Microarray System with Analysis Package
Overview
Buyer
Place of Performance
NAICS
PSC
Set Aside
Original Source
Timeline
Qualification Details
Fit reasons
- NAICS alignment with historical contract wins in similar service areas.
- Scope strongly matches core technical capabilities and delivery model.
Risks
- Past performance thresholds may require one additional teaming partner.
- Potential clarification needed on staffing minimums before bid/no-bid.
Next steps
Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.
Quick Summary
The U.S. Food and Drug Administration (FDA), specifically the Center for Biologics Evaluation and Research (CBER), Division of Biological Standards and Quality Control (DBSQC), is soliciting quotes for a Microarray System with Analysis Package. This Combined Synopsis/Solicitation (RFQ) is critical for measuring the potency of neuraminidase components in influenza vaccines, supporting vaccine licensure and reference standard production. This opportunity is a Total Small Business Set-Aside. Proposals are due April 10, 2026.
Scope of Work
The required Microarray System with Analysis Package must:
- Be capable of using monoclonal antibodies to measure functional HA or NA in influenza virus subtypes.
- Allow simultaneous analysis of all HA or NA subtypes in multiplexed vaccine products.
- Measure content in inactivated egg-based, cell-based, and recombinant HA-based influenza vaccines.
- Provide results within one workday (less than 8 hours).
- Achieve assay sensitivity at or below 1 microgram/mL.
- Demonstrate lower sensitivity to environmental and matrix effects compared to enzymatic assays.
- Feature automated data analysis.
- Include racks and containers for slide storage and washing.
- Require specific Assay Kits: OmniFlu HA 96 (4 slides), VaxArray Influenza Seasonal NA Multivalent v2.0 (2 slides), Influenza A&B pAb Detection Label (10x) (2 slides), and Influenza NA A&B pAb Detection Label (10x) (2 slides).
- Operate with Windows 10 compatible software.
- Include a warranty of at least one year from instrument acceptance.
- Cover installation, onsite qualification (IQ/OQ), and training.
Contract & Timeline
- Contract Type: Firm-Fixed Price
- FOB Destination: U.S. Food and Drug Administration, CBER, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
- Set-Aside: Total Small Business (FAR 19.5)
- NAICS Code: 334516 - Analytical Laboratory Instrument Manufacturing
- Small Business Size Standard: 1,000 employees
- Submission Deadline: April 10, 2026, by 1:00 PM Central Time
- Published Date: March 31, 2026
Evaluation
Proposals will be evaluated based on Technical Acceptability and Price. The lowest priced offer will be evaluated first. If it is not technically acceptable, the next lowest priced offer will be considered. Technical acceptability will be determined by sufficient descriptive material demonstrating the proposed system meets all requirements.
Additional Notes
- Offerors must be registered and active in SAM.gov by the submission deadline.
- Any catalog number, manufacturer brand name, or proprietary description is used for descriptive purposes only and is not restrictive.
- Offerors must comply with Section 508 accessibility standards for Information and Communication Technology (ICT).
- Electronic documents must not contain macros.
- Submit proposals via e-mail to howard.nesmith@fda.hhs.gov.