Microbial Identification for Clinical Laboratories (IVD-CE)

MBT STAR®-Cepha IVD Assay

Resistance detection towards 3rd generation cephalosporins within just one hour after a positive blood culture alert

Destaques

MBT STAR®-Cepha IVD Assay

To counteract the rise of multidrug-resistant (MDR) bacteria, Bruker is dedicated to developing new solutions to keep pace. The rapid identification and determination of resistance is vital for clinicians and physicians to provide their patients with the antibiotic that promises rapid, gentle and appropriate treatment, as quickly as possible.

Countering multi-drug resistance bacteria

The rate of resistance to 3rd generation cephalosporins – important drugs for the treatment of gram-negative bacteria – has been rising steadily in recent years, and is of great concern for global public health, particularly in healthcare settings. Cephalosporin resistance leaves limited treatment options for some of the world’s most pathogenic infections, placing an urgent need on rapid, accurate methods of resistance detection, as well as the development of new antibiotics.

The MBT STAR®-Cepha IVD Assay detects resistances towards 3rd generation cephalosporins within just one hour after a positive blood culture alert, by analyzing the activity of cephalosporinase enzymes produced by the bacteria. Newer technologies, such as Matrix-Assisted Laser Desorption/Ionization Time-Of-Flight mass spectrometry (MALDI-TOF MS), are now being used for specialized assays such as the MBT STAR®-Cepha IVD Assay to combat the MDR bacteria threat.

Características

Detecting cephalosporinase activity

Together with Bruker’s IVD-CE MALDI Biotyper® (MBT), the MBT STAR®-Cepha IVD Kit enables the detection of the characteristic enzymatic hydrolysis of the β-lactam ring of 3rd generation cephalosporin antibiotics. The level of hydrolysis is measured by acquisition of mass spectra in the typical mass range of the antibiotic. The assay allows detection of most actively expressed extended-spectrum beta-lactamases (ESBL) and AmpC β-lactamases in MDR gram-negative Enterobacterales:

ESBL:

  • e.g. plasmidic TEM, SHV and CTX-M

AmpC:

  • Chromosomal and plasmidic
  • Inducible or overexpressed resistance genes
  • e.g. AmpC, FOX, LAT, DHA and CMY.

Simple workflow, fast results

Starting from a positively flagged blood culture, processed by the rapid MBT Sepsityper® workflow, or a (sub)culture plate, results are typically available within 60 minutes.

For this purpose, bacteria are incubated with a benchmark 3rd generation cephalosporin antibiotic, conveniently provided in a microtiter plate contained in the kit.

After an assay incubation period of 30 minutes, aliquots are transferred onto a MALDI target plate, covered with dedicated MBT STAR® Matrix, and analyzed at the level of the antibiotic, using the IVD-CE MALDI Biotyper®.

The presence of cephalosporinase activity results in specific mass shifts of the antibiotic, evaluated by the dedicated MBT STAR®-BL IVD Software Module for MBT Compass IVD. Acquired mass spectrometric data are processed and the ratio of hydrolyzed to non-hydrolyzed cephalosporin antibiotic is calculated automatically and instantly in the background by the MBT STAR®-BL IVD Module. The user receives a final report including assay results interpretation, facilitated by means of simple color coding indicating the status of enzyme activity.

 

Please contact your local representative for availability in your country.

Not for sale in the USA.

Mais informações

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