MALDI Biotyper CA System. Innovation with Integrity. Clinical Application for Identification of Microorganisms MALDI-TOF

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1 Achromobacter xylosoxidans Acinetobacter lwoffii Acinetobacter radioresistens Acinetobacter ursingii Ac netobacter baumannii complex Acinetobacter baumannii Acinetobacter calcoaceticus Acinetobacter noso mialis Acinetobacter pittii Actinomyces oris Aeromonas sp Aeromonas allosaccharophila Aeromonas cav Aeromonas culicicola Aeromonas hydrophila Aeromonas ichthiosmia Aeromonas veronii Aeromonas sobr Alcaligenes faecalis Bacteroides_ovatus group Burkholderia gladioli Burkholderia multivorans Burkholder cepacia complex Burkholderia ambifaria Burkholderia anthina Burkholderia cenocepacia Burkholderia cep Burkholderia diffusa Burkholderia dolosa Burkholderia lata Burkholderia latens Burkholderia metallica Bur eria pyrrocinia Burkholderia seminalis Burkholderia stabilis Burkholderia vietnamiensis Candida dublinien Candida glabrata Citrobacter amalonaticus complex Citrobacter amalonaticus Citrobacter farmeri Citrobac freundii complex Citrobacter braakii Citrobacter freundii Citrobacter gillenii Citrobacter murliniae Citrobac werkmanii Citrobacter youngae Citrobacter rodentium Citrobacter sedlakii Citrobacter koseri Corynebacte bovis Corynebacterium amycolatum Delftia_acidovorans group Eikenella corrodens Enterobacter aerogen terobacter cloacae complex Enterobacter asburiae Enterobacter cancerogenus Enterobacter cloacae Enter ter hormaechei Enterobacter kobei Enterobacter ludwigii Enterococcus gallinarum Escherichia coli Finego magna Geotrichum capitatum Haemophilus haemolyticus Haemophilus influenzae Haemophilus parainflu zae Hafnia alvei Klebsiella pneumoniae Klebsiella_oxytoca / Raoultella_ornithinolytica Kingella kingae Koc kristinae Moraxella_sg_Branhamella catarrhalis Moraxella_sg_Moraxella osloensis Morganella morganii P toea agglomerans Parabacteroides distasonis Parabacteroides distasonis Pasteurella multocida Pediococc pentosaceus Propionibacterium acnes Proteus mirabilis Proteus vulgaris group Proteus hauseri Proteus pe Proteus vulgaris Providencia rettgeri Providencia stuartii Pseudomonas aeruginosa Pseudomonas fluoresc group Pseudomonas oryzihabitans Pseudomonas azotoformans Pseudomonas brenneri Pseudomonas ce Pseudomonas congelans Pseudomonas corrugata Pseudomonas extremorientalis Pseudomonas fluoresc Pseudomonas gessardii Pseudomonas libanensis Pseudomonas mandelii Pseudomonas marginalis Pseud nas migulae Pseudomonas mucidolens Pseudomonas orientalis Pseudomonas poae Pseudomonas rhodes Pseudomonas synxantha Pseudomonas tolaasii Pseudomonas trivialis Pseudomonas veronii Pseudomona putida group Pseudomonas fulva Pseudomonas monteilii Pseudomonas mosselii Pseudomonas plecoglos Pseudomonas putida Rothia dentocariosa Rothia mucilaginosa Salmonella sp Salmonella enterica ssp ariz Salmonella enterica ssp bongori Salmonella enterica ssp diarizonae Salmonella enterica ssp enterica Salm la enterica ssp houtenae Salmonella enterica ssp indica Salmonella enterica ssp salamae Serratia rubidae ratia liquefaciens Serratia marcescens Stenotrophomonas maltophilia Streptococcus agalactiae Streptoco anginosus Streptococcus constellatus Streptococcus dysgalactiae Streptococcus gallolyticus Streptococc gordonii Trichosporon asahii Vibrio parahaemolyticus Vibrio vulnificus Yersinia enterocolitica Yersinia pse MALDI Biotyper CA System Clinical Application for Identification of Microorganisms Innovation with Integrity MALDI-TOF

