66 -- Rapid, automated, multi-analyte test system

The United States Department of Agriculture (USDA), Food Safety and Inspection Service (FSIS) is hereby soliciting information about potential sources capable of providing the agency with a rapid, automated, multi-analyte test system to identify classes of antimicrobial drugs such as tetracyclines, beta-lactams, aminoglycosides, macrolides, fluoroquinolones, cephalosporins, phenicols, and sulfonamides. The system will be used to identify those animals whose tissues will be tested by chemical methods to quantify and confirm specific compounds in the classes identified. The product will be used to detect controlled or banned residues in food animal tissues as provided under the code of Federal Regulations Title 21 Parts 530 and 556, Title 40 and the Federal Meat Inspections Act, the Poultry Products Inspection Act and the Egg Products Inspection Act. Last calendar year, FSIS ran approximately 10,000 tests for antibiotic residues. Although FSIS cannot identify how many tests will be needed in the future, this figure should be used as a guide when providing price estimates in response to this sources sought synopsis. (1) Description of Requirement: The automated test system shall screen for antimicrobial residue classes in tissues or tissue extracts. Specific residue classes to be identified for further testing shall include those in the sulfonamide group, tetracyclines, beta-lactams, aminoglycosides, fluoroquinolones, cephalosporins, phenicols, macrolides, and other antimicrobials. The test must differentiate each of these drug classes when present in food animal tissue. The test system must have the capability to perform multi-analyte testing on single individual samples. The test system must have the ability to detect down to the part-per-billion (ppb) level for select drugs. The Contractor will be responsible for Quality Assurance functions of the project. Contractor personnel must possess extensive knowledge of laboratory procedures and laboratory safety practices. (2) Specific Requirements: The potential suppliers will need to describe the method used to determine the limits of detection, and the limits of detection for each drug tested. A complete description of the procedure, along with estimated times required per analysis, should also be submitted. (3) Interested respondents should be aware that they may be required to provide test validation data based on the following parameters. Four months will be provided to produce such a data package. The test system must be validated for use with the tissue matrices used for FSIS regulatory testing, which are: liver, kidney and muscle tissues or tissue extracts from cattle, swine, poultry and eggs. Test system validation results must be provided to FSIS. FSIS Regulatory testing information can be located at the following websites: Chemistry lab guidebook- http://www.fsis.usda.gov/science/Chemistry_Lab_Guidebook/index.asp. Micro lab guidebook- http://www.fsis.usda.gov/Science/Microbiological_Lab_Guidebook/index.asp (4) Response Requirements-Technical: Interested respondents having the specialized capabilities to meet the above requirement should submit a capability statement indicating the ability to perform all aspects of the effort described herein. Discuss the proposed testing equipment, procedures, methods, options or technologies you believe would benefit FSIS. The respondent needs to submit a description of the protocol used to determine the limits of detection, which should reflect tests run in the appropriate matrices (not water or buffer). Submissions shall not exceed ten pages (8 a half X 11) not including test data. Information submitted to FSIS in response to this Sources Sought will be treated as strictly proprietary unless otherwise indicated. If validation data should be required it must include sensitivity, specificity, limits of detection, limits of quantitation, ruggedness and method uncertainty. The test must be on a scientifically recognized platform such as a 96-well plate or biochip format and be fully automated for ease of use. The test system must be such that one person can analyze one or more batches of samples within a standard work day, or automated for overnight analysis. The respondent shall generate or submit data on a range of drugs from each compound class. As mentioned above the respondent should plan on completing the data package in four months if so required. It is emphasized that this Sources Sought notice is for information only and is NOT to be construed as a commitment by the Government to enter into a contractual agreement, nor will the Government pay for information solicited. No solicitation exists; therefore do not request a copy of the solicitation. 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 the responses received; however, the information will be used in FSIS?s assessment of capable sources. (4) Pricing: Cost will be reviewed along with technical ability. Respondents are asked to provide pricing information. (5) Additional Information: If you are a source capable of providing such a test, please respond to this Sources Sought. The NAICS Code associated with this notice is 334516 and the size standard is 500 employees. Responses must include the following: name and address of firm; contact and phone number, size of business; number of employees; whether they are large, small, small disadvantaged, 8(a), HUBZone, woman-owned, Historically Black College or University, and/or service-disabled veteran-owned. Responses should be submitted by 5:00 PM Eastern Time, December 20, 2006. Send 1 original and 1 copy. Questions concerning this announcement may be submitted via email only, no telephone inquires will be honored. Faxed responses are not permitted. Responses may be sent by mail or via email. It is the responsibility of the respondent to verify the response was received.