Meso scale multi-array plate packs and u-plex development packs

This is a Notice of Intent, not a request for proposal.  The National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) intends to negotiate an other than full and open competition basis with MESO SCALE DIAGNOSTICS, 1601 RESEARCH BOULEVARD, ROCKVILLE, MD 20850, United States, to procure MULTI-ARRAY PLATE PACKS AND U-PLEX DEVELOPMENT PACKS.

The Vaccine Immunology Program (VIP) aids the Vaccine Research Center (VRC) by supporting the development of monoclonal antibodies and vaccines for infectious diseases such as HIV, Influenza, Ebola and more recently SARS-CoV-2 Coronavirus. Support is through the state-of-the-art laboratory performing Phase 1 and Phase 3 clinical end point testing to inform further study designs, research questions and vaccine modification and design. As part of a broader strategy to accelerate the development of monoclonal antibodies as therapy, VIP has identified the electrochemiluminescent (ECL) assay format as the most reliable and sensitive assay system that offers high dynamic range in the detection of antibodies isolated. Specifically, the VIP is developing assays and new pipelines for detection of binding antibodies to respiratory virus spike or glycoproteins, which offers high throughput measurement of immune responses elicited by infections and vaccinations.

Requirements List:

-MULTI-ARRAY® 96 Plate Pack (100 Plate), CAT. #L15XA 6 – QTY-2

-U-PLEX Development Pack, 10-Assay SECTOR Plate (25 Pl), CAT. #K15235N-4- Qty-1

-Shipping and Handling

Sole Source Justification:

As the threat of respiratory diseases continues in the international community, the need for a safe and efficacious vaccines and monoclonal antibody therapies is a health care priority. To assist in this effort, the VRC-VIP will use the electrochemiluminescent (ECL) assay format, which VIP with MSD has recently developed for assays for the detection of specific antibodies directed towards SARS CoV-2 S2P and other respiratory disease glycoproteins. The VRC-VIP identified the ECL assay as the most reliable and sensitive assay system over the last 10 years, that offers high dynamic range in the detection of specific serum antibodies generate towards a variety of viral proteins. The platform offers extremely high throughput for the simultaneous measurement of antibodies to their epitopes. The MSD are the sole owners of the intellectual property of the ECL reader technology, Meso Sector S 600MM, that is government owned and operated and provides the associated assays and plates designed to be used on the MSD reader. The MSD technology has been identified as the only suitable option by the VIP for endpoint testing for clinical trials, correlate of protection testing, and screening of therapeutic mAbs.

Period of Performance: 90 DAYS ARO

The statutory authority for this sole source requirement is 41 U.S.C. 253 (c) (1) as implemented by FAR 13.106-1 only one responsible source and no other supply of service will satisfy agency requirements. THIS IS NOT A REQUEST FOR PROPOSAL.  All responsible sources that could provide comparable services may submit a capability statement that will be considered by email (subject line to reference NOI-NIAID-24-2220901) to Angela Puddy at angela.puddy@nih.gov by 1:00 pm EASTERN Standard Time, Tuesday, May 28, 2024.  Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f). All responses received by the closing date of this synopsis will be considered by the Government. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government.