Attachment 1 - SOW.pdf

Statement of Work

1. Background

The select agent laboratory at Moffett participates in the Laboratory Response Network (LRN) for detecting botulinum neurotoxins (BoNTs). Traditional mouse bioassays, though the gold standard, are costly, slow, and raise ethical concerns. Previously, DIG-ELISA kits were used for high-throughput screening to reduce animal use, but these kits are being phased out in favor of the Endopep-MS (Endopeptidase–Mass Spectrometry) assay.

Developed over 10 years by CDC’s Biological Mass Spectrometry Laboratory, the Endopep-MS assay detects BoNT activity on peptide substrates that mimic the toxin’s natural targets. This method eliminates animal testing and allows high-throughput analysis, supporting rapid response in large-scale events.

The FDA requires one (1) Bruker MALDI-TOF Biotyper Sirius one GP system to replace an obsolete instrument. The system must support Endopep-MS assays for detection, differentiation, and characterization of Clostridium botulinum neurotoxins, maintaining operational capability critical to mission readiness and public health protection.

2. Objective

Acquire, install, and validate one (1) FDA-approved benchtop MALDI-TOF mass spectrometer with associated software, workstation, peripherals, training, and warranty to ensure uninterrupted capability for neurotoxin detection and microbial identification.

3. Scope of Work

The Contractor shall provide:

• One (1) Bruker MALDI-TOF Biotyper Sirius one GP system

• Required software and reference libraries

• Dedicated computer workstation meeting specifications

• Associated peripherals and accessories

• On-site installation and operational qualification

• Two (2) days of on-site application training

• Warranty and technical support

• Freight and delivery

All components shall be new, current production models, and fully supported by the manufacturer.

4. Required Equipment and Deliverables

Item No. Description Quantity Unit

1 MALDI-TOF Biotyper Sirius one GP 1 Each

2 On-site Application Training (2 Days) 1 Each

3 MBT Compass HT Industry Software Package 1 Each

4 UPS Powervar ABCE602-11 120VAC 1 Each

5 Bruker Standard Laser Printer, 115V Color 1 Each

6 Freight (Intercontinental, if applicable) 1 Lot

5. Technical Requirements

Instrument Requirements:

• FDA-approved benchtop MALDI-TOF mass spectrometer

• Small footprint for standard benchtop installation

• 60 Hz N₂ cartridge laser with variable power attenuator and UV optics

• Supports Endopep-MS assay for C. botulinum neurotoxin detection

• Microorganism identification and classification using MALDI-TOF MS profiles

• Automated processing from raw spectra to peak lists and reference spectra

• Validated, current microorganism reference library

Computer Workstation:

• 2.66 GHz single CPU quad-core processor (or current equivalent)

• Minimum 12 GB RAM

• Minimum 2 TB hard drive

• DVD +/- RW drive

• At least one Ethernet port

• LCD monitor

• Pre-installed, fully licensed OS compatible with instrument software

Software Requirements:

• MS data acquisition and processing

• Automated data analysis

• Microorganism identification and classification

• Reference library access

• Audit trail capability

• Compliance with FDA IT and security policies

6. Delivery and Place of Performance

Delivery Location:

FDA Moffett Laboratory 6502 S. Archer Rd., Bedford Park, IL 60501

Delivery Timeline: Within 60 days of contract award

Shipping:

• Equipment shall be securely packaged

• Contractor shall coordinate delivery with laboratory point of contact

• Freight included in total price

7. Installation and Acceptance

Installation:

• On-site setup and configuration

• Electrical compatibility verification

• UPS integration

• Software and reference library installation

Operational Qualification:

• System calibration and performance verification

• Demonstration of proper operation

• Documentation of installation and operational verification

Acceptance Criteria:

• All components delivered and installed

• Instrument meets manufacturer’s specifications

• Software operates as specified

• Endopep-MS assay capability demonstrated

• Training completed

• Documentation received

8. Training

• Two (2) consecutive days of on-site training

• Instruction on instrument operation, routine maintenance, data acquisition and analysis, and troubleshooting

• Training materials and user documentation provided

9. Warranty and Support

• Minimum one (1) year full warranty from acceptance, including parts, labor, and travel

• Technical support via phone and email, with 48-hour response time

• Software updates included during warranty

• Optional extended warranty pricing may be provided separately

10. Quality Assurance

• System meets manufacturer specifications

• New and free of defects

• Documentation certifying regulatory compliance included

• Government may inspect and test upon delivery

11. Security Requirements

If connected to FDA networks:

• Must comply with FDA IT security policies

• Support secure user authentication and maintain audit logs

• Contractor personnel must coordinate access with laboratory management

12. Compliance

Contractor shall comply with all applicable:

• FDA laboratory safety requirements

• Electrical and environmental standards

• Federal, state, and local regulations