MALDI TOF Sole Source Letter 2-21.pdf
PDF 223 KB Posted
- Attached to
- Bruker Maldi-Tof Purchase - SS
- Solicitation number
- 22-482DPH-HLTHP-B-27583
- Issued by
- St. Clair County, Illinois
About this file
This document is a sole source justification for the purchase of 3 MALDI TOF instruments from Bruker Scientific, LLC for the state of Illinois. The Bruker MALDI-Biotyper System is a vertically integrated microorganism identification system that includes a MALDI TOF mass spectrometer, reference library, service support, and training. The system features an open platform for integration into clinical and veterinary workflows, direct analysis of positive blood cultures, and CDC-Microbenet capabilities. It has FDA clearance for the identification of 333 microorganisms across 424 species with an overall accuracy of 99.78% to the genus level and 98.19% to the species/complex level.
The state of Illinois intends to award a contract to Bruker Scientific, LLC as the sole source provider of this system. An interested party has the opportunity to submit written comments or request a public hearing by March 25, 2022 to contest the sole source award. No other pricing, set aside, or funding details are provided in this document.
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SOLE SOURCE
Bruker Daltonics Inc
Bruker MALDI-Biotyper System 40 Manning Road
For Microbiology Manning Park
Microorganism Identification Billerica, MA 01821 +1 (978) 663-3660 www.bdal.com
Bruker Daltonics Inc. is the Manufacturer and Sole Source of the MALD-Biotyper Microorganism Identification System
Unique Features of Bruker’s MALDI-Biotyper Microorganism Identification System
• Vertically integrated single-source provider for system components including MALDI TOF mass spectrometer, microorganism reference library, ongoing service support, and applications training and support.
• Open platform for integration into clinical/ veterinary microbiology laboratory workflows where multiple systems are used for antibiotic susceptibility testing, blood culture analysis, robotic automation, LIS reporting etc.
• Available solution for direct analysis of positive blood cultures. STAT Test Capability.
• CDC-Microbenet Capability.
Mass Spectrometer Features
• Self-contained bench-top linear MALDI TOF mass spectrometer with a footprint not to exceed 20.1 X
26.8 X 43 in and weight not to exceed 185 lbs.
• Powered by a single standard US 110 VAC power cord.
• Self-cleaning ion source via automated software-controlled IR laser heating without breaking vacuum and complete in about 15 minutes (to reduce maintenance and service requirements).
• Gridles ion source for superior ion transfer into the analyzer region.
• 60 Hz nitrogen cartridge laser directed to target via fiber optic cable (to reduce maintenance and service requirements). Includes variable power attenuator and UV optics.
• Oil-free diaphragm roughing pump (for ultra-quiet operation and reduced maintenance and service requirements).
• Patented PANtm technology for high mass resolution over a wide mass range, which minimizes required flight tube length.
• Single computer for instrument control, data acquisition, data analysis and reporting.
• Potential to integrate additional tablet PCs for high-volume workflows.
• Multiple MALDI target plate options including reusable stainless steel 48 and 96 spot or disposable 96 spot configurations.
• Fast (~2 minutes) target loading and removal from instrument (improves overall time-to-result).
• Minimal heat output (1364 BTU/Hr.) avoiding installation of special venting
• Calibration and QC performed on every run http://www.bdal.com/ http://www.bdal.com/
Biotyper RUO Library Features
• RUO Microorganism library with more than 7,800 entries, 2,609 species and 483 genera • Library generated using a single MALDI matrix (HCCA)
• Continuously growing library including one RUO update each year.
• Library containing isolates of clinical, veterinary, food and environmental origin (RUO)
• Open library so that user can add organisms that are not yet represented in the commercial Bruker library.
• Additional Fungi and Mycobacteria libraries available for full coverage of microorganisms (RUO) •
Additional Security library available that includes bioterrorism organisms (RUO)
• Subtyping Module available for resistance detection in S. aureus, B. fragilis, and K. pneumoniae, L. monocytogenes confirmation and M. chimaera/M. intracellular differentiation. (RUO)
Biotyper Accessory Hardware and Software
• Accessory instrument available for performing quality-controlled, automated deposition of the MALDI matrix onto the target plate with seamless integration into the system – Bruker GALAXY
• Accessory instrument available for light-guided manual target preparation using projection to indicate the next position for preparation on the MALDI target with a complete, barcoded and paperless workflow – Bruker PILOT.
• The only system in the market that is compatible with BioMerieux Vitek-II, Beckman Microscan and BD Phoenix
Additional Specifications Unique to Biotyper CA (FDA cleared) instrument
• FDA clearance of 333 microorganisms covering 424 species for FDA instrument
• FDA claim data – overall accuracy 99.78% to genus and 98.19% to species/complex level, misidentifications 0.13% genus and 1.72% species level
• One computer includes FDA Cleared and RUO libraries at no additional charge for FDA instrument
| Bruker Daltonics Inc. is the Manufacturer and Sole Source of the MALD-Biotyper Microorganism Identification System |
| Unique Features of Bruker’s MALDI-Biotyper Microorganism Identification System |
| Mass Spectrometer Features |
| Biotyper RUO Library Features |
| Biotyper Accessory Hardware and Software |
| Additional Specifications Unique to Biotyper CA (FDA cleared) instrument |
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