2 In Microbiology, Speed and Accuracy Matters The MALDI Biotyper CA System A powerful technology for better results To help answer key challenges in Clinical Microbiology, Bruker has utilized its many years of experience to create the truly groundbreaking MALDI Biotyper CA System. With its combination of performance and utility, the MALDI Biotyper CA System is revolutionizing the way laboratories are performing microbial identifications for clinically significant gram negative bacteria, gram positive bacteria and yeast in the clinical microbiology laboratory. Accuracy comparable to Nucleic Acid Sequencing Much faster than traditional methods Cost effective Robust and easy to use A true benchtop system Identifying microorganisms by their molecular fingerprint The MALDI Biotyper CA System identifies microorganisms using MALDI-TOF (Matrix Assisted Laser Desorption Ionization Time of Flight) mass spectrometry to measure a unique proteomic fingerprint of an organism. Specifically, the MALDI Biotyper CA System measures highly abundant proteins that are found in all microorganisms. The characteristic patterns of these highly abundant proteins are used to reliably and accurately identify a particular microorganism by matching the respective pattern with an extensive FDA-cleared library to determine the identity of the microorganism.

3 A Simple Procedure for a Sophisticated Platform Innovative design leads to enhanced performance and productivity The MALDI Biotyper CA System workflow has been designed to be as robust and easy to perform as possible. No previous experience with mass spectrometry is required. The fully traceable workflow has been streamlined and requires only a few simple steps to generate high quality microorganism identifications as shown below. Typically no more than an isolated single colony from a culture is required. The entire process needs only a few minutes to complete. Our dedicated microbiology software automates the process of acquiring the mass spectrum and performing the match against the extensive FDA cleared reference library. The result is very easy to interpret and presented as a traffic light color scheme. Transfer sample and add matrix Select an isolated colony Export result to AST/LIS MALDI Biotyper CA System Sample Workflow Add to MALDI-TOF project list Software automatically generates MALDI-TOF spectrum Final review by microbiologist Spectrum instantly matched against reference library to give identification

4 Easy to Use Software that is Dedicated to Microbiology In just a few steps, the simple-to-use software guides users through the set-up of samples for analysis. Automatic Calibration and Quality Control Check The MALDI Biotyper CA System microflex LT/SH mass spectrometer is automatically checked using US IVD BTS (Bacterial Test Standard) before each use. When the check is successful, the system automatically begins the measurement process. Clear identification results display at species level After the acquisition of the spectral data has been completed, a report is generated. The result for each sample shows the best match along with the respective matching score. Organism identification hints can also be viewed via a hyperlink.

5 Rigorous and Sophisticated Data Analysis Assures Accuracy Meaning of score values The spectrum of the unknown test organism, acquired through the MALDI Biotyper CA System Software, is electronically transformed into the peak list. Using a biostatistical algorithm, this peak list is compared to reference peak lists of organisms in the reference library and a log(score) value between 0.00 and 3.00 is calculated. The higher the log(score) value, the higher the degree of similarity to a given organism in the reference FDA-cleared library. A log(score) value of 2.00 can be considered an excellent probability for test organism identification at the species level. The main spectra concept: a reference library developed with the user in mind Score Values Reference Strain Reference library entries in the MALDI Biotyper CA System are stored as Main Spectra (MSP). These MSPs are based on multiple measurements of a single defined strain to ensure that the true biological variability of an organism has been captured. An unbiased sophisticated algorithm creates the MSP completely unsupervised by extracting information about peak position, intensity and frequency, while employing very effective denoising and patented mass corrections to the peak data. Unknowns are then compared to the MSP FDA-cleared library using a superior pattern-matching approach that is based on true statistical multi-variant analysis; and includes peak positions, intensities and frequencies ensuring the highest possible levels of accuracy and reproducibility across the complete range of microorganisms.

6 The Best Technology from the Experts in Mass Spectrometry As the leader in MALDI-TOF technology, it is of great importance to Bruker to design a robust, compact, high performance platform intended for extensive and routine use in the microbiology laboratory.the core of the MALDI Biotyper CA system is the cutting-edge microflex LT/SH MALDI-TOF mass spectrometer. A true bench-top solution A low-noise operating system with low weight of approximately185 lbs and requiring less than 3 feet of counter space offers flexibility in meeting laboratory needs for compact systemsolutions. The MALDI Biotyper CA System only needs a 110 V electrical outlet which results in very minimal heat output. Resolution meets sensitivity Resolution and sensitivity of the spectrometer are tailored to the needs of microbiologists. For optimal results without the need for unnecessarily long and bulky instrument flight tubes. Accelerated data acquisition At approximately 200 identifications per hour, the system offers the highest throughput for MALDI-TOF microbiology testing. Highly reproducible results run to run The quick and simple Bacterial Test Standard quality check performed before each run provides the highest standard of reproducibility. Continuous operation Routine maintenance such as cleaning is reduced to a minimum and can be easily performed by the user.

7 The MALDI Biotyper CA System Components The standard MALDI Biotyper CA System contains the following components: microflex LT/SH mass spectrometer [P/N: ] MALDI Biotyper CA System desktop computer running under Windows 7 [P/N: ] MALDI Biotyper CA System software [P/N: ] US IVD 48 Spot target [P/N: ] US IVD BTS [P/N: ] US IVD HCCA portioned [P/N: ] Package Insert, MALDI Biotyper CA System User Manual [P/N: ] Uninterruptible Power Supply (UPS) [P/N: ] Intended Use The Bruker Daltonics, Inc. MALDI Biotyper CA System is a mass spectrometer system using matrix-assisted laser desorption/ionization time-of-flight (MALDI-TOF) for the identification of microorganisms cultured from human specimens. The MALDI Biotyper CA System is a qualitative in vitro diagnostic device indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and yeast infections Dimensions & Operating Parameters LxWxH: [20.1 x 26.8 x 43 ] Weight: (185 lb) net weight Noise: < 50 db under normal operating conditions Operating Temp Range: (50-86ºF) Operating Humidity: 15-85% F

8 The following organisms are claimed Achromobacter xylosoxidans Acinetobacter baumannii complex [4] Acinetobacter haemolyticus Acinetobacter johnsonii Acinetobacter junii Acinetobacter lwoffii Acinetobacter radioresistens Acinetobacter ursingii Actinomyces meyeri Actinomyces neuii Actinomyces odontolyticus Actinomyces oris Aerococcus urinae Aerococcus viridans Aeromonas sp [7] Alcaligenes faecalis Anaerococcus vaginalis Bacteroides fragilis Bacteroides uniformis Bacteroides ovatus group Bacteroides thetaiotaomicron group Bacteroides vulgatus group Bordetella group [3] Bordetella hinzii Brevibacterium casei Brevundimonas diminuta group Burkholderia cepacia complex [13] Burkholderia gladioli Burkholderia multivorans Campylobacter coli Campylobacter jejuni Campylobacter ureolyticus Candida albicans Candida boidinii Candida dubliniensis Candida duobushaemulonii Candida famata Candida glabrata Candida guilliermondii Candida haemulonis Candida inconspicua Candida kefyr Candida krusei Candida lambica Candida lipolytica Candida lusitaniae Candida metapsilosis Candida norvegensis Candida orthopsilosis Candida parapsilosis Candida pararugosa Candida pelliculosa Candida tropicalis Candida valida Capnocytophaga ochracea Capnocytophaga sputigena Chryseobacterium gleum Chryseobacterium indologenes Citrobacter amalonaticus complex Citrobacter freundii complex Citrobacter koseri Clostridium difficile Clostridium perfringens Corynebacterium amycolatum Corynebacterium bovis Corynebacterium diphtheriae Corynebacterium glucuronolyticumum Corynebacterium jeikeium Corynebacterium kroppenstedtii Corynebacterium macginleyii Corynebacterium minutissimumm Corynebacterium propinquum Corynebacterium pseudodiphtheriticum Corynebacterium riegelii Corynebacterium tuberculostearicum Corynebacterium ulcerans Corynebacterium urealyticum Corynebacterium xerosis Corynebacterium aurimucosum group Corynebacterium striatum group Cronobacter sakazakii group Cryptococcus gattii Cryptococcus neoformans var grubii Cryptococcus neoformans var neoformans Cupriavidus pauculus group Delftia acidovorans group Dermacoccus nishinomiyaensis Edwardsiella tarda Eikenella corrodens Elizabethkingia meningoseptica group Enterobacter aerogenes Enterobacter amnigenus Enterobacter cloacae complex Enterococcus casseliflavus Enterococcus faecalis Enterococcus faecium Enterococcus gallinarum Enterococcus hirae Enterococcus avium group Escherichia coli Finegoldia magna Fusobacterium canifelinum Fusobacterium necrophorum Fusobacterium nucleatum Gardnerella vaginalis Gemella haemolysans Gemella sanguinis Geotrichum candidum Geotrichum capitatum Granulicatella adiacens Haemophilus haemolyticus Haemophilus influenzae Haemophilus parainfluenzae Haemophilus parahaemolyticus group Hafnia alvei Kingella kingae Klebsiella pneumoniae Klebsiella oxytoca / Raoultella ornithinolytica Kloeckera apiculata

