HIV-SELECTEST EIA Kits

On behalf of the National Heart, Lung, and Blood Institute, Westat, under the Retrovirus Epidemiology Donor Study (REDS) Program, will be seeking proposals from all interested infectious disease test developers/manufacturers for refining, assembling, validating and obtaining FDA approval for HIV-SELECTEST EIA kits for distribution to national and international laboratories conducting blood donor screening in developing countries where HIV vaccination is likely to become prevalent. These kits will be used for distinguishing true HIV-1 infections from vaccine-induced HIV-1 antibody responses in blood donors. Additional proposal requirements include plans for developing, refining, assembling, validating and FDA licensing a Rapid HIV-1 Antibody Test based on the HIV-SELECTEST, which is presently being developed by FDA as a second generation HIV-SELECTEST. For both tasks, work will be conducted in two stages to include preclinical studies/test refinement, and clinical trials/test validation. For the development and subsequent manufacture of the HIV-SELECTEST EIA kits contractors will be responsible for preparing, purifying and testing the HIV-1 synthetic peptides to be used in the HIV-SELECTEST. There are four peptide sequences, two for Gag p6 and two for gp41 EIA. Verification of the specificity, sensitivity, and reproducibility of the EIA must be conducted using commercially available serological reference panels, clinical specimens from HIV-1 vaccine trials, specimens from studies deemed as false positives or indeterminate based on FDA-licensed serological kits and Western Blot kits, specimens from HIV-1 epidemiological evaluations, and other studies with infectious agents relevant to HIV-1 infection. Pre-clinical sensitivity and specificity study requirements for an IND will be provided. Comparison and stability studies to define the sensitivity, specificity, reproducibility, and robustness of the HIV-SELECTEST EIA in detecting acute HIV-1 infections will be required. For clinical trials/test validation, the contractor will be expected to ship and distribute kits to up to 20 national and international infectious disease screening laboratories supporting HIV-1 vaccine trials, which will conduct clinical testing of specimens obtained from Phase I-III clinical trials. In conjunction with this, in-house parallel testing of 10-15% of these specimens being tested by infectious disease screening laboratories is required for QA/QC compliance and assessment of results variability across laboratories, variability across kit lots, and kit stability. Finally, the contractor shall submit a Biologics License Application (BLA) to the FDA. Plans for the Rapid HIV-1 Antibody Test should include refinement of the assay. Given that this assay is presently being developed by FDA scientists as a second generation HIV-SELECTEST, the technology will be transferred to the contractor following the award. Contractors will be required to compare the performances of the HIV-SELECTEST EIA, the Rapid HIV-1 Antibody Test, and current FDA approved HIV-1 tests. These comparison studies will test clinical specimens in parallel with participating regional and national testing laboratories that perform screening and confirmatory testing for blood donors that also contain specimens derived from centers supporting HIV-1 vaccine clinical trials. To conduct the comparative studies the contractor will develop an External Quality Assurance program containing Standard Proficiency Testing Panels. Upon completion of the testing the contractor will prepare and submit to the FDA a Premarket Approval (PMA) application. This acquisition has been designated as full and open competition. It is anticipated that one award will be made for a period of 3 years. THIS PRESOLICITATION NOTICE IS NOT THE REQUEST FOR PROPOSALS (RFP); the Request For Proposals must be downloaded from the Westat Web Site, and will be available on or about October 10, 2008 at the following internet address: www.westat.com. The estimated due date for proposals is December 15, 2008. Point of Contact Russell Walker, Sr. Contract Administrator - Phone (240) 453-5624; Fax (301) 738-3500; Email russellwalker@westat.com.