SAM #NOI-OLAO-CC-27-000121

NIH Clinical Center intent to sole-source laboratory instruments for pathogen research

NIH Clinical Center plans a sole-source acquisition of three laboratory instruments for research on transfusion-transmitted pathogens. - Agency and procurement approach - The National Institutes of Health (NIH), Clinical Center (NIH-CC), Department of Transfusion Medicine (DTM), Infectious Diseases Section, intends to acquire the instruments from Fisher Scientific. - This is a notice of intent under other-than-full-and-open competition, not a request for proposals. NIH invites capability statements from responsible sources. - Instruments sought - One real-time PCR system, one automated nucleic acid extractor, and one microvolume spectrophotometer; specific models, part numbers, and quantities are not provided. - The notice names Fisher Scientific as the intended vendor; attachment filenames also reference Thermo Fisher. - Purpose and requirements - Support development, optimization, and validation of diagnostic assays for hepatitis viruses and other transfusion-transmitted pathogens. - Provide accurate, reproducible analysis of viral and host nucleic acids with low-to-moderate throughput, rapid turnaround, flexible run configurations, and cost-efficient operation. - Support an integrated workflow for extraction, amplification, quantification, and data analysis, while remaining easy to use, compatible with existing laboratory methods, and suitable for a CLIA-certified environment.

Description

This is a Notice of Intent, not a request for proposal.  The National Institute of Health, Clinical Center (NIH-CC) intends to negotiate on an other than full and open competition basis with the following vendor: Fisher Scientific.

Acquisition Description:

The NIH Clinical Center, Department of Transfusion Medicine (DTM), Infectious Diseases Section requires acquisition of a 1) Real-Time PCR System, 2) an Automated Nucleic Acid Extractor and 3) a microvolume spectrophotometer to support clinical research and the development, optimization, and validation of diagnostic assays for hepatitis viruses 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.

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