SOLICITATION NOTICE
B -- Enzyme-Linked Immunosorbant Assay (ELISA)
- Notice Date
- 8/14/2008
- Notice Type
- Presolicitation
- NAICS
- 611310
— Colleges, Universities, and Professional Schools
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 6120 Executive Blvd., EPS Suite 600, Rockville, Maryland, 20852
- ZIP Code
- 20852
- Solicitation Number
- NCI-80182-NG
- Archive Date
- 9/13/2008
- Point of Contact
- Ashley L. Virts, , Malinda L Holdcraft,, Phone: (301) 402-4509
- E-Mail Address
-
virtsa@mail.nih.gov, holdcram@exchange.nih.gov
- Small Business Set-Aside
- N/A
- Description
- The National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), Occupational and Environmental Epidemiology Branch (OEEB), plans to procure on a sole source basis, the Enzyme-Linked Immunosorbant Assay (ELISA) test of H. pylori, cag A status, and pepsinogen levels and stomach cancer risk in the Cohort Consortium with Karolinska Institute, Department of Medical Epidemiology; 281, S-171 77, Stockholm, Sweden. The services herein are being procured in accordance with the simplified acquisition procedures authorized by FAR Part 13.106-1 (b) (1). The North American Industry Classification System Code is 611310 the business size standard is 6.5 M employees. The period of performance for this procurement is September 15, 2008 through September 14, 2009. The purpose of the procurement is to perform Enzyme-Linked Immunosorbant Assay (ELISA) tests for levels of pepsinogen I, pepsinogen II, and H. pylori whole cell antibodies, and immunoblot assays for cagA status, in serum or plasma of stomach cancer cases and healthy controls in a study nested within participating cohorts in the Cohort Consortium. Helicobacter pylori infection is a well-established risk factor for stomach cancer. The cagA strains of H. pylori are known to be particularly virulent and associated with a greater excess risk of stomach cancer. Infection with gastric pathogen leads to progressive pathologic changes from atrophy to dysplasia and ultimately cancer. Levels of pepsinogens in the stomach have are a good indicator in the presence of gastric atrophy and an informative predictor of subsequent gastric cancer development. Together, markers of H. pylori infection and pepsinogen levels form the foundation of gastric cancer epidemiologic research. Evaluation of other potential gastric cancer risks and mechanisms of progression must take into consideration of H. pylori infection and gastric atrophy as indicated by pepsinogen levels. The most common test for H. pylori infection used in epidemiologic studies is the ELISA method measuring antibody titers to whole cell and cagA strains in serum or plasma. Recently, an immunoblot method has been developed which is more sensitive in detecting cagA strains. The ELISA assay is also used for measuring levels of pepsinogen I and II in serum or plasma. The contractor shall perform the following tasks. 1.Receive 2164 frozen serum/plasma samples shipped from a NCI-designated repository. Confirm receipt of each sample and report to NCI immediately the condition of samples at arrival. 2.Store the samples immediately in -80C freezer until ready for assays. 3.Measure the levels of pepsinogen I and pensiongen II on all 2164 serum/plasma samples received from NCI, using the ELISA method. 4.Measure antibodies to H. pylori whole cell on 1574 of the serum/plasma samples designated by NCI, using the ELISA method. 5.Measure the status of infection by cagA strains of H. pylori on 968 serum/plasma samples designated by NCI, using the immunoblot method. 6.Deliver the results to NCI in Excel format via email within two weeks of completion of each assay. Karolinska Institute is a world class institute in studying gastrointestinal cancers, and Dr.Weimin Ye, who directs the laboratory at Karolinska Institute, is an international expert in stomach cancer research and analysis of H. pylori and pepsinogens. He uses the most advanced immunoblot method in detecting infection with cagA strains of H. pylori in serum and plasma samples. This method is not currently used in other research or commercial laboratories for large studies, as is proposed in this contract. The formation of the NCI-lead Cohort Consortium led DCEG iinvestigators to expand the stomach cancer study to other cohorts in the Consortium. The large pooled data will allow for more refined and definitive analysis of gastric cancer risks, including the association with H. pylori, cagA, and pepsinogens. For comparability of results from SWHS with those of the other cohorts, the assays need to be conducted in the same laboratory to remove any laboratory variables that could be impossible to control otherwise. Dr. Ye has extensive collaboration in China and other Asian countries, and has first hand knowledge about sample conditions and the type of H. pylori infection in Asia, which are different from those of the U.S. This experience is critical for handling the samples in the proposed contract which includes samples from Asian countries and the U.S. There is no other laboratory known to the NCI that can perform the analysis outlined in the procurement. This is not a request for competitive quotation. However, if any interested party believes it can meet the above requirement, it may submit a statement of capabilities. The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow the researcher to determine if the party can meet this requirement. One (1) original and one (1) copy of the capability statement must be received in the contracting office by 11:00 a.m. ET on August 29, 2008. All questions must be in writing and can be faxed to 301-402-4513 or sent via email to Malinda Holdcraft: holdcram@exchange.nih.gov. It is the vendor’s responsibility to ensure questions have been received. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. No collect calls will be accepted. In order to receive an award, contractor must have valid, updated registration and certification in the Central Contractor Registration (CCR) and the Online Representations and Certifications Application (ORCA). Please reference NCI-80182-¬NG on all correspondence.
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