SOLICITATION NOTICE
99 -- Abrin Test Strips and Elisa Kits
- Notice Date
- 6/30/2010
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- REQ1073422
- Archive Date
- 7/27/2010
- Point of Contact
- Mary Rose A. Nicol, Phone: 3018277183
- E-Mail Address
-
MaryRose.Nicol@fda.hhs.gov
(MaryRose.Nicol@fda.hhs.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6, simplified acquisition procedures and the resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 05-30. This announcement constitutes the only solicitation and a written solicitation will not be issued. This combined synopsis/solicitation, NAICS code 541711, is to notify contractors that the government intends to issue a Firm Fixed Price Contract in accordance with FAR Part 13.106 for the following specifications, under the simplified acquisition procedures. This action is designated as a 100% small business set-aside. Prospective offerors are responsible for downloading the solicitation and any amendments. It is the offeror's responsibility to monitor the FedBizOpps website for the release of any amendments to this solicitation. The Government reserves the right to award a contract without discussions if the Contracting Officer determines that the initial offer(s) is/are providing the Best Value and discussions are not necessary. This solicitation is issued as a Request for Quotes (RFQ). FDA intends to issue a firm-fixed price purchase order for the Abrin Elisa Kits and Abrin Bio-Threat Kits tht meets or exceed the following specificaitons: SPECIFICATIONS: ABRIN TEST: FOR THE RAPID QUALITATIVE DETERMINATION OF ABRIN TOXIN. The Elisa Kits must be Brand Name or Equal to: The ‘Tetracore Ricin ELISAs (numbers TC-4001-002, TC-4002-002, TC-4003-001, and TC-4004-001) The Abrin Bio-Threat Kits must be brand name or equal to the ‘Ricin BioThreat Alert® Kit (catalogue number TC-8008-025). USE: The Abrin test strip should be a hand-held biological device for Abrin Toxin, which is produced by abrus precatorius. It should be intended for use in the field for performing rapid analysis of unknown potential biological threats contained in samples collected from the environment. The Abrin test strip is NOT a diagnostic device. This device is not intended for testing on samples collected from humans or intended for any medical use. The lateral flow devices (LFDs) should enable the rapid, less than 15 minutes, detection of Abrin in various environmental samples. LFDs must employ antibodies which tightly bind compounds referred to as antigens. The high specificity and affinity of antibodies for their respective antigens must enable them to detect specific antigens at concentrations well below 1 ppm in the presence of other compounds in vast excess. The ELISA kit must employ a commercially available enzyme linked immunosorbent assay (ELISA) for the detection of Abrin in environmental samples. This ELISA must be successfully applied to the detection of ricin in juices (apple, orange, pineapple, prune, V-8), milk (2%), infant formula (soy-based), soda (cola), produce (grapes, lettuce, grapefruit), breads (wheat bread, ‘everything' bagel, tortilla), milk chocolate, sunscreen, body gel/lotion, and shampoo with conditioner at levels less than 1 mg/kg (< 1 ppm). TESTING PRINCIPALS: ELISAs must employ antibodies, proteins which tightly bind compounds referred to as antigens. The high specificity and affinity of antibodies for their respective antigens must enable them to detect specific antigens at concentrations well below 1 ppm in the presence of other compounds in vast excess. LFDs must provide a rapid qualitative test to detect the presence of Abrin Toxin. The test should utilize a combination of monoclonal and polyclonal antibodies to selectively detect the presence of biological threat agents in aqueous samples. The assay must be conducted by the addition of sample into a test device Sample Port and observing the formation of colored labeled antibody, than migrates via capillary action along the membrane. A positive sample should react with the agent-specific labeled antibody conjugate and forms a line in the S (sample) Window. In the absence of the specific agent, no line will develop, suggesting a negative result. To serve as a control for the procedure, a colored line in the C (control) Window should always appear regardless of the presence or absence of specific biological agents in the sample. The test should be invalid if no colored line appears in the C (control) Window. VALADATION: These methods will be validated by the FDA and acceptable for uses that meet the specifications for the rapid detection of the stated toxin. Please submit your pricing as follows: Item 1 TC-4029-002 Abrin Elisa Kits at 60 each unit cost $_______ Total $__________ Item 2 TC-8011-025 Arin Bio-Threat Kits at 60 each unit cost $_______ Total $___________ Item 3 Shipping Cost $__________________ Total cost $_____________________________ CCR: Vendors must be registered in the Central Contractor Register (CCR) prior to the award of a contract. You may register by going to www.ccr.gov. You will need your Dun & Bradstreet number and banking information. QUESTIONS DEADLINE: All questions are to be submitted via email to maryrose.nicol no later than July 8, 2010 2:00 pm EST. QUOTATIONS DUE: All quotations are due, via email to: maryrose.nicol@fda.hhs.gov, no later than 5:00 pm, EST on July 12, 2010. PROVISIONS and CLAUSES: The provision at FAR 52.212-1, Instructions to Offerors Commercial Items applies to this solicitation. The following agenda has been attached to this provision: None. Offerors shall include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications Commercial Items. The clause at FAR 52.212-4, Contract Terms and Conditions, Commercial Items applies to this acquisition. The following agenda has been attached to the clause: None. The clause at FAR 52.212-5 Contract Terms and Conditions Required to Implement Statues or Executive Orders, Commercial Items applies to this acquisition. The following FAR clauses cited are applicable: FAR 52.217-8, FAR 52.222-26, FAR 52.222-35, FAR 52.222-36, and FAR 52.232-33, FAR 52.217-9 Option to Extend the Term of the Contract. Clauses and provisions are incorporated by reference and apply to this acquisition. Responses to this notice must be sent via email to maryrose.nicol@fda.hhs.gov. No phone calls will be accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/REQ1073422/listing.html)
- Place of Performance
- Address: Rockville, Maryland, United States
- Record
- SN02193148-W 20100702/100630235351-2c88039ceff5cd5cb991a289d73ace9d (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |