However, application of this technique in microbial surveillance outside of clinical settings is limited. The maldi8020 is the latest in a long line of malditof products from shimadzu. Maldi biotyper integrates a readytouse reference library comprising thousands of individual strains and is growing continuously. The recent clearance adds 170 species and species groups, representing 180 clinicallyrelevant species of aerobic gram positive, fastidious gram negatives, enterobacteriaceae. A side by side comparison of bruker biotyper and vitek ms. Many outstanding features have been incorporated into the maldi biotyper ca system to enhance performance. Each panel contains 2 stiks of each recommended strain refrigerated storage is easy and economical online certificate of analysis provides detailed strain information.
Bruker introduces important maldi biotyper enhancements at. Designed with ease of use as a focal point, this bacterial identification and antimicrobial susceptibility testing idast system provides streamlined workflows and enhanced performance. As lab space is known to be limited, the maldi biotyper sirius ca system incorporates a decade of development in a true benchtop system of only 75 kg, allowing for easy implementation in every lab. Expansion and improvement of malditof ms databases for. Bruker announces expanded fda clearance for maldi biotyper. Bruker today announced that it has received 510k clearance from the us food and drug administration for library and methods expansion for the maldi biotyper ca system, sold in the u. This direct interface eliminates manual transcription errors and additional lislims interfacing via serial port or file exchange connection. At present, two commercial platforms are used in the clinical laboratory. Results generated by the maldi biotyper ca system were compared to 16s rrna molecular sequencing for bacteria and its sequencing for. Ruo versions of the maldi biotyper allow selected, highvalue. The maldi biotyper system with powerful technology for better results. Classification and identification are based on proteomic fingerprinting using highthroughput malditof mass spectrometry. The numbers of genus and species level anaerobe entries for the most recent fdacleared and ruo vitek and bruker databases are listed in table 2.
Bruker introduces new products for diagnosis and susceptibility testing of invasive fungal diseases. Numerous studies have demonstrated the higher accuracy, faster timetoresults, and. The dxm microscan walkaway microbiology system delivers trusted detection of emerging and critical antimicrobial resistance with goldstandard 1 mic accuracy. Electronic flow control defc or manual detector types. Bruker corporation bruker introduces betalactamase. The expansion means that the system can identify 210 species or species groups, spanning 280 bacteria and yeast species, and covering more than 98 percent of the typical bacteria identification. The maldi biotyper ca system is a qualitative in vitro diagnostic devices indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and yeast infections. Maldi biotyper systems provide highspeed, highconfidence identification and taxonomical classification of bacteria, yeasts, and fungi. Accessgudid maldi biotyper smart ca 0084159431 biotyper system for clinical use in the usa, with smart laser. Evaluation of the bruker maldi biotyper for identification. Phase 2 data confirms that closely related species can be unambiguously identified by the maldi biotyper ca system. The bruker biotyper, bd phoenix and bd bactec integration via bd epicenter provides the most complete stateoftheart system for all microbiology laboratories.
Fda clearance under section 510k to market its maldi biotyper ca system in the. Wear appropriate protective clothing, including safety glasses and gloves, when. Studies were conducted to determine the stability of unreconstituted matrix as well as inuse reconstituted matrix. Maldi biotyper smart ca system is a mass spectrometer system using matrixassisted laser desorption ionization timeofflight malditof for the. This costeffective system is much faster than traditional methods and provides the ideal complement to the microscan walkaway plus system. The system is fully compatible with the existing fdacleared maldi biotyper software, microorganism reference library and consumables for microbial identification. In this study, we successfully developed a simplified extraction procedure for the analysis of mycobacteria using the bruker biotyper malditof ms system. The maldi biotyper ca system has been granted usa fda clearance under section 510 k for the identification of gram negative and gram positive bacteria, anaerobic bacteria and yeast cultured from human specimens.
Contact us maldi biotyper ca systems overview maldi. Malditof ms, maldi biotyper ca system, bruker daltonics, page 2 of 9 billerica, ma. The bruker maldi biotyper system is an industryleading microbiology system used for rapid microbial identification. The maldi biotyper also has medical device registrations in numerous other countries. This benchtop, linear malditof mass spectrometer delivers outstanding performance in a compact footprint, making it an ideal choice for todays increasingly demanding laboratories. In this study, we conducted a multicenter evaluation of the maldi biotyper ca mbtca system bruker daltonics inc, billerica, ma for the identification of aerobic gramnegative bacteria as part of a 510k submission to the fda. Hcca portioned matrix stability iicca portioned matrix is used when processing test organisms for identification on the maldi biotyper ca system. The maldi biotyper ca system is a mass spectrometer. This manual is intended to contain all information necessary for successful operation of the sherlock system. Fid flame ionization detector tcd thermal conductivity detector ecd. Both instruments connect to the bd phoenix m50 system providing an integrated solution for identification and susceptibility testing.
