MBT Sepsityper Kit US IVDenables rapid, specific detection of many cases of bacteremia-induced sepsis to assist infectious disease specialists in potentially life-saving decisionsUsed for MALDI Biotyper®(MBT)identification directly from Positive Blood Cultures (PBC) with short time-to-result (TTR) of less than 30 minutesUS FDA clearance received in late December for diagnostic use onMALDI Biotyper CA Systemwith library of 425 organisms, covering gram-positive and gram-negative bacteria, as well as yeasts, e.g. Candida auris
Bruker Corporation (Nasdaq: BRKR) today announce US FDA clearance and the US launch of theMBT Sepsityper Kit US IVDfor rapid microbial identification of more than 425 microorganisms from positive blood cultures on theMALDI BiotyperCASystem.
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Figure 1: Ike Northern, Director of Infectious Disease Testing and Immunology, CompuNet Clinical Laboratory (Photo: Business Wire)
Dr. Wolfgang Pusch, Executive Vice President Microbiology & Diagnostics at Bruker Daltonics, stated: “This represents an order of magnitude increase in the number of microorganisms that can be identified rapidly from positive blood cultures in suspected bacterial or fungal sepsis cases compared to targeted PCR detection. This could make theMBT Sepsityper Kit US IVDa nearly universal, rapid sepsis identification solution for clinical microbiology. We expect this affordable fast assay to benefit large numbers of patients, as it comes at a fraction of the cost of expensive syndromic panels with limited species coverage. Faster identification can assist infectious disease physicians and pharmacists in switching sepsis patients to appropriate antibiotics or antifungals for local or hospital infection patterns, which reduces costs, length of ICU stays and could save lives.”
TheMBT Sepsityper Kit US IVDenables the rapid identification of many microorganisms from positive blood culture bottles. Harvested microorganisms are processed, and then identified using the FDA-clearedMALDI Biotyper CASystem, with a reference library that covers 425 different gram-negative and gram-positive bacterial species and groups, as well as yeasts, includingCandida auris, an emerging pathogen for hospital-acquired candidiasis.
TheMBT Sepsityper Kit US IVDworkflow typically takes less than 30 minutes from a positive blood culture bottle alert to identification. It can save up to 24 hours in time-to-result (TTR) for many identifications, versus additional agar plate culturing, and a further 8–12 hours for biochemical identification after agar plate culturing. TheMBT Sepsityper Kit US IVDworkflow does not test for resistance or antibiotic susceptibility. It rapidly identifies the microbial species once the blood culture system has detected microbial growth.
Mr. Ike Northern, Director of Infectious Disease Testing and Immunology at the CompuNet Clinical Laboratory in Dayton, Ohio, explained: “I think a lot of laboratories are realizing that they need to use MALDI-TOF MS technology for microbial identification. Many are now making this investment when they recognize the long-term patient and cost benefits. TheMBT Sepsityper Kit US IVDwill be the next step for a lot of clinical microbiology laboratories. Many are currently using multiplex PCR tests, but once you have theMALDI Biotyperinstrument, it is more cost-effective to use theMBT Sepsityper Kit US IVDfor fast identification than PCR syndromic panels.” (*)
Rapid testing from positive blood cultures is gaining increasing interest in the clinical microbiology community due to high mortality and morbidity rates in sepsis and septic shock. Sepsis impacts an estimated 30 million patients worldwide every year, many of whom die or suffer permanent health issues. Survival rates can be increased by rapid initiation of an appropriate antibiotic therapy ( http://www.worldsepsisday.org ). Developed for use with Bruker's U.S. FDA-clearedMALDI Biotyper CA System, theMBT Sepsityper Kit US IVDis intended to simplify and speed up identification of microorganisms directly from positive blood cultures of sepsis patients.
Dr. Elisabeth C. Shearon, the Medical Director at Alverno Laboratories in Hammond, Indiana, commented: “Rapid (MBT)Sepsityperidentification has become instrumental in terms of our patient care. Especially in critically ill patients, the improved turn-around-time allows disease specific treatment which conserves health-care resources and, most importantly, improves patient outcomes.” (*)
Currently, guidelines call for physicians to treat septic patients quickly with broad-spectrum antibiotics with the goal of switching to a more targeted therapy once the infecting organisms have been identified and/or any antibiotic resistances have been determined. TheMBT Sepsityper Kit US IVDcan improve this process by providing rapid microbial identifications to help clinical microbiologists, treating physicians, and patients alike.
Dr. Steven D. Burdette, the Chief of Infectious Diseases at the Miami Valley Hospital in Dayton, Ohio added: “TheMBT Sepsityperkit data has allowed us to adjust antibiotic therapy according to our local antibiogram. This, at times, has allowed us to narrow or stop certain antibiotic treatments while in other cases, it has allowed us to escalate antibiotic coverage pending sensitivity data. It has become a crucial tool for our Antimicrobial Stewardship team.” (*)
* All quoted early adopters have self-validated the research-use-only (RUO) version of theMBT Sepsityperkit prior to FDA-clearance of theMBT Sepsityper Kit US IVD.
About the BrukerMALDI Biotyper®(MBT) Platform
TheMALDI Biotyper®enables molecular identification of bacteria, yeasts and fungi. Classification and identification of microorganisms is achieved reliably and quickly using proteomic fingerprinting by high-throughput MALDI-TOF mass spectrometry. TheMALDI Biotyperuses a molecular approach based on specific proteomic fingerprints from bacterial strains. Many published studies have highlighted the greater accuracy and lower cost, as well as the typically much faster time-to-result (TTR).
Applications of variousMALDI Biotypersolutions include clinical routine microbial identification, environmental and pharmaceutical analysis, taxonomical research, food and consumer product safety and quality control, as well as marine microbiology. In many European and international laboratories, theMALDI Biotyperhas replaced classical biochemical testing for bacterial identification in the past few years due to the accuracy, speed, extensive species coverage, ease of use and cost effectiveness of the system. Traditional biochemical techniques detect different metabolic properties of microorganisms, can take many hours or even days for completion, and they often lack specificity.
The robustMALDI Biotyperrequires minimal sample preparation and offers low consumables cost. The products of theMALDI Biotyperfamily are available in a research-use-only (RUO) version, as the U.S. FDA-clearedMALDI Biotyper CA System, or in an IVD-CE version according to EU directive EC/98/79. TheMALDI Biotyperalso has medical device registrations in numerous other countries.
RUO versions of theMALDI Biotypersoftware allow selected, high-value antimicrobial resistance tests. The CE-IVDMBTSTAR®-Cephakit now allows rapid, functionalantibiotic resistance testing againstCephalosporins,and the CE-IVDMBT STAR-Carbakit is for fastCarbapenem-resistance testing.
About Bruker Corporation(Nasdaq: BRKR)
Bruker is enabling scientists to make breakthrough discoveries and develop new applications that improve the quality of human life. Bruker’s high-performance scientific instruments and high-value analytical and diagnostic solutions enable scientists to explore life and materials at molecular, cellular and microscopic levels. In close cooperation with our customers, Bruker is enabling innovation, improved productivity and customer success in life science molecular research, in applied and pharma applications, in microscopy and nanoanalysis, and in industrial applications, as well as in cell biology, preclinical imaging, clinical phenomics and proteomics research and clinical microbiology. For more information, please visit: www.bruker.com .