2 - Brand Name Only.docx

Identification of the statutory authority permitting other than full and open competition Justification for other than Full and Open Competition: 41 USC 253(c) (1) and FAR Part 13.106-1(b): Brand Name Only

To maintain research continuity protocols, the requested brand name is required. The lab has used this assay panel in our current studies since the beginning, and due to our protocols, we must maintain consistency and continuity though out the entire study. As the threat of COVID-19 continues in the international community with new variants emerging every week, the need for a safe and efficacious monoclonal antibody therapy at an accelerated timeline is a health care priority. To assist in this effort, the VRC-VIP needs the electro chemiluminescent (ECL) assay format which they have recently developed for a SARS CoV-2 specific assay for the detection of specific antibodies directed towards SARS CoV-2 S-2P, SARS CoV-2 Receptor Binding Domain (RBD) and SARS CoV-2 N ( nucleocapsid proteins), SARS-CoV-2 NTD, SARS CoV-2 Sl, SARS CoV-2 S2, and variants (A.23.1, A.VOI.V2, C.37, R.1, P.3, B.1.525, B.1.1.519, BV-1, and B.617.2). Spikes that are 'printed' or 'spotted' in a single well of a MSD 96-well microtiter plate. 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. This platform has the needed high throughput for the simultaneous measurement of antibodies to their epitopes. The multi-plex assays used for Phase l and Phase 3 testing is on the MSD platform, and only the V-Plex kits manufactured from Meso Scale Discovery will work with the current platform utilized in the lab.