Bruker Corporation has announced US FDA clearance and the US launch of the MBT Sepsityper Kit US IVD for rapid microbial identification of more than 425 microorganisms from positive blood cultures on the MALDI Biotyper CA System.

The MBT Sepsityper Kit US IVD enables the rapid identification of many microorganisms from positive blood culture bottles. Harvested microorganisms are processed and then identified using the FDA-cleared MALDI Biotyper CA System, with a reference library that covers 425 different gram-negative and gram-positive bacterial species and groups, as well as yeasts, including Candida auris, an emerging pathogen for hospital-acquired candidiasis.

The MBT Sepsityper Kit US IVD workflow 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.

The MBT Sepsityper Kit US IVD workflow 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. 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 is more cost-effective to use the MBT Sepsityper Kit US IVD for fast identification than PCR syndromic panels,” said Ike. (*) 

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 appropriate antibiotic therapy.

Developed for use with Bruker's U.S. FDA-cleared MALDI Biotyper CA System, the MBT Sepsityper Kit US IVD is intended to simplify and speed up identification of microorganisms directly from positive blood cultures of sepsis patients.

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. The MBT Sepsityper Kit US IVD can improve this process by providing rapid microbial identifications to help clinical microbiologists, treating physicians, and patients alike.

* All quoted early adopters have self-validated the research-use-only (RUO) version of the MBT Sepsityper kit prior to FDA-clearance of the MBT Sepsityper Kit US IVD.

Bruker MALDI Biotyper® (MBT) Platform
The MALDI 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.

The MALDI Biotyper uses 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 various MALDI Biotyper solutions 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, the MALDI Biotyper has 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 robust MALDI Biotyper requires minimal sample preparation and offers low consumables cost. The products of the MALDI Biotyper family are available in a research-use-only (RUO) version, as the U.S. FDA-cleared MALDI Biotyper CA System, or in an IVD-CE version according to EU directive EC/98/79. The MALDI Biotyper also has medical device registrations in numerous other countries.

RUO versions of the MALDI Biotyper software allow selected high-value antimicrobial resistance tests. The CE-IVD MBT STAR®-Cepha kit now allows rapid, functional antibiotic resistance testing against Cephalosporins, and the CE-IVD MBT STAR-Carba kit is for fast Carbapenem-resistance testing.