SOLICITATION NOTICE
66 -- EVALUATION OF ZEPTOMARK PPS SYSTEM FOR ANALYSIS OF TOXINS IN FOOD
- Notice Date
- 8/12/2004
- Notice Type
- Solicitation Notice
- NAICS
- 339111
— Laboratory Apparatus and Furniture Manufacturing
- 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
- ZIP Code
- 20857-0001
- Solicitation Number
- F6104004
- Response Due
- 8/24/2004
- Archive Date
- 9/8/2004
- Point of Contact
- Sharon Savage, Management Analyst, Phone 301-827-1509, Fax 301-827-6854, - Leonard Grant, Contracting Officer, Phone (301) 827-7173, Fax (301) 827-7101,
- E-Mail Address
-
SES@CDRH.FDA.GOV, lgrant@oc.fda.gov
- Description
- This is a combined synopsis/solicitation for commercial items or services IAW with the format in FAR Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation and a written solicitation will not be issued. This solicitation is issued as a Request for Quote (RFQ) No. F6104004. The solicitation clauses and provisions are those in effect through Federal Acquisition Circular 97-27. The NAICS Code is 339111. The Food and Drug Administration intends to award a non-competitive, sole source purchase order to SciMarket Strategies, 318 West Emerson Street, Melrose, Massachusetts for evaluation of a Multianalyte Microarray System. SciMarket is the only party capable of evaluating this new approach for measurement of many toxins simultaneously. Vendor shall perform the following statement of work: The Instrumentation and Biophysics Branch (IBB) is involved in research and development of new approaches and assays for the identification and detection of toxic substances in food. Of particular concern are protein toxins such as staphylococcal enterotoxins, which may pose not only a food safety risk, but also a terrorism threat. Among the many approaches that are being considered are multianalyte microarray systems and assays, which employ multiple antibodies to simultaneously extract and detect more than one toxin in a complex matrix. Although there are many academic research efforts in this area, we would like to assess the capabilities of a commercial instrument based on the microarray approach. This instrument is produced by SciMarket Strategies business partner, Zeptosens-AG and employs a fluorescence based microarray/assay system using Planar Waveguide Technology. The approach undertaken by using the Zeptosens instrument is that it allows for the simultaneous detection of more than one toxin at part-per-million levels and lower, which are requirements for any such system the FDA would eventually employ. This is important new detection technology that may be capable of fulfilling long term needs for the agency in the broad areas of food safety and security. Modifications of the current multianalyte assay, with input from the FDA (IBB), could address future needs. SciMarket Strategies has worked with Zeptosens using its system for studies on the multiplexed detection of food contaminants,but it has not yet developed specific assays for the target toxins in which the FDA is interested. The FDA requires that a custom assay be developed and evaluated for toxins chosen by the FDA and in matrices of interest to the FDA. Evaluation of the instrument with toxins and matrices of interest to the FDA, under FDA guidance, will be the most effective way to determine the efficacy of this approach. The following are the requirements for the evaluation. 1) A simultaneous assay will be developed for the following toxins: staphylococcal enterotoxins A & B, E. coli shiga toxins type 1 & 2, cholera toxin, tetrodotoxin, saxitoxin and aflatoxin. 2) The assay will be developed for use with three matrices: water (or buffered water), apple juice and milk. 3) SciMarket Strategies will deliver two reports as the product of this evaluation. The first (Phase I) report will describe the performance characteristics of the multianalyte array in water (or buffer). The second (Phase 2) report will be a final report detailing the performance of the multianalyte Assay for the toxins in two food matrices, milk and apple juice. 4) Requirements for Phase I report: a. microarray layout design; b. test and select assay reagents; c. adjust individual assay dynamic ranges; d. test individual assay performance in aqueous buffer, milk and apple juice; e. provide a diagram describing sample preparation procedure; f. provide a diagram describing all analytical steps e.g. incubation, washing, addition of a reagent etc.; g. test multiplexed assay performance in aqueous buffer; 5. Methods for characterizing performance of assays described in part 4 above: a. Show calibration curve for analytes using analyte standard solutions in both, the buffer, milk and fresh apple juice; b. Limit of detection (LOD) for the individual analytes determined according to the following procedure: prepare 10 independent sample blanks from whole fresh apple juice according to developed sample preparation procedure. Measure sample blanks once on the same day using identical analytical conditions by the same operator using the same equipment. Calculation of LOD: determine the mean blank value and standard deviation; calculate the concentration at signal level of the blank signal + 3 x standard deviation (blank) us-ing the calibration curve; c. Carry out analysis of analytes in model samples prepared by spiking of whole milk and apple juice (prepare fresh samples each measuring day); d. Calculate repeatability expressed as standard deviation and coefficient of variation for the individual analytes; e. Provide results of analysis (average and standard deviation); f. Report working range for assay; g. Report limit of quantification for assay 6. Requirements for Phase II report: a. optimize multiplexed assay conditions (all analytes simultaneously measured); b.test performance and validate multiplexed assay in milk and apple juice samples; c. methods for characterizing performance of multiplexed array will be the same as those discussed in part 5; 7. The FDA will supply SciMarket Strategies with all of the reagents associated with each assay, including the toxin itself and antibodies associated with the immunoaffinity capture of the toxin. Where it is more efficient for SciMarket Strategies to procure antibodies or toxins directly, FDA will provide appropriate sources. The FDA will provide all of the necessary procedure for use of the antibodies (surface binding, etc). The FDA will also provide data regarding the evaluation of standard ELISA based methods for the same toxin, e.g. the tests against which the multiarray methods will be evaluated. This is not a formal request for quotes. However, the evaluation of other offers and any award decision will be made on a best value basis. The FDA intends to make an award immediately after the response date of this notice. The following FAR clauses shall apply to the solicitation: 52.212-1 Instructions to Offerors-Commercial; 52.212-2 Evaluation-Commercial Items; 52.212-3 Offeror Representations and Certifications; 52.214-4 Contract Terms and Conditions-Commercial Items; and 52.232-33 Electronic Funds Transfers. All responsible sources that can provide and meet the above requirements shall submit written quotations by the due date referenced above. All questions should be submitted in writing via email to sharon.savage@fda.hhs.gov or fax to (301) 827-7039. FAR provisions can be found at the following website: http://www.arnet.gov.
- Place of Performance
- Address: Room BE-013, HFS-717, 5100 Paint Branch Parkway, College Park, MD
- Zip Code: 20740
- Country: US
- Zip Code: 20740
- Record
- SN00642277-W 20040814/040812211802 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
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