Bruker IntroducesMBT Sepsityper®Kit US IVDfor Rapid and Affordable Identification of over 400 Microorganisms from Positive Blood Cultures
Bruker IntroducesMBT Sepsityper®Kit US IVDfor Rapid and Affordable Identification of over 400 Microorganisms from Positive Blood Cultures
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
MBT Sepsityper Kit US IVDenable可快速、特異地檢測許多菌血症引起的膿毒症病例，以協助傳染病專家做出潛在的救命決策直接從陽性血培養(PBC)中鑑定MALDI Biotyper®(MBT)，結果產生時間(TTR)短於30分鐘美國FDA於12月底獲得批准，用於MALDI Biotyper CA System的診斷使用，擁有425個生物庫，涵蓋革蘭氏陽性和革蘭氏陰性細菌，
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.
布魯克公司納斯達克股票代碼：BRKR)今天宣佈獲得美國FDA批准，並在美國推出MBT Sepsityper Kit US IVD，用於對MALDI Biotyper CASystem陽性血培養中超過425種微生物進行快速微生物鑑定。
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Figure 1: Ike Northern, Director of Infectious Disease Testing and Immunology, CompuNet Clinical Laboratory (Photo: Business Wire)
圖1：CompuNet臨牀實驗室傳染病檢測和免疫學主任艾克·諾斯(圖片來源：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.”
Bruker Daltonics微生物學和診斷部執行副總裁Wolfgang Pusch博士説：“與定向PCR檢測相比，在疑似細菌或真菌膿毒症病例中，可以從陽性血培養中快速鑑定出的微生物數量增加了一個數量級。這可能使MBT Sepsityper Kit US IVDa成為臨牀微生物學幾乎通用、快速的膿毒症識別解決方案。我們預計，這種負擔得起的快速檢測方法將使大量患者受益，因為它的成本只有昂貴的綜合症面板的一小部分，物種覆蓋範圍有限。更快的識別可以幫助傳染病醫生和藥劑師將膿毒症患者轉換為適當的抗生素或抗真菌藥物，以適應當地或醫院的感染模式，這將降低成本，延長重症監護病房的住院時間，並可以挽救生命。“
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.
MBT分離試劑盒(美國IVDenyper)能夠快速鑑定陽性血培養瓶中的許多微生物。收集的微生物經過處理，然後使用FDA清理的MALDI Biotyper CASystem進行鑑定，參考文庫涵蓋425種不同的革蘭氏陰性和革蘭氏陽性細菌種類和組，以及酵母菌，包括金黃色念珠菌(Candida Auris)，一種導致醫院獲得性念珠菌病的新病原體。
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.
MBT Sepsityper Kit US IVDWorkflow從血培養瓶陽性警報到身份識別通常只需不到30分鐘。與額外的瓊脂平板培養相比，它可以為許多鑑定節省長達24小時的結果時間(TTR)，在瓊脂平板培養後進一步節省8-12小時的生化鑑定時間。MBT試劑盒美國試管工作流程不檢測耐藥性或抗生素敏感性。一旦血液培養系統檢測到微生物生長，它就能快速識別微生物種類。
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.” (*)
俄亥俄州代頓市CompuNet臨牀實驗室傳染病檢測和免疫學主任艾克·諾斯先生解釋説：“我認為很多實驗室都意識到他們需要使用MALDI-TOF MS技術進行微生物鑑定。許多人在認識到長期的耐心和成本效益後，現在正在進行這項投資。MBT Sepsityper Kit US IVD將是許多臨牀微生物學實驗室的下一步。目前許多公司都在使用多重PCR檢測，但一旦有了MALDI生物分型儀器，使用MBT Sepsityper US IVD進行快速鑑定比使用PCR綜合徵面板更具成本效益。“(*)
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.
