Office of Biomedical Advanced Research and Development Authority Broad Agency Announcement (BAA)

Closed Special Notice Posted

This opportunity was awarded. See its 17 award notices in the notice history.

Agency
Responses due
Set-aside
No set-aside

Opportunity facts

Place of performance
Rockville, Maryland, United States

Notice details come from SAM.gov. Updated .

About this opportunity

This Special Notice from the Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response seeks proposals for the development of multiplexed SARS-CoV-2 antigen panel assay kits. The antigen panel assay kits will measure total antibodies that block binding of angiotensin-converting enzyme 2 to the receptor binding domain of SARS-CoV-2 as well as antibodies that bind to the whole Spike, receptor binding domain, and nucleocapsid antigens of SARS-CoV-2.

The overall objective is to develop multiplexed SARS-CoV-2 antigen panel assay kits for quantifying human antibodies in serum and mucosal samples. Contractors must demonstrate the capability to develop and manufacture the antigen panel assay kits to the specifications provided by the agency. The antigen panel assay kits must be capable of measuring specified antibodies to SARS-CoV-2 variants and include appropriate standards and controls. The due date for responses was September 29, 2023. Contractors must function as antigen panel assay kit developers and ISO 9001 manufacturers to support advanced research, development, and evaluation of COVID-19 vaccines. Data from the antigen panels may support immunogenicity analyses for vaccine clinical studies and efficacy monitoring.

Notice text

The overall objective of this contract is to develop multiplexed SARS-CoV-2 antigen panel assay kits for human antibody (e.g., IgA and IgG when appropriate) quantification by electrochemiluminescence in serum and mucosal samples. The antigen panel assay kits shall be capable of measuring total antibodies that block binding of angiotensin-converting enzyme 2 (ACE2) to the receptor binding domain (RBD) of the SARS-CoV-2 ancestor and selected variants printed in custom configurations. The antigen panels shall be capable of measuring Ig, IgG and IgA antibodies that bind to the whole Spike (S), receptor binding domain (RBD) and nucleocapsid (N) antigens of the SARS-CoV-2 ancestor and selected variants printed in custom configurations. The antigen panel assay kits shall include appropriate standards and controls to support development and validation of the assays described
above at USG-designated laboratories.
The scope of work includes providing multiplexed SARS-CoV-2 antigen panels assay kits for human antibody (e.g., IgA and IgG as appropriate), to be used in either direct SARS-CoV-2 antigen-binding or ACE2 receptor-blocking, quantification by electrochemiluminescence. The Contractor will function as a USG antigen panel assay kit development and ISO 9001 manufacturer to support advanced research and development and evaluation of COVID-19 vaccines. Data from these panels may be used in primary, secondary, and exploratory immunogenicity endpoint analyses for vaccine clinical studies as
well as monitoring their subsequent efficacy.

Notice history

6 notices listed here. See the rest on GovTribe.

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