9 Kocuria kristinae Kytococcus sedentarius Lactococcus garvieae Lactococcus lactis Leuconostoc mesenteroides Macrococcus caseolyticus Micrococcus luteus Moraxella sg Branhamella catarrhalis Moraxella sg Moraxella nonliquefaciens Moraxella sg Moraxella osloensis Morganella morganii Myroides odoratimimus Myroides odoratus Oligella ureolytica Oligella urethralis Pantoea agglomerans Parabacteroides distasonis Pasteurella multocida Pediococcus pentosaceus Peptoniphilus harei group Peptostreptococcus anaerobius Pichia ohmeri Plesiomonas shigelloides Porphyromonas gingivalis Prevotella bivia Prevotella buccae Prevotella denticola Prevotella intermedia Prevotella melaninogenica Propionibacterium acnes Proteus mirabilis Proteus vulgaris group Providencia rettgeri Providencia stuartii Pseudomonas aeruginosa Pseudomonas fluorescens group Pseudomonas oryzihabitans Pseudomonas putida group Pseudomonas stutzeri Rhizobium radiobacter Rothia aeria Rothia dentocariosa Rothia mucilaginosa Saccharomyces cerevisiae Salmonella sp Serratia liquefaciens Serratia marcescens Serratia plymuthica Serratia rubidaea Staphylococcus aureus Staphylococcus auricularis Staphylococcus capitis Staphylococcus caprae Staphylococcus carnosus Staphylococcus cohnii Staphylococcus epidermidis Staphylococcus equorum Staphylococcus felis Staphylococcus haemolyticus Staphylococcus hominis Staphylococcus lugdunensis Staphylococcus pasteuri Staphylococcus pettenkoferi Staphylococcus pseudintermedius Staphylococcus saccharolyticus Staphylococcus saprophyticus Staphylococcus schleiferi Staphylococcus simulans Staphylococcus vitulinus Staphylococcus warneri Stenotrophomonas maltophilia Streptococcus agalactiae Streptococcus anginosus Streptococcus constellatus Streptococcus dysgalactiae Streptococcus gallolyticus Streptococcus gordonii Streptococcus intermedius Streptococcus lutetiensis Streptococcus mutans Streptococcus pneumoniae Streptococcus pyogenes Streptococcus salivarius Streptococcus mitis oralis group Sutterella wadsworthensis Trichosporon asahii Vibrio parahaemolyticus Vibrio vulnificus Yersinia enterocolitica Yersinia pseudotuberculosis

10 MBT CA System Consumables US IVD Bacterial Test Standard (BTS) The BTS is an E.coli extract spiked with two high molecular weight proteins and has been developed for the quality control process of the MALDI Biotyper CA System. Its specific composition covers the entire mass range of proteins used by MALDI Biotyper CA System for precise identification of microorganisms. Contents: One box consisting of 5 tubes providing approximately 40 spots per tube / Part No US IVD HCCA (alpha-cyano-4-hydroxycinnamic acid) Matrix (HCCA) The instant HCCA matrix enables easy and convenient preparation of HCCA matrix solutions. The matrix is soluble in standard organic solvent, stable, is easy to handle, and enables highly sensitive measurements. Contents: One box consisting of 10 tubes providing approximately 250 samples per tube / Part No US IVD 48 Spot Target Reusable polished steel target with barcode for MALDI- TOF-MS providing 48 sample spots. The barcode supports full traceability in paperless workflows. One target / Part No

11 Notes

12 Bruker Daltonics is continually improving its products and reserves the right to change specifications without notice. BDAL , , Revision B MALDI Biotyper is a registered trademark of Bruker Daltonik GmbH in the European Union and USA. Bruker Daltonics Inc. Billerica, MA USA Phone +1 (978) Fax +1 (978) ms.sales.bdal@bruker.com