Fdacleared maldi biotyper ca system, or in an ivdce. Fda grants brukers maldi biotyper ca system second. In this study, we have evaluated the performance of a bruker maldi biotyper system for the identification of. Bruker announces fda clearance for second, expanded claim. Multicenter evaluation of the bruker maldi biotyper ca. The maldi biotyper ca system is automatically checked using us ivd bacterial test standard bts before each use. The system is open and can be easily expanded by specific requests of the user including data for id of bacteria, yeasts and fungi. Bruker corporation announces fda clearance to market the. Fdacleared maldi biotyper ca system, or in an ivdce version according to eu directive ec. Bd bruker maldi biotyper provides a fully integrated microbiology solution. Fdacleared maldi biotyper ca system, or in an ivdce version according to eu directive ec9879. In just a few steps, the simpletouse software guides users through the setup of samples for analysis. Bruker announces us fda clearance of expanded 3rd claim.
Market leader in malditof the maldi biotyper ca system was developed by bruker, the industry leader in malditof technology. This provides an ideal idast solution for clinical microbiology labs. The bd bruker maldi biotyper is a bench top system and has over 400 organisms available in. Bruker maldi biotyper ca system gram positive identification panel, by microbiologics. Routine use of malditof ms for anaerobic bacterial.
Maldi biotyper systems mass spectrometry and separations. The products of the maldi biotyper family are available in a researchuseonly ruo version, as the u. Full integration of maldi id and bd phoenix ast into the bd epicenter bdxpert system. When the check is successful, the system automatically begins the measurement process. With its combination of performance and utility, the maldi biotyper. The new claim includes a significant expansion of the microbial reference library for.
Bruker introduces additional key products for diagnosis. Fly reservoir associated with wohlfahrtiimonas bacteremia in a human. Bought biotyper library for bacterial id machine pm. We evaluated the bruker maldi biotyper system by analyzing 190 wellcharacterized clinical gpr isolates, including 64 species from 21 genera see table s1 in the supplemental material. As expected, this methodology displays low performance in identifying unusual achromobacter species alby et al. Maldi biotyper sirius ca system the sirius solution. Touched maldi plate to agar incubated anaerobic and aerobic conditions standard bacteria nonspore formers.
We carried out a side by side comparative evaluation of the performance of bruker biotyper versus vitek ms for identification of a large and diverse collection of. Malditof for the identification of microorganisms cultured from human specimens. Scion 456gc bruker daltonics pdf catalogs technical. The maldi biotyper smart ca system identifies microorganisms using maldi tof matrixassisted laser desorption ionizationtime of flight mass spectrometry to determine the unique proteomic fingerprint of an organism. Bruker announces us fda clearance of expanded 3rd claim for maldi biotyper. The approval of brukers ivd maldi biotyper system will further promote the development of clinical microbiology science in the country, not only in laboratory medicine, but also for infection control work within the hospitals. Brukers maldi biotyper ca system, an in vitro diagnostic for clinical microbiology, has received 510k clearance for library and methods expansion, the billerica, mass. Protein fingerprinting and barcoding for bacterial. Supplementary table 1 lists the specific organisms included within each database.
Together with the dxm microscan walkaway system, the bruker maldi biotyper can provide a rapid and accurate solution for id and ast testing. There are a variety of malditof ms systems and databases available for use by clinical laboratories table 2 and supplementary table 1. Protein fingerprinting and barcoding for bacterial identification and classification using maldi biotyper 1. It is assumed that a technician, qualified by midi inc. Comparison of the bruker biotyper and vitek ms matrix. A total of 2,263 aerobic gram negative bacterial isolates were tested representing 23 genera and 61 species. The mbt smart ca system is indicated for use in conjunction with other clinical and laboratory findings to aid the diagnosis of bacterial and fungal infections. In the last 2 years, maldi biotyper ca system bruker daltonics inc.
Quickswitch valve option instantly switch between injectorscolumns and detectors configurations. Fda cleared maldi biotyper ca system, or in an ivdce version according to eu directive ec9879. The combination of these two proven technologies, the bd phoenix system and the bruker maldi biotyper, and data management through the bd epicenter system, will provide laboratorians with a new approach to identification and susceptibility. Matrixassisted laser desorptionionisation time of flight mass. This procedure involves substantially less manipulation and handson time than either the manufacturerrecommended procedure 21, 22 or other previously published procedures 18, 19. Numerous studies have demonstrated the higher accuracy. Bruker announces further portfolio expansion for microbial. Malditof ms has revolutionized the identification of microorganisms and has become an indispensable part of routine diagnostics in the clinical microbiological laboratory.
The bd bruker maldi biotyper is available in ca and ca smart options. These systems were designed as robust, compact, high performance platforms intended for extensive and routine usage. Intended use the maldi biotyper ca system is a mass spectrometer system using matrixassisted laser desorption ionization time of flight malditof for the identification of microorganisms cultured from human specimens. Bruker daltonics, billerica, ma for the identification of clinically important bacteria. Each panel features the userfriendly kwikstik format. Before using the instrument, read all warnings presented in the beginning of this manual. Matrixassisted laser desorption ionizationtime of flight mass spectrometry malditof ms has emerged as a rapid, highly accurate, and costeffective method for routine identification of a wide range of microorganisms.
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