PCR based Proximity Extension Assay

Active

Contract Opportunity

Sources Sought (SS) Notice

Title: PCR based Proximity Extension Assay

ID: NIAID-SS-25-2265399

Post Date: 07/18/2025

Response Date: 08/04/2025

Classification Code: 6640 – Laboratory Equipment and Supplies

NAICS: 334516 Analytical Laboratory Instrument Manufacturing

Introduction

This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential requirement.

Project Summary

The Viral Pathogenesis and Evolution Section (VPES) and The Clinical Studies Unit (CSU) within Laboratory of Infectious Diseases (LID) conducts research directed toward defining the causes and epidemiology of influenza and SARS-CoV-2 viral disease and developing means for their control, including universal influenza and SARS-CoV-2 vaccine development. VPES and CSU engages in a wide range of research activities that extends from clinical virology to molecular characterization of highly virulent influenza and SARS-CoV-2 viruses that cause severe, acute disease of the respiratory tracts in animal models to the development of novel vaccines and antiviral drugs. We also study immune responses and disease following human influenza viral challenge at the NIH Clinical Center. Scientists in the VPES employ high-throughput genomic, proteomic and machine learning computational approaches to elucidate pathogenesis of influenza disease, understand the response to infection, contagiousness, development of severe illness, as well as identify the molecular correlates of vaccine protection in animals and humans.

The purpose of this request is the purchase of a PCR based Proximity Extension Assay for qPCR readout. This Proximity Extension Assay (PEA) will be used to measure individual inflammatory cytokine and chemokine proteins in nasal, PBMC, and serum samples from animal and human model influenza challenge studies. As part of the H5N1 project, the PCR based Proximity Extension Assay system will be used to assess immune responses to various therapeutics in influenza virus-challenged mice, as part of the VPES and CSU mission to develop novel antiviral and therapeutic measures to combat the ongoing avian influenza pandemic in poultry and wild birds.

Specifically, NIAID, is seeking one PCR based Proximity Extension Assay system capable of the following:

The system must be a benchtop instrument for multiplexing protein measurements, with a software and analysis platform designed to analyze specific biological processes with multiplex immunoassay panels.

The minimal salient characteristics for the system are as follows:

• Size: The system must have a small footprint of 21.6in height x 10.6in width x 23.6 in depth, allowing for benchtop or BSC use.

• Capability: The system must be able to analyze just 1uL of sample to allow for more versatile use and preservation of limited sample supply, as it will be used in analyzing data for clinical studies where samples are limited and experiment replication is necessary for accuracy. The system shall offer high specificity and sensitivity by combining antibody-based detection with PCR amplification (high plex and not prone to cross-reactivity like bead-based technologies). The system shall be validated using EDTA plasma and serum samples and be compatible with over 20 unique sample types such as citrate plasma, heparin plasma, tissue and cell lysates, CSF, saliva.

• Streamlined Workflow: The system workflow shall limit break points in the assay such as washing steps and hands-on instrument handling.

• Kit Integration: The system must have a minimum of 15 uniquely designed panels built for specific disease areas and biological processes, each providing simultaneous analysis of 92 specific protein biomarkers. These panels must be thoroughly validated in more than 1100 peer-reviewed publications. The panels shall address specific disease areas of key biological processes (immunology, biological processes, inflammation, and metabolism) with multiplex immunoassay panels.

• Normalization and Controls: The system must provide quality control measures via software integration for in-built normalization via calibration, internal controls, and external controls.

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  • In-built data normalization via relative units allows for tracking of relative changes in analytes of interest and reduces technical variation and plate-to-plate variations.
  
  
  • The system shall provide four internal controls to monitor individual sample performance and identify outliers without the need for replicate samples. The controls shall monitor all three steps of the extension assay protocol; immuno reaction / incubation (control for technical variation), extension (control for signal variation independent of the immune reaction), and amplification / detection (to assure successful detection).
  
  
  • The system shall provide three types of external controls, each in replicate. There shall be an inter-plate control (to normalize each assay and compensate for potential variation between runs and plates), a negative control (to set the background levels through noise adjustment and calculate the Limit of Detection), and a sample control (to assess potential variation between runs and plates, conduct troubleshooting, and assess inter-assay and intra-assay CV) and integrated controls monitor every step of the workflow for each sample.
  
  
  
  

• Maintenance and Training: Training and regular maintenance shall come standard with instrumentation, and instruments shall self-calibrate with no daily/weekly/monthly maintenance. Plug and play installation shall require no service engineers.

• Continuity: The laboratory section currently uses instrumentation from Olink. The System must be seamlessly compatible with the current connections, capabilities, the 10x Genomics kits, and Olink Target 96 technologies to ensure the continuity of the ongoing research studies.

Anticipated Period of Performance

It is anticipated that an award will be made on or about August 29, 2025. Estimated lead time for delivery of Equipment is 45-90 days upon Vendor’s receipt of the purchase order.

Capability Statement/Information Sought

If your organization has the potential capacity to meet the minimum requirements and performance capabilities listed above, please provide the following information:

1. Organization name, address, point of contact, email address, website address, telephone number, UEI number.


2. Company location(s) and number of years company has been in business.


3. Type of business (e.g., 8(a), HUBZone, Other than Small, etc.) pursuant to the applicable NAICS code.


4. Type of ownership for the organization.


5. Identification of any Best-In-Class contract vehicles including Government Wide Acquisition Contracts (GWAC) (e.g., GSA schedule) they may possess or are aware of that would support this possible requirement. If your organization does not provide the products/services under a GWAC, please identify availability as OPEN MARKET ONLY.


6. Tailored capability statement addressing the capability of the sequencing instrument to meet NIAID’s minimum requirements. Capability document shall be no more than six pages.


7. Place of manufacture for the PCR based Proximity Extension Assay.


8. Evidence that the organization is an authorized reseller or manufacturer of the instrument. Only Original Equipment Manufacturer (OEM) products are acceptable.

Submission Instructions

Interested businesses who consider themselves qualified to provide the above specification for the PCR based Proximity Extension Assay, are invited to submit a response to this Sources Sought Notice by August 4, 2025, at 1:00 PM EST. All responses under this Sources Sought Notice shall be emailed to Shaun Rostad at shaun.rostad@nih.gov

Disclaimer and Important Notes

This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published on SAM.gov. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality

No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

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