The U. S. Food & Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) is seeking to obtain "Onsite Services of a Visiting Scientist" for the Standardization and Performance of Zika Immuno-Detection Assays. FDA intends to generate Envelop Protein and NS-1 Proteins to use as reference materials for specific diagnostic tests to assess concentration and specificity in: Enzyme Linked Immunoabsorbant Spot (Elispot), Enzyme Linked Immunoabsorbant Assay (ELISA), Bead-Based Luminex Assays, Peptide Arrays and Flow Cytometry Methods. FDA will construct plasmids expressing EP to generate virus like particles to identify neutralization antibodies. Detection limits, specificity and reproducibility of the results will be assessed using sera from infected patients as well as mice models.

This effort involves the in vivo immunization of mice with antigens, subsequent sera and tissue collection. Additionally, Monkey Sera from Zika Immunized or infected animals may be used. Furthermore, Human Zika Immunized/Infected Sera may be used. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice.

This requirement is being solicited as a total small business set-aside (for small businesses only) using Simplified Acquisition Procedures per FAR Subpart 13.5. The associated NAICS Code is: 541380 - (Testing Laboratories) with a small business size standard of 500 employees. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. Please, see attached solicitation and respond as requested.

Bid Protests Not Available