MALDI Biotyper Sirius CA

Background
The Puget Sound VA Medical Center, located in Seattle, WA, is seeking a contractor to provide a MALDI (Matrix-Assisted Laser Desorption Ionization) Mass Spectrometry (Microbial Identification System). The goal of the contract is to acquire an FDA-approved automated testing system that identifies microorganisms using Matrix Assisted Laser Desorption Ionization Mass. This system must meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI).

Work Details
The contractor shall provide the following products:
- MALDI Biotyper Sirius CA System
- MBT Compass HT
- MBT HT Filamentous Fungi Module
- MBT Filamentous Fungi Library Extension
- MBT HT Sepsityper Module
- MBT Sepsityper Kit US IVD.

Key features include:
- Identification of microorganisms using MALDI-TOF mass spectrometry with a reference library of at least 488 microbial species.
- Rapid identification from positive blood cultures within 15-20 minutes.
- Compatibility with non-clinically validated libraries for research use.
- Modules for Filamentous Fungi and Mycobacteria, with machine-learning capabilities for database expansion.
- Benchtop solution weighing 75kg or less, operating on standard 110V power outlets, with low power consumption (max 400 Watts).
- Quiet operation (<50 db) and fast analysis capabilities (up to 600 samples per hour).

Place of Performance
Puget Sound VAMC, 1660 S Columbian Way, Seattle, WA 98108

Incumbent Analysis (see Incumbents section for more detail)
This opportunity appears to have a confirmed incumbent and/or closely related prior contract based on Beckman Coulter’s prior MALDI Biotyper award(s) for VA microbiology laboratory support. The prior work included provision, installation, and software for a MALDI Biotyper Sirius One CA system along with interfacing LabPro MBT software and supplying service plans and consumables (including Sepsityper kits), which aligns closely with the current requirement for an FDA-approved MALDI Biotyper Sirius CA microbial identification system with associated modules and libraries. The overlap in system family (Sirius CA/CA variants), microbiology identification use case, and inclusion of software/interface plus Sepsityper-related consumables suggests continuity of the same type of capability at a VA medical center.