup O antigens: O26, O45, O103, O111, O121 and O145. Further, the Kit component shelf life shall be a minimum of 6 months when stored at 2-8 degrees C. The Kit components shall include the following materials: •Sufficient volume of reagents and consumables to perform a minimum of 50 tests •Six vials, each containing test latex particles coated with IgG antibodies specific to one of the six Shiga toxin-producing Escherichia coli O groups •One vial containing Control latex particles coated with IgG antibodies from pooled normal serum from same species as Test IgG antibodies •Six vials, each containing Positive Control suspension of formalin-killed E. coli from one of the six specific Test serogroups •One vial containing Negative Control suspension of formalin-killed E. coli from an E. coli serogroup that is not one of the six Test serogroups •Disposable agglutination slides, stirring sticks, and an instruction sheet including protocol, specifications of bead storage and stability, any additional materials to be supplied by the user, factors that affect product performance (sample types, etc.) and troubleshooting information. •Identifiable lot number(s) and a certificate of analysis that documents the performance characteristics for the production lot(s) of the kit reagents. Performance characteristics of each lot of test kit reagents shall be assessed and documented (in the certificate of analysis) against each of the Test E. coli O group "Reference" strains. Kit reagents shall meet the following performance criteria. •Test latex reagent sensitivity shall be ≥ 99% when tested against the Reference O group strains. •Ogroup •Test latex reagent specificity shall be ≥ 95% when tested against the Reference O group strains outside of the six Shiga toxin-producing Escherichia coli O groups of interest. If you are a source capable of providing such tests, please respond to this Sources Sought Synopsis with your company information, along with your Firm's capability statement. Respondents are asked to identify their business size in their response to this sources sought synopsis. The NAICS Code associated with this notice is 325414 and the size standard is 500 employees. This notice is not a request for proposals and the Government does not intend to pay for information submitted. Respondents will not be notified of the results of the evaluation of the information they provide. No contract award will be made on the basis of responses received; however, the information will be used in FSIS's assessment of capable sources. Responses should be submitted by 4:00pm, August 17, 2011. Faxed responses are not permitted. Questions concerning this announcement may be submitted via email only, no telephone inquires will be honored. All responses may be submitted by e-mail to brenda.barber@fsisu.sda.gov; or by mail to Brenda Barber at USDA, FSIS, ASD, 5601 Sunnyside Avenue, Maildrop 5230, Beltsville, MD 20705-5230.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USDA/FSIS/AAS/523825/listing.html)
- Record
- SN02526052-W 20110810/110808235801-bbbbbd5c8901538ec033656ac727ce37 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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