SAM #75F40126R00030

FDA Procurement of Bruker MALDI-TOF Biotyper Sirius System for Neurotoxin Detection

The Food and Drug Administration (FDA) is seeking to procure a Bruker MALDI-TOF Biotyper Sirius one GP system for its Moffett Laboratory to support Endopep-MS assays for the detection and characterization of Clostridium botulinum neurotoxins. - Government Buyer: - Food and Drug Administration (FDA), Moffett Laboratory - Office of Acquisition and Grant Services (contracting office) - OEM Highlight: - Bruker is the specified Original Equipment Manufacturer (OEM) for all major system components - Products and Quantities: - Bruker MALDI-TOF Biotyper Sirius one GP system (Qty: 1; Part Number: 1890221) - MBT Compass HT Industry Software Package (Qty: 1; Part Number: 1868405) - UPS Powervar ABCE602-11 120VAC (Qty: 1; Part Numbers: ABCE602-11, 8605553) - Bruker Standard Laser Printer, 115V Color (Qty: 1; Part Number: 1902007) - Freight/Shipping and Tariff/Customs Surcharge (Qty: 1 each) - Services Requested: - On-site installation and operational qualification (Qty: 1) - Two days of on-site application training (Qty: 1; Part Number: DAL00909) - Notable Requirements: - System must be FDA-approved and delivered within 60 days of contract award - Includes warranty (minimum one year), parts, labor, travel, and software updates - Must comply with FDA IT security policies and operational qualification standards - Instrument replaces an obsolete system and is critical for high-throughput analysis, eliminating the need for animal testing - Place of Performance/Delivery: - FDA Moffett Laboratory, 6502 S. Archer Rd., Bedford Park, IL 60501 - Contracting Office: - FDA Office of Acquisition and Grant Services, 11601 Landsdown St, Floor 13, Rockville, MD 20852

Description

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.

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