IVD MALDI Sepsityper workflow typically reduces Time-to-Result (TTR)
for sepsis by 24 to 36 hours for over 2,000 bacterial and over 200 yeast
species, while retaining all the advantages of blood cultures
COPENHAGEN, Denmark--(BUSINESS WIRE)--
At the 25th European Congress of Clinical Microbiology and Infectious
Diseases (ECCMID), Bruker announced the introduction of the new IVD
MALDI SepsityperTM kit and workflow with standard
operating procedures for the rapid identification of microorganisms from
positive blood culture bottles. The IVD kit is now labeled according to
the European IVD directive EC/98/79, and is developed for use with the IVD
MALDI Biotyper (IVD MBT) system for rapid MALDI-TOF mass
spectrometry-based microbial identification.
The IVD MALDI Sepsityper kit enables a rapid and easy isolation
and identification of microorganisms within minutes from positive blood
culture bottles. Harvested microorganisms are processed and then
identified using the IVD MALDI Biotyper. The identification assay
from positive blood cultures is applicable to Gram-negative and
Gram-positive bacteria, as well as to yeast. The IVD MALDI Biotyper
reference library covers more than 2,000 different bacteria species and
approximately 200 species of yeasts, including candida. This workflow is
recommended and optimized for blood culture bottles without any charcoal
supplements.
Overall, the IVD MALDI Sepsityper workflow
takes approximately 30 minutes after gram-staining and extraction from a
positive blood culture bottle to identification. It saves the day
normally required for additional agar plate culturing, and it can also
save an additional 8-12 hours, when compared to traditional biochemical
identification after agar plate culturing.
Sepsis is a life-threatening condition with high mortality rates.
Published studies have shown that each hour of delay in initiating
effective antibiotic therapy can increase mortality significantly. Due
to this high risk, and based on current sepsis guidelines, therapy is
typically initiated using broad-spectrum antibiotics to maximize the
probability of antibiotic coverage of the potential pathogen, with the
goal of either de-escalating therapy to a more narrow antibiotic, or to
switch antibiotic or antifungal therapy, based on laboratory findings.
The IVD MALDI Sepsityper workflow reduces the turnaround time
provided by traditional workflows by typically 24 to 36 hours after a
blood culture bottle becomes positive. The faster results provided by
the IVD MALDI Sepsityper workflow aid the clinician in the
management of blood stream infections. These earlier identification
results, combined with antibiotic stewardship programs, can reduce
healthcare costs substantially, and can improve patient outcomes, while
also assisting in the fight against antibiotic resistance via reductions
in the use of ineffective or expensive antibiotics. In contrast to pure
nucleic acid amplification test (NAATs), blood cultures do not amplify
biologically non-active DNA or cells, but only the most active and
relevant microbial species. Moreover, the IVD MALDI Sepsityper
workflow is untargeted and offers very broad microbial coverage of
gram-negative and gram-positive bacterial species, as well as clinically
relevant yeast species, including candida.
Dr. Cassie Pope, Consultant Clinical Scientist from St. George’s
Hospital in London, UK, said: “The introduction of the Bruker MALDI
Sepsityper kit into our workflow has proved to be a decision that we
are very pleased with, and that has resulted in clear benefits to the
laboratory and our users. We implemented it for the identification of
organisms in all blood cultures that have flagged as positive in the
morning. This has reduced our time to identification by 24 hours, and
allows us to provide a better service, and promotes timely prescription
of appropriate narrow spectrum antimicrobials. This is valued by
clinicians and they are now used to the improved service and earlier
identification information. Our scientific staff enjoys using the kit,
as it is easy to perform and provides identifications that they have
confidence in, typically within 30 minutes.”
Dr. Nils Morgenthaler, Vice President for Medical Affairs for the Bruker
Daltonics Division, added: “We and our collaborators now have several
years of experience with the research-use-only (RUO) MALDI Sepsityper
workflow, and the feedback from our customers and collaborators has been
very positive. So far, 21 peer reviewed scientific publications have
evaluated this approach, in which the RUO MALDI Sepsityper
workflow has been shown to provide approximately 80% correct
identification at the species level, with the remaining 20% mostly
unidentified, and with essentially no relevant misidentifications at the
genus level. With further recent improvements and expansion in the IVD
MALDI Biotyper reference library, this already excellent
identification performance directly from blood culture is expected to
improve even further. The recent CE-labeling of the kit underlines
Bruker´s strategy to provide more and more workflows for clinical
routine use on the IVD MALDI Biotyper platform. We believe that
the IVD MALDI Sepsityper kit and workflow has the potential to
rapidly become the new gold standard in microorganism identification in
clinical microbiology directly out of positive blood cultures, due to
its very short TTR and broad bacteria and yeast species coverage.”
About the Bruker MALDI Biotyper Platform
The MALDI Biotyper family of systems enables molecular identification,
and taxonomical classification or dereplication of microorganisms like
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 and published studies have
highlighted the greater accuracy and lower cost offered, as well as the
typically much faster time-to-result (TTR).
Applications of the 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 seven years
due to the accuracy, speed, extensive species coverage, ease of use and
cost effectiveness of the system. Classical 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 method 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 allow selected high-value antimicrobial resistance tests in
translational research.
ABOUT BRUKER CORPORATION (NASDAQ: BRKR)
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In close cooperation with our customers, Bruker is enabling innovation,
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industrial applications, as well as in cell biology, preclinical
imaging, clinical research, microbiology and molecular diagnostics. For
more information, please visit: http://www.bruker.com.
Source: Bruker Corporation