SOLICITATION NOTICE
66 -- Food Allergen Multiplex Assay - Package #1
- Notice Date
- 6/26/2013
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 334519
— Other Measuring and Controlling Device Manufacturing
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 3900 NCTR Road, HFT-320, Bldg 50 | Rm 421, Jefferson, Arkansas, 72079, United States
- ZIP Code
- 72079
- Solicitation Number
- FDA-SOL-1113543
- Archive Date
- 8/7/2013
- Point of Contact
- Christopher R. McGucken, Phone: 3018277161
- E-Mail Address
-
christopher.mcgucken@fda.hhs.gov
(christopher.mcgucken@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Attachment B (Past Performance Questionnaire) Attachment A (SF 33) Full Solicitation (Per FAR 15.204-1) The detection of undeclared food allergens and gluten are necessary for the regulatory enforcement of the Food Allergen Consumer Protection Act of 2004 (FALCPA) and the Gluten-Free Regulation currently under review by FDA senior management. The methods currently being employed by the FDA involve the use of analyte specific ELISA technology to detect seven of the eight major food allergens; namely, egg, gluten/wheat, milk, peanut, tree nut (almond, hazelnut, and walnut), crustacean shellfish, and soy protein. These antibody-based methods display limits of detection (LOD values) between 0.4 m g/mL and 2 m g/mL and have been demonstrated to be reliable in multi-laboratory validation studies. However, before these analytical methods can be used, one must first know what food allergen to test for. Thus, when the specific tree nut is not known it becomes necessary to test the sample for each tree nut separately, a process requiring the purchase of multiple ELISA test kits and the preparation of multiple extracts to meet the requirements of each test kit. Further, due to the possibility of cross-reactivity by the antibodies to homologous proteins, the protocol requires that all results be confirmed using two different ELISAs. This is an expensive and time consuming process and has on several occasions necessitated that samples not be screened for all suspect food allergens due to the cost of the individual ELISA test kits or the lack of ELISA availability for some allergens (e.g., Brazil nuts, cashews, and pine nuts). An approach currently being evaluated as a substitute to ELISAs involves the use of field-deployable dipsticks whereby a single extract is analyzed using multiple dipsticks. This process reduces the cost and time per analysis and enables the screening for a wider range of food allergens (e.g., all of the allergens possible using ELISA technology plus Brazil nuts, cashews, coconuts, macadamia nuts, and pistachios). However, the sensitivity of the dipsticks vary with the allergen and are typically 10-fold less sensitive than ELISA technology. In-house validation studies indicate that the LOD values for tree nuts, peanuts, and soy are > 10 m g/mL and thus may not meet regulatory needs that favor target levels of 1 – 5 m g/mL. An alternative antibody-based technology that has shown a high level of reliability with sensitivities comparable to or better than ELISAs is xMAP technology. This bead-based technology has been demonstrated to be reliable in the detection of various proteinaceous toxins in foods with a throughput exceeding ELISA test kits since each analytical sample can be simultaneously screened for multiple analytes and subjected to a confirmatory test process. Further, by employing antibodies used in ELISA test kits and dipsticks, the properties of the antibodies are already known. This eliminates some of the evaluative processes necessary before a method can be adopted and makes the method compatible with other methods currently being employed by the food industry and contract labs.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/FDA-SOL-1113543/listing.html)
- Record
- SN03100101-W 20130628/130626234942-73776c8cf58468127e397787b7564124 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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