由於膿毒症和感染性休克的高死亡率和發病率，來自陽性血培養的快速檢測越來越受到臨牀微生物界的關注。據估計，膿毒症每年影響全球3000萬患者，其中許多人死亡或遭受永久性健康問題。通過迅速開始適當的抗生素治療(http://www.worldsepsisday.org)可以提高存活率。MBT Sepsityper US IVD是為與Bruker的美國FDA批准的MALDI Biotyper CA系統配合使用而開發的，旨在簡化和加快直接從膿毒症患者的陽性血培養中鑑定微生物。
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.” (*)
印第安納州哈蒙德阿爾維諾實驗室的醫學主任伊麗莎白·C·謝倫博士評論説：“快速(MBT)Sepsityper鑑定已經成為我們病人護理的重要工具。特別是在危重患者中，改善的週轉時間允許針對疾病的治療，從而節省衞生保健資源，最重要的是，改善患者的預後。“(*)
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.
目前，指南呼籲醫生迅速使用廣譜抗生素治療膿毒症患者，目標是一旦確定了感染微生物和/或確定了任何抗生素耐藥性，就切換到更有針對性的治療方法。MBT分離試劑盒US IVD可以通過提供快速的微生物鑑定來改進這一過程，以幫助臨牀微生物學家、治療醫生和患者。
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.” (*)
俄亥俄州代頓市邁阿密山谷醫院傳染病科主任史蒂文·D·伯德特博士補充説：“MBT Sepsityperkit數據使我們能夠根據我們當地的抗生素圖譜調整抗生素治療。有時，這使我們能夠縮小或停止某些抗生素治療，而在其他情況下，它使我們能夠在等待敏感性數據之前擴大抗生素覆蓋面。它已經成為我們抗菌管理團隊的重要工具。“(*)
* 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.
*所有引用的早期採用者在FDA批准MBT Sepsityper US IVD之前，都已經自我驗證了MBT SepsityperKit的僅供研究使用(RUO)版本。
About the BrukerMALDI Biotyper®(MBT) Platform
關於布魯克MALDI Biotyper®(MBT)平台
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).
MALDI Biotyper®可實現細菌、酵母和真菌的分子鑑定。利用高通量MALDI-TOF質譜的蛋白質組指紋圖譜，可以可靠、快速地實現微生物的分類和鑑定。MALDI Biotyperper使用基於細菌菌株特定蛋白質組指紋的分子方法。許多已發表的研究強調了更高的準確性和更低的成本，以及通常要快得多的結果時間(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.
各種MALDI生物系統的應用包括臨牀常規微生物鑑定、環境和藥物分析、分類學研究、食品和消費品安全和質量控制以及海洋微生物學。在許多歐洲和國際實驗室，由於該系統的準確性、速度、種類覆蓋面廣、易用性和成本效益，MALDI Biotyper在過去幾年中已經取代了傳統的生化測試來進行細菌鑑定。傳統的生化技術檢測微生物的不同代謝特性，可能需要幾個小時甚至幾天的時間才能完成，而且往往缺乏特異性。
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.
堅固的MALDI Biotyper只需要最少的樣品準備，且耗材成本低。MALDI Biotyper系列產品有僅供研究使用(RUO)版本，如美國FDA批准的MALDI Biotyper CA系統，或根據歐盟指令EC/98/79的IVD-CE版本。MALDI Biotyper在許多其他國家也有醫療設備註冊。
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.
ROO版本的MALDI Biotyper軟件允許進行精選的、高價值的抗菌素耐藥性測試。CE-IVDMBTSTAR®-CEPAKIT現在可以對頭孢菌素進行快速、有效的抗生素耐藥性檢測，CE-IVDMBT STAR-CABAKIT用於快速檢測碳青黴烯類抗生素耐藥性。
About Bruker Corporation(Nasdaq: BRKR)
布魯克公司簡介(納斯達克市場代碼：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 .
布魯克正在幫助科學家取得突破性的發現，並開發提高人類生活質量的新應用程序。布魯克的高性能科學儀器和高價值的分析和診斷解決方案使科學家能夠在分子、細胞和微觀水平上探索生命和材料。通過與我們的客户密切合作，布魯克正在推動生命科學分子研究、應用和製藥應用、顯微鏡和納米分析、工業應用以及細胞生物學、臨牀前成像、臨牀表型組學和蛋白質組學研究以及臨牀微生物學等領域的創新、提高生產率和客户的成功。欲瞭解更多信息，請訪問：www.bruker.com。
譯文內容由第三人軟體翻譯。