Intent to Sole Source - Medical/Scientific Instruments for the Department of Transfusion Medicine, NIH Clinical Center

s and other transfusion-transmitted pathogens. The required system must support generation of high-quality quantification data from clinical specimens, including viral RNA/DNA and host-derived nucleic acids. The instrument must enable applications such as targeted genome amplification, work with a wider dynamic detection range, support the library prep for viral genome sequencing, and assay development workflows necessary for evaluating test performance and refining diagnostic methods prior to implementation in a clinical testing environment. The system must meet the following functional and operational requirements: High data accuracy and reproducibility to ensure reliable detection of viral variants and evaluation of assay performance; Low- to moderate-throughput capability appropriate for assay development, pilot studies, and validation activities involving smaller sample sets; Rapid turnaround times to support iterative testing and optimization of clinical assays; Flexible run configurations that allow efficient processing of varying sample volumes without excess capacity; Cost-efficient operation, including the ability to minimize per-run and per-sample costs for pathogen detection; Integrated and streamlined workflows, including nucleic acid extraction, amplification, quantification and data analysis within a platform from the same vendor to reduce complexity and variability; Ease of use and standardized operation, supporting reproducibility and implementation in a clinical laboratory environment; Compatibility with established nucleic acid preparation and amplification methods and existing laboratory workflows. The flexibility to be using the systems in a CLIA certified environment. The statutory authority for this sole source requirement is 41 U.S.C. 253(c) (1) as implemented by FAR 6.302-1 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 the required may submit a capability statement that will be considered by email (subject line to reference NOI-OLAO-CC-27-000121) by 12:00 PM eastern standard time on 10/23/2026 to: valerie.gregorio@nih.gov. 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.