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H -- Simian Virus 40 (SV40) in non-Hodgkin's Lymphoma (NHL)

Notice Date
Notice Type
Contracting Office
Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Research Contracts Br., 6120 Executive Blvd. EPS Suite 600, Rockville, MD, 20852
ZIP Code
Solicitation Number
Response Due
Archive Date
Point of Contact
Deborah Moore, Purchasing Agent, Phone (301) 402-4509, Fax (301) 402-4513, - Renita Smith, Contract Specialist, Phone 301-496-8612, Fax 301-480-0241,
E-Mail Address
dm170b@nih.gov, rs442i@nih.gov
This is a combined synopsis/solicitation prepared in accordance with the Federal Acquisition Regulation Part 13, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation, and a separate written solicitation will not be issued. This solicitation, No. NCI-RFQ-30042-NV will include all applicable provisions and clauses in effect through FAR FAC 2001-13. It is anticipated that two awards will be made from this solicitation. The North American Industrial Code is 541380 and the business size standard is 6M. However, this solicitation is not set-aside for small businesses. Background: The National Cancer Institute (NCI) proposes to enter into a agreement with two laboratories to use serological methods to study the role of simian virus 40 (SV40) in non-Hodgkin?s lymphoma (NHL), in a study entitled, ?SV40 and non-Hodgkin?s lymphoma: a case control study.? SV40 was an inadvertent contaminant of poliovirus vaccines widely administered in 1955-62 in the U.S. Of concern, SV40 causes a variety of tumors when injected into newborn laboratory animals, including brain tumors, mesotheliomas, osteosarcomas, and notably, NHL. The possibility that SV40 infections, arising through vaccinations or other routes, cause a substantial fraction of NHLs was recently raised by two U.S. reports, describing the detection of SV40 DNA in 33-50% of NHLs (1,2). Recent work has demonstrated the value of virus-like particle (VLP) enzyme immunoassays (EIAs) for the detection of SV40 infection in humans. Specifically, a recent publication documented the sensitivity and specificity of an SV40 VLP assay for detection of SV40 infection (3). The EIA format is particularly appropriate for epidemiological studies, since it can be performed inexpensively on a large scale, using small volumes of sera. Similar VLP EIAs for the human polyomaviruses BK and JC allow for the evaluation of cross-reactive antibodies in the same serum samples. An SV40 VLP EIA was used in a study of NHL in Spain (4). NCI will study the association between SV40 and NHL, by measuring SV40 antibodies in subjects from the NCI-SEER Case-Control Study of NHL. This case-control study includes serum on approximately 800 HIV-uninfected NHL cases and 700 age-matched HIV-uninfected population controls. This study will be the first U.S. population-based case-control study of SV40 and NHL. NCI proposes to perform this testing using VLP EIAs for SV40, BK, and JC viruses. NCI seeks two independent laboratories to perform this testing, in order to compare the consistency of results between laboratories. Base Requirement: The purpose of this study is to compare SV40 antibody prevalence in NHL cases and controls. Independently and not as an agent of the Government, the Contractor shall furnish services, qualified personnel, materials, and facilities as needed to perform this requirement. Serum samples will be supplied by the NCI. Contract Requirements: 1. The contractor shall perform VLP enzyme immunoassay measurements on 1500 serum samples from NHL cases and control. The contractor will perform VLP measurements separately for the three polyomaviruses SV40, BK, and JC. All samples will be tested in duplicate, and samples demonstrating coefficients of variation greater than 20% will be repeated. 2. The contractor shall send to NCI the results of these tests in electronic format (Excel file or text file), along with the results of negative and positive controls from the corresponding assay runs. Results will consist of the individual optical density readings from the enzyme immunoassay runs and a score of each result as positive or negative. 