2_JA 2269281.docx

Justification and Approval (J&A):

Brand-Name at or Below the Simplified Acquisition Threshold

Project Title: Luminex xMAP INTELLIFLEX DR-SE platform

Identification of the agency and contracting activity

I. Description of the project, and supplies or services required to meet the agency’s

a. Period of performance: 30 days ARO

A. Project Background: The mission of the Vaccine Research Center (VRC) is to translate basic scientific knowledge into vaccine products, antibody therapeutics or prophylactics against infectious pathogens for clinical use. To fulfill this mission, the VRC has established several laboratories, including the Virology Laboratory (VL). The goal of the VL at the VRC is to develop novel vaccine candidates against HIV-1, influenza, and other emerging infectious diseases, and to understand the cellular and molecular regulation of viral gene expression, entry into the cell, and correlates of immune protection, with the goal of developing safe and effective vaccines and antibody prophylatics and therapeutics. The Virology Core is a part of the Virology Laboratory and delivers services and expertise critical to the success of the research at the VRC. One approach toward achieving this goal is to design vaccine candidates including vectors and inserts that function as gene-based and protein-based immunogens to elicit cellular/humoral immune responses. The Virology Core provides investigators with DNA vectors, viral-based vectors including adenoviral vectors, lentiviral vectors, and alternative Ad vectors and recombinant proteins for basic research, vaccine applications, and crystallographic studies of vaccine candidates, preclinical studies, and clinical trials. The Virology Core also designs and examines the various vaccine delivery routes and vaccination platforms to enhance the immune responses. A major focus of the Virology Core is the generation of new platforms for vaccine development against infectious pathogens including HIV, influenza virus, chikungunya, Malaria, Middle East respiratory syndrome coronavirus, Ebola, etc. All these work require the detection of protein analytes from small-volume samples with high precision, sensitivity and throughput that can be done using a Luminex xMAP Intelliiflex DR SE system.

B. Description of the supplies/services to be purchased

· Multiplex Analyzer

· Brand Name: xMAP Intelliiflex DR-SE

· Manufacturer: Luminex

· Distributor: MilliporeSigma 400 Summit Drive Burlington, MA 01803

II. Identification of the statutory authority permitting other than full and open competition (SELECT ONE)

Important Note: The statutory authority listed below will rarely ever be used in NIH. Before selecting this authority, please ensure that you have read and understood the citation and discussed it with the cognizant Contracting Officer.

☐ 41 USC 3304(a)(5) and FAR Part 6.302-5: Authorized or required by statute / Brand Name

III. Demonstration that the proposed brand name product’s salient characteristics (specific features, qualities and/or the nature of the acquisition) requires use of the authority cited.

The Luminex xMAP INTELLIFLEX DR-SE platform is a highly advanced, multiplexed bead-based immunoassay system capable of simultaneously analyzing up to 500 analytes in a single sample. Its acquisition is critical to enhance the VRC’s capacity to evaluate vaccine and antibody candidates and human and animal serum sampleswith high precision, speed, and throughput. It enables the simultaneous detection and quantification of multiple analytes from a single and small-volume sample, with up to 10-fold less sample consumption compared to traditional ELISA-based assays, which is particularly beneficial for precious or limited human and animal serum samples for vaccine and antibody candidate evaluation. The Luminex xMAP INTELLIFLEX DR-SE offers dual reporter capabilities that improve sensitivity and allow broader dynamic range, ensuring robust detection of low- and high-abundance analytes in vaccine and immunology research. This system is versatile and compatible with a wide range of applications, including antibody titration, vaccine efficacy testing, and immunogenicity assessments. It also offers the flexibility to adapt assays for both research and preclinical/clinical trial needs. It consolidates numerous single-plex assays into one multiplex run, significantly reducing assay time, labor, and reagent costs, and importantly decreases turnaround time for critical vaccine development and antibody response data, supporting accelerated decision-making. The Luminex xMAP INTELLIFLEX DR-SE platform is designed with advanced data acquisition software that supports compliance with 21 CFR Part 11 requirements, ensuring data integrity for regulated studies. It also provides scalability to support increasing sample volumes and assay complexity without requiring additional instrumentation. The purchase of the Luminex xMAP INTELLIFLEX DR-SE will significantly expand the VRC’s capabilities in vaccine and antibody evaluation by providing multiplex, high-throughput analysis with exceptional sensitivity and reproducibility. This platform is essential for supporting current and future research objectives, particularly in immunology and infectious disease programs, while optimizing resource utilization and reducing operational costs.

The VRC has utilized Luminex xMAP instruments in the past decades and acquired a large pool of historic data for vaccine and antibody candidates. Unfortunately, the Luminex xMAP devices at the VRC are no longer supported by the manufacturer and can’t be periodically maintained. Though some other system such as MSD can offer similar capacity, but it has a much narrower detection range than the Luminex xMAP systems, thus requiring scientist to monitor appropriate dilution range to obtain valid measurements. This is not practical for precious and limited samples and can be time-consuming as well. Considering the need to compare with our historical data and the need to analyze large amounts of precious and limited samples, we propose to acquire the Luminex xMAP INTELLIFLEX DR-SE.