1095969 Brand Name Justification for Bruker BioSpin Biotyper_redacted.pdf

US Department of Agriculture (USDA)

Brand Name Justification Exceeding Simplified Acquisition Threshold

Contents Section 1: Single Source or Brand Name Justification

1.1 Identification of the Agency and Contracting Activity

1.2 Description of the Supplies or Services Required to Meet the Agency’s Needs

1.3 Circumstances and Rationale for Limiting Competition

1.4 Description of the Market Research Conducted Among Schedule Holders and the Results or a Statement of the Reason Market Research Was Not Conducted

1.5 Estimated Price, Including All Options, If Applicable

1.6 Recommended Source(s)

Section 2: Certifications and Approvals

2.1 Program or Technical Personnel

2.2 Contracting Officer

Section 3: Notes and Guidance ................................................................................................ Error! Bookmark not defined.

Section 1: Brand Name Justification

1.1 Identification of the Agency and Contracting Activity

USDA/APHIS/VS/D&B/NVSL/BI purchase of a Bruker MALDI Biotyper Sirius RUO (Research Use Only) Machine and associated items.

1.2 Description of the Supplies or Services Required to Meet the Agency’s Needs

#1890102 MALDI Biotyper® sirius RUO System (Research use Only):

MALDI Biotyper sirius is a benchtop MALDI-Time-Of-Flight Mass Spectrometer labeled |for research use only| for accurate mass determination of bio-molecules. Includes gridless microSCOUT™ MALDI ion source with extended pulsed ion extraction PAN™ mass range focusing; integrated source cleaning without the need of venting the system; 200 Hz BRUKER smartbeam™ solid-state lifetime** laser; TOF analyzer for linear-only measurements with positive or negative acceleration potential.

**Lifetime means: 500 Million laser shots or seven years after acceptance (whatever comes first)

# 1863930 Computer System MBT sirius/Win10- Includes a data system with digitizer, WIN10 Operating System, LCD-display, Keyboard, Mouse, bar code scanner with holder and an Acronis True Image DVD including one license.

# 1863936 Cable set Computer/MBT Sirius- Interfacing the computer system with the Bruker mass spectrometer.

# 1847032 MBT Shuttle- The MBT Shuttle target holder is used to securely hold MSP steel MALDI target plates or MBT Biotargets during the sample preparation process. The secure grip and ergonomic form make sample preparation easier. Three mounting positions are provided for reagent containers.

# 1840375 MBT Biotarget 96- Disposable target plate for MALDI Biotyper workflow to enable microorganism detection and identification. Allows to prepare 96 samples on each target plate. Quantity of 20 target plates in one box.

# 8267615 MSP adapter for MALDI Biotarget (2 pieces)- Adapter enables the use of MALDI Biotarget in a Bruker mass spectrometer.

# 8280800 MSP 96 target polished steel- BC Reusable steel target plate with 96 sample positions.

# 8242974 Prepared MSP-Target required for installation

# 1829023 MBT Compass Library- The MALDI Biotyper (MBT) Compass Library contains 8468 MSP reference spectra from exactly defined microorganism from industrial, veterinary and clinical isolates provided by collaborating partners, round robin strains and strains from isolates from accredited ISO 9001:2008 certified strain collections.

# 8255344 Bruker Matrix HCCA, portioned Purified matrix substance for MALDI-TOFMS. alpha-cyano-4-hydroxycinnamic acid C10H7NO3 M 189.17 - CAS 28166-41-8 Content: 10 tubes à 2.5 mg HCCA To be stored at 2-8 C (35-46 F) For research use only. Not for use in diagnostic procedures.|

# 8255343 Bruker Bacterial Test Standard, 5 Tubes Mass calibration standard showing a typical Escherichia coli DH5 alpha peptide and protein profile plus additional proteins in MALDI-TOF MS. Content: 5 tubes, each tube sufficient for approximately 40 MALDI target plate spots. Store at -18 C or below. |For research use only. Not for use in diagnostic procedures.| Additionally, a MALDI Biotyper specific software, a system installation, a familiarization upon installation, 1-year warranty, and two days on-site MALDI Biotyper application training are included.

# 1863936 Cableset Computer/MBT Sirius

# 8605553 UPS POWERVAR ABCE602-11- 120VAC

# 1890605 MBT Compass HT- The MBT Compass HT software is a bioinformatics package for use with the Bruker MALDI Biotyper, for microorganism identification and classification based on MALDI-TOF MS profile spectra, offering high throughput (HT) identification rates. The MBT Compass HT software is performing the data processing from raw spectra to peak lists. Microorganism identification is subsequently done by pattern matching between reference spectra in the MBT Libraries and new, unknown MALDI- TOF profiles acquired on the MALDI Biotyper system. Contains one license for the MBT Compass HT Server and one MBT Compass HT Client each.

# 1828476 MBT Explorer Module- The MBT Explorer Module allows sophisticated statistical analysis as well as the extension of existing libraries or the creation of new libraries. Statistical analysis is supported by PCA (Principal Component Analysis), Clustering (dendrogram creation and examination) and correlation analysis based on a composite correlation index (CCI) matrix approach. The module allows a detailed comparison of measured spectra with the archived library spectra.

1.3 Circumstances and Rationale for Limiting Competition

The current machine is reaching end of life and new machine is needed to perform daily diagnostic testing in DBPL-BI. This replacement machine must provide the same type, quantity, and quality of tests as the machine it’s replacing, while not exceeding the allotted footprint.

Bruker BioSpin Corp is the only manufacturer of the MALDI Biotyper Sirius RUO machine.

1.4 Description of the Market Research Conducted Among Schedule Holders and the Results or a Statement of the Reason Market Research Was Not Conducted

Bruker has several comparable models available:

The ‘CA’ models are for human clinical labs. The database is much smaller and targeted to bacteria and yeast which are pathogenic to humans, whose spectra have been cleared by the FDA.

MALDI Biotyper Sirius one CA System- intended for human clinical labs; positive ion mode only

MALDI Biotyper Sirius CA System- intended for human clinical labs

The ‘RUO’ (research use only) model has a much larger validated database for bacteria and yeast, can identify molds, and allows for users to create and/or download unique spectra libraries to identify other organisms that are not present in the provider’s database. It can also be expanded to include mycobacteria identification.

MALDI Biotyper Sirius one RUO or GP System- Positive ion mode only

Competitors with comparable products include:

bioMerieux (in collaboration/D.B.a Shimadzu and Kratos)- No comparable benchtop models and no floor space to accommodate larger unit. Additionally, this business’s organism identification library includes less than half of the bacteria species that are included in Bruker’s library, which could lead to