BioRad QX200 Droplet Digital PCR System

Statement of Work (SOW) / Performance Work Statement (PWS)

The government requires the purchase of one (1) BioRad QX200 droplet digital PCR system to support DNA and RNA analyses for microbial contaminant identification, detection, quality control, and quantification for genomic microbiology research. This system will replace an aging, heavily used instrument critical to established laboratory workflows and ongoing research.

• Supply Requirement: One (1) Bio-Rad QX200 Droplet Digital PCR system.

• System Configuration: Must be compatible with existing QX200 instrumentation, consumables, and validated laboratory workflows. Includes manual droplet generator, droplet reader, computer, software, one-year warranty, and associated consumables for EvaGreen or probe-based systems.

• Services: Includes delivery, installation, training, and initial operational verification.

• Maintenance Requirement: One (1) year service plan following the manufacturer's warranty, including preventive and corrective maintenance, OEM replacement parts, software/firmware updates, and qualified personnel.

• Functional Capabilities: Perform droplet generation, quantitative analysis of DNA/RNA, generate concentration measurements, and provide results in formats suitable for downstream applications (NGS, whole genome microarray, qPCR).

• Performance Characteristics: Process up to 96 samples per run (2-3 hours), require no more than 5 µL sample input, and provide reproducible results.

• Software: Automated data acquisition and analysis, tabular and graphical outputs, concentration calculation, droplet size exclusion, and data export compatible with existing lab systems.

• Service Response: Acknowledge service requests within 24-48 hours; on-site corrective maintenance within two business days.

• Base Period (Equipment + Warranty): July 1, 2026 - June 30, 2027.

• Option Year (Service Plan): July 1, 2027 - June 30, 2028 (if funded).

• Place of Performance: FDA, 8301 Muirkirk Road, Laurel, MD 20708.

• Compatibility: Must be fully compatible with existing QX200 instrumentation, proprietary consumables, validated SOPs, quality control thresholds, and data workflows to maintain data integrity.

• Delivery: Within 30 days after award to the specified FDA location during business hours.

• Security: Contractor personnel require advance notification for facility access, must comply with FDA access requirements (sign-in, badging, escort policies), and remain under escort.

Form / Attachment / Pricing Sheet

This document is a Brand Name Justification for the replacement of an aging Bio-Rad QX200 Droplet Digital PCR (ddPCR) system. It explains the necessity of acquiring this specific system due to ongoing research requirements and the need for methodological continuity and data comparability.

• Description of the Requirement: The Office of Applied Microbiology and Technology (OAMT) needs to replace an aging Bio-Rad QX200 ddPCR system for research on hepatitis A virus (HAV) detection in food matrices. The estimated value is approximately $38,000.
• Brand Name Specification: The requirement is specifically for the Bio-Rad QX200 Droplet Digital PCR System, including compatible components. This brand-name restriction is justified under FAR 11.105.
• Minimum Technical Requirements: The system must utilize droplet-based partitioning, be fully compatible with Bio-Rad QX200 workflows and QX Manager Software v2.2, produce comparable data to existing validated datasets, support continuity of validated methods for HAV detection, and be interoperable with external collaborators.
• Rationale for Brand Name Restriction: The justification highlights that current research and method development are optimized for the QX200 platform, and existing datasets are tied to its output formats. Using an alternative platform would require significant revalidation, leading to delays and disruption. The system is needed to maintain operational capability and ensure research continuity.
• Unique Capabilities of the Bio-Rad QX200: Specific capabilities include established method validation baseline, droplet generation consistency, software compatibility with existing templates, data continuity from historical datasets, and inter-laboratory standardization.
• Market Research Summary: Several alternative digital PCR systems were evaluated but found insufficient due to different partitioning technologies, incompatible data output formats, different software environments, and the need for extensive revalidation. The QX200 system is proprietary to Bio-Rad, but authorized distributors may provide it.

This document indicates a brand-name requirement for a specific piece of equipment (Bio-Rad QX200 ddPCR System). Bidders interested in fulfilling this requirement must be able to provide this exact system or be an authorized distributor. The justification outlines the technical reasons for this restriction, emphasizing continuity, comparability, and the avoidance of research disruption.