3. The contractor shall send an invoice to NCI, specifying the samples tested and tests performed. Reporting Requirements and Deliveries: Study 1 of 2: due 6 weeks from start of order - Pilot study results. NCI will randomly select 300 sera from NHL cases and controls and include an additional four sera from SV40-positive monkeys as positive controls. The contractor shall perform SV40 VLP enzyme immunoassay testing in duplicate on these samples. Deliverable: SV40 VLP enzyme immunoassay results for these samples, in electronic format (Excel file or text file), to be sent by email to NCI. Study 2 of 2: due 5 months from start of order - Main study results. The contractor shall perform SV40 enzyme immunoassay testing on the remaining 1200 cases and controls, in duplicate. The contractor shall perform BK and JC enzyme immunoassay testing on all 1500 cases and controls, in duplicate. Deliverable: Enzyme immunoassay results as specified, in electronic format (Excel file or text file), to be sent by email to NCI. References (1) Vilchez RA, Madden CR, Kozinetz CA, Halvorson SJ, White ZS, Jorgensen JL et al. Association between simian virus 40 and non-Hodgkin lymphoma. Lancet 2002;359:817-23. (2) Shivapurkar N, Harada K, Reddy J, Scheuermann RH, Xu Y, McKenna RW et al. Presence of simian virus 40 DNA sequences in human lymphomas. Lancet 2002;359:851-2. (3) Viscidi RP, Rollison DE, Viscidi E, Clayman B, Rubalcaba E, Daniel R et al. Clin Diagn Lab Immunol 2003;10:278-85. (4) de Sanjose S, Shah KV, Domingo-Domenech E, Engels EA, Fernandez de Sevilla A, Alvaro T et al. Lack of serological evidence for an association between simian virus 40 and lymphoma. Int J Cancer 2003;104:522-4. EVALUATION AND CRITERIA: The technical portion of quotations will receive paramount consideration in selecting a vendor. However, price will also be a significant factor in the event that two or more vendors are determined to be essentially equal following the evaluation of technical factors. The technical portion of quotations shall be evaluated based on the following technical evaluation criteria: 1) Technical approach: a. Adequacy of production methods and quality control for SV40, BK, and JC VLPs (10 points); b. Adequacy of methods to perform VLP enzyme immunoassays, including appropriateness of techniques described in the laboratory protocol, incorporation of positive and negative laboratory controls, and quality control procedures (10 points); 2) Experience: a. Past experience with SV40, BK, and JC VLP enzyme immunoassays (30 points); b. Past experience with other serological assays (5 points); c. Experience with large-scale testing of human samples in epidemiological research (5 points); 3) Facilities: a. Availability of VLPs and other reagents for enzyme immunoassays (10 points); b. equipment to perform large-scale testing of human samples (10 points); c. Ability to transmit assay results in electronic format (10 points); 4) Personnel: a) Adequacy of personnel to perform enzyme immunoassays (10 points). This solicitation incorporates the provisions at FAR Clause 52.213-4, Terms and Conditions ? Simplified Acquisitions. Offerors must submit a complete copy of Representations and Certifications, including the provision for the DUNS Number (FAR Clause 52.204-6), with their offer. The Representations and Certifications must be signed by an authorized representative of the offeror. Full text copies of the Terms and Conditions and the Representations and Certifications can be obtained from Debbie Moore, Purchasing Agent on (301)402-4509 or by fax on (301)402-4513. In addition, Offerors must provide an original and two copies of a written technical proposal, descriptive literature, resumes of personnel, information, and other materials in sufficient detail to demonstrate that they can perform the foregoing requirements as determined by the evaluation criteria herein. Offerors shall also submit a completed SF18, signed by an individual authorized to bind the organization, and a cost/price quotation. Offers/Quotations and all other materials must be submitted to Debbie Moore at the listed address. Offers that fail to furnish the required information or reject the terms and conditions of the solicitation may be excluded from consideration. Offers/Quotations and related materials must be received in this office by 2:00 PM (local Washington, D.C. time) on May 19, 2003. All questions must be in writing and can be faxed (301) 402-4513 or emailed to dm170b@nih.gov . It is the vendor?s responsibility to call (301) 402-4509 to insure questions have been received. No collect calls will be accepted. Please cite the solicitation number, NCI-RFQ-30042-NV, on your quotation package.
SN00314144-W 20030501/030429213336 (fbodaily.com)
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