National Institutes of Health, National Heart, Lung, and Blood Institute, Contracts Operations Branch, 6701 Rockledge Drive, Room 6100, MSC 7902, Bethesda, MD 20892

Q -- LABORATORY TESTING SERVICE SOL NHLBI-PS-2000-625 DUE 072400 POC Deborah Coulter, Purchasing Agent, (301) 435-0368 Fax (301) 480-3345 The National Heart, Lung, and Blood Institute intends to negotiate on a non-competitive basis with the University of California, Simian Retrovirus Laboratory, to provide the laboratory testing as follows: (1) SRV:EIA, 1500 each; (2) SRV: WESTERN BLOT, 200 each; (3) SRV: PCR, 1500 each; (4) SIV: EIA, 40 each; (5) STLV-1: EIA, 40 each; (6) STLV-1 WESTERN BLOT, 40 each; and (7) STLV-1: PCR, 40 each. The University of California, Simian Retrovirus Laboratory (SRL) at the California Regional Primate Research Center, has been in operation since 1986, and has provided over 10,000 virological and serological analyses of nonhuman primate specimens annually. SRL has performed serological and genetic amplification testing for SRV in NIH nonhuman primates over the past several years. Continued testing by the same laboratory yields continuity in assessing laboratory results. SRL is an industry leader in the area of simian retroviral testing and is highly experienced in the use of PCR for SRV detection and the interpretation of indeterminate results is invaluable. SRL incorporates methodology and reagents that are validated, standardized and controlled by in-laboratory studies and quality control. Results are reviewed by personnel who are fully accredited by the American Society for Clinical Pathology and Laboratory Field Services of the State of California. In order to maintain continuity of the methodologies used the laboratory testing, an award to any other source for this acquisition would jeopardize the integrity of the primate models used in research protocols and would result in a substantial duplication of cost to the Government that is not expected to be recovered through competition. The Statement of Work is a follows: Background: The National Institutes of Health (NIH), Office of Research Service (ORS), Veterinary Resources Program (VRP), Primate Service Poolesville (PSP) provides the intramural program with the service and facilities to acquire and house nonhuman primates needed for research that is conducted at the NIH. The Primate Service Poolesville (PSP) is a service organization that provides the acquisition, quarantine and holding facility for almost all of the nonhuman primates used at the NIH. The service houses an average of 700 macaques (rhesus, pigtailed and cynomolgus moneys) and quarantines an average of 450 each year. During the quarantine period and periodically during standard holding, the viral status of macaques must be evaluated for the presence of Simian type-D Retrovirus (SRV). SRV is commonly found naturally in many wild and captive populations of macaques and can cause suppression of the animal's immune system, clinical disease and even death. Infection can severely complicate research efforts. With the high cost of using non-human primates in research, everything possible must be done to protect this valuable resource. This contract will facilitate the effective procurement of monkeys by providing SRV screening. Objective : Independently, and not as an agent of the Government, the Contractor shall furnish all necessary labor, materials, supplies, equipment, and facilities to perform the work set forth below. This requirement is for the furnishing of tests for SRV in macaques as follows: SRV screening by enzyme immunoassay (EIA/ELISA) confirmatory testing of positive and indeterminate EIA/ELISA by Western Blot; and genetic amplification detection by polymerase chain reaction (PCR). The period of performance is twelve (12) month period with options to renew for four (4) successive twelve (12) month periods. Contractor Tasks: Specifically, the contractor shall provide and deliver the following as requested by individual order: 1. Screening for SRV-1 and SRV-2 by enzyme immunoassay (EIA/ELISA), 2. Confirmatory testing of positive and indeterminate EIA for SRV-1 and SRV-2 by Western Blot. 3. Genetic amplification and detection by polymerase chain reaction (PCR) for SRV-1, SRV-2 and SRV-3. Methodologies -- Blood must be tested by methods that have shown acceptable sensitivity and specificity.Testing methodology must be acceptable by multiple NHP research facilities throughout the US. Methods and reagents must be validated and controlled by in-house quality assurance programs. Results must be reviewed by personnel who are accredited by the American Society for Clinical Pathology. SRV will be tested by EIA/ELISA and PCR; positive and indeterminate SRV ELISA/EIA tests will be confirmed by Western Blot. SRV EIA/ELISA must be able to detect serotypes 1 and 2. SRV PCR must be able to detect serotypes 1, 2 and 3. To evaluate macaques for SRV, blood must be tested for the presence of viral particles (which indicates the presence of the virus) and antibodies (which indicates exposure to the virus). Screening for antibodies against SRV should be by ELISA or EIA.. Since other viruses can cross react with the test, a Western Blot test must be done on positive or indeterminate EIA/ELISA results to confirm the presence of antibodies to SRV. Additionally, some animals may not produce antibodies after contracting the virus so blood must be evaluated for the presence of virus(genetic material). To do this a polymerase chain reaction (PCR) should be done. Reports and Deliverables: The contractor shall provide a complete copy of the individual test results by animal identification number, sample date and test(s) performed which consists of approximately 800 EIA, 120 Western Blot and 800 PCR. Reports will be sent by facsimile (301)480-0644 followed by US mail to PSP, Bldg 103, NIHAC, PO Box 56, Poolesville, MD, 20837. Review and Approval: The Government will ship the animal blood to the vendor's laboratory in the form (i.e. serum, plasma or whole blood with or without anticoagulant) designated by the vendor. Test results will be reviewed by the Chief, PSP (bldg 103, NIHAC) for approval and acceptance. Acceptance will be based on documentation of the completed tests as listed by test and animal number. Acceptance or rejection will be conveyed to the contractor by facsimile. The period of performance will consist of a basic contract period of (12) twelve months, with options to renew for (4) four additional (12) twelve month periods. This requirement is under the Standard Industrial Classification (SIC) Code 8733, Size Standard $5.0M. This acquisition is being conducted under simplified acquisition procedures and is exempt for the requirements of FAR Part 6. The solicitation number NHLBI-PS-2000-625, is issued as a Request For Quotation (RFQ). The solicitation document and incorporated provisions and conducted are those in effect through Federal Acquisition Circular 97-17. The following Federal Acquisition Regulation (FAR) clauses apply to this requirement; FAR Clause 52.212-1 Instructions To Offerors -- Commercial Items, FAR Clause 52.212-2, Evaluation- Commercial Items, FAR Clause 52.212-3, Offeror Representations And Certifications-Commercial Items, FAR Clause 52.212-4, Contract Terms and Conditions-Commercial Items, and FAR Clause 52.212-5, Contract Terms and Conditions Required to implement statutes or executive orders- Commercial items. The clauses are available in full text at http://www.arnet.gov/far/. This notice of intent is not a request for competitive proposals. Interested parties may identify their interest and capabilities in response to this requirement. The determination by the Government not to compete the proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining in whether to conduct future competitive procurement. Responses to this announcement, referencing synopsis number NHLBI-PS-2000-625, may be submitted to the National Heart, Lung and Blood Institute, Contracts Operations Branch, Procurement Section, Building RKL2, Room 6143, 6701 Rockledge Drive, Bethesda, MD 20892-7902, Attention Deborah Coulter, Purchasing Agent. All responsible sources may submit a proposal which if timely received, shall be considered by the agency. Posted 07/07/00 (W-SN472334). (0189)

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