Microbial Identification for Clinical Laboratories (US-IVD)

MBT Sepsityper® Kit US IVD

Highlights

MBT Sepsityper® Kit US IVD

Sepsis is a life-threatening condition that reportedly affects more than 30 million people worldwide each year. Early identification of the causative microorganism significantly improves patient outcomes in terms of morbidity and mortality and has a positive impact on the healthcare economy. Matrix-Assisted Laser Desorption/Ionization Time-Of-Flight mass spectrometry (MALDI-TOF MS) can reduce microorganism identification by up to 48 hours compared to traditional microbiology methods.

A complete solution for ease of implementation

Bruker’s MBT Sepsityper® Kit US IVD utilizes the Bruker MALDI Biotyper® CA System for the identification of microorganisms directly from positive blood culture.

The integration of the MBT Sepsityper® workflow into the MALDI Biotyper® CA System software is easy and efficient.

The identification of a standard sample and a MBT Sepsityper® sample can be combined in one MALDI Biotyper® CA System run and will be clearly differentiated in the final report.

The entire FDA cleared reference library of 488 microorganisms is used for the final identification for both sample types.

MBT Sepsityper® Kit US IVD for rapid microbial identification from positive blood cultures

  • Microbial identification directly from positive blood cultures within 15-20 minutes, with less than 10 minutes hands-on time per sample
  • Cleared for use on the MALDI Biotyper® CA System using the full library covering 488 organisms, being gram-positive bacteria, gram-negative bacteria and yeasts, including Candida auris
  • Provides accurate species level identification available up to 48 hours earlier than traditional methods, improving patient care and economic benefits

“Rapid Sepsityper identification has been instrumental in terms of 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.”

Dr. Elisabeth C. Shearon, Medical Director at Alverno Laboratories, Hammond IN

“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 cost benefits. The MBT Sepsityper® Kit US IVD will be the next step for a lot of clinical microbiology laboratories. Many are currently using multiplex PCR tests but once you have the MALDI Biotyper® instrument, it’s more cost-effective to use the MBT Sepsityper® Kit US IVD than large PCR panels.”

Ike Northern, CompuNet Clinical Laboratory, Director of Infectious Disease Testing and Immunology, Dayton, OH

“The MBT Sepsityper® Kit 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.”

Dr. Steven D. Burdette, Medical Director, Antimicrobial Stewardship Miami Valley Hospital and Premier Health, Dayton OH

All three customers performed in house LDT validation on the RUO version of the Sepsityper kit.

Eigenschaften

 

Only for sale in the USA and Puerto Rico.

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As of May 2021, Bruker Daltonik GmbH is now Bruker Daltonics GmbH & Co. KG.