MALDI-TOF Biotyper Sirius

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.