This Combined Synopsis/Solicitation opportunity was posted on April 10, 2017. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

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Standardization and Performance of Zika Immuno-Detection Assays

Closed

FDA-RFQ-2017-1176966Federal

Submission Closed04/21/2017, 05:00:00 PM UTC

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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NAICS: 541380

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AI Contract Overview

The U.S. Food and Drug Administration's Center for Devices and Radiological Health is seeking a visiting scientist to provide onsite services for the standardization and performance of Zika immuno-detection assays in Silver Spring, Maryland. The project focuses on generating Envelop and NS-1 proteins to serve as reference materials for various diagnostic tests, including ELISA, Elispot, and Flow Cytometry. The scope of work includes constructing plasmids to create virus-like particles and assessing detection limits and reproducibility using sera from human patients, mice models, and monkeys. This opportunity is solicited as a total small business set-aside under NAICS code 541380 for testing laboratories. The procurement follows Simplified Acquisition Procedures, and the combined synopsis and solicitation serves as the sole request for quotes. Interested small businesses were required to respond by April 21, 2017, as no further written solicitation will be issued.

General Info

FDA seeks small business visiting scientist for Zika immuno-detection assay standardization in Maryland.

Agency

N/A

NAICS

541380 - Testing Laboratories and Services

Place of Performance

FDA Laboratory of Infection Control, Division of Biology, Chemistry and Material Sciences Office of Science and Engineering Lab, SILVER SPRING, MD, 20993, USA

Set-Aside

SBA

Documents

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Timeline

PhaseClosed

PostedApr 10

Combined Synopsis

Response DeadlineApr 21

Deadline has passed

Submission Closed

04/21/2017, 05:00:00 PM UTC

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Organization & Contact Information

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Full Description

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.