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HAI

Identification of »hospital acquired infections« (nosocomial pathogens)

MRSA (methicillin-resistent Staphylococcus aureus) but also other pathogens e.g. Acinetobacter baumanii pose serious health threats. Some experts even worry that in the future putatively trivial infections might become untreatable just like in the pre-antibiotics era (see also: »The Antibiotic Apocalypse«).

This scenario can only be prevented by antibiotic stewardship and very targeted use of antibiotics.

A prerequisite is the early detection of resistant pathogens in order to implement all necessary measures to prevent the spread of this germs.

The early detection is the primary objective of the Genspeed® HAI test portfolio. Genspeed® assays can detect nosocomial pathogens in less than 100 minutes. Thus, the Genspeed® method is much faster than the conventional microbiological method which takes 24 – 72 hours.

The key advantages of Genspeed® HAI products at a glance:

  • Small footprint, low initial investment
  • Targeted identification of nosocomial pathogens and their resistances
  • Fast and easy analysis of individual samples
  • Ready-to-use test kits
  • Automation for reduction of manual steps
  • Clear and concise reporting
  • Detailed results analysis as well as statistical overview
  • Integrated process controls
  • Turn-around time ≤ 100 min

The Genspeed® HAI portfolio:

Product folder (PDF download) ›

The Genspeed® comprises the following test kits:

Customer Testimonials

»Integration of the system with our lab workflow was very easy. Genspeed® combines accurate results with a high degree of safety.«
»The robustness and stability of Genspeed® is very satisfying with more than 300 analyses performed last year.«
Monika Vedder, Head of Laboratory, Main-Spessart Clinic, Gesundheitspark Marktheidenfeld, Germany
»The Genspeed® assay portfolio covers the most relevant pathogens in nosocomial infections.«
»Genspeed® assays deliver fast results and contamination is not an issue at all.«
Professor Efthymia Petinaki, President of Department of Microbiology, Medical School of General University Hospital of Larissa, Greece

MRSA

mecA and mecC detection in less than 100 min*

* Time can vary with validated PCR-cycler used.

Ablaufdiagramm MRSA

Genspeed® MRSA is a diagnostic tool for the qualitative detection of methicillin resistant Staphylococcus aureus (MRSA) in human nasal and pharyngeal smears, inguinal swabs or bacterial culture.

S. aureus is recognized worldwide as the most significant cause of nosocomial infections. Genspeed® MRSA was developed as a time and cost saving rapid test for low throughput testing applications in hospitals and laboratories.

The main advantage of the product lies in the acceleration of the analysis, providing reliable results with a short turnaround time. An efficient MRSA screening policy not only ensures the well-being of your patients but is also an important economic consideration. The early detection is key to prevent MRSA-associated complications, prolonged hospital stays and the resulting additional expenses of 1,600.- EUR per patient per day.

Conventional culture for MRSA analysis takes up to 48 hours, leading to additional care and treatment costs for the necessary quarantine days. Other molecular biological systems have been developed for high throughput application. Those systems require sample batching in order to be economically efficient. Consequently, here are even more delays to obtain the results for an individual patient sample.

Das Genspeed® MRSA is particulary suitable for low throughput applications and allows mecA and mecC detection in less than 100 min. The resistance behaviour to methicillin is encoded by the Staphylococcus Cassette Chromosome mec (SCCmec).

So-called »Empty Cassette Variants« are a problem for many MRSA test systems on the market. These are S. aureus strains whose gene cassette does not contain the resistance gene mecA (deletion) therefore they are sensitive to methicillin (treatment with antibiotics possible). Test systems which target the cassette as an entity, disregard the mecA gene and yield false positive results.

Moreover, in 2011 the new gene variant mecC was discovered in England and has since then been detected in six more countries: DE, DK, FR, IE, NL, PT. Although the examined strains show phenotypical methicillin resistance, it could not be detected with PCR tests currently on the market.

Genspeed® MRSA detects both methicillin resistance genes – mecA and mecC.

For further information please download our MRSA folder: MRSA-Folder (PDF) ›

Genspeed MRSA papers:

  • H. Kerschner, E.M. Harrison, R. Hartl, M.A. Holmes, and P. Apfalter: »First report of mecC MRSA in human samples from Austria: molecular characteristics and clinical data«. New Microbes & New Infections, Vol. 3 (January 2015), No. C
  • Andreas Petersen, Alexandra Medina, Anders Rhod Larsen: »Ability of the Genspeed® MRSA test kit to detect the novel mecA homologue mecC in Staphylococcus aureus«, http://onlinelibrary.wiley.com/doi/10.1111/apm.12376/pdf

C.diff OneStep

All important parameters in one assay

Ablaufdiagramm C.diff OneStep

Genspeed® C.diff OneStep s a rapid diagnostic test for the qualitative detection of toxigenic Clostridium difficile in stool samples using the Genspeed® technology.

Genspeed® C.diff OneStep combines ease of use, generation of comprehensive high quality results with a fast time to result featuring:

  • OneStep diagnostic algorithm
  • One single multiplexed test for four Clostridium-specific genes
  • High specificity and sensitivity
  • Fast turnaround time – results in under 100 min*
  • Detection of predictive marker for recurring C. difficile colitis
  • Attractive cost-benefit ratio

Clostridium difficile

Clostridium difficile is an anaerobic gram positive, rodshaped, spore-building bacterium. C. difficile infection (CDI) is the most common healthcare-associated infection, causing antibiotic-associated diarrhoea (AAD) that may lead to pseudomembranous colitis and even death. CDI has an enormous impact on healthcare systems worldwide and it is estimated that C. difficile-associated diseases cause additional costs of up to EUR 3 billion per year in Europe1. It is believed that CDI causes 14.000 deaths per year in the United States of America alone.

C. difficile spores are particularly resistant to heat, drought and disinfectants. Any C. difficile carrier can shed these spores and thus contribute to the spread of the infection. C. difficile strains show varying pathogenicity through different levels or combinations of

  • Toxin A (enterotoxin, also described as TcdA)
  • Toxin B (cytotoxin, also described as TcdB)
  • Binary Toxin (also described as CdtA/B; considered to be a virulence factor, associated with recurrent CDI).

However, the detection of these pathogenic C. difficile strains is hampered by the fact that there are toxin and non-toxin producing C. difficile strains, both of which are producing glutamate dehydrogenase (GDH).

Genspeed® C.diff OneStep integrates the two-step method into a single assay and offers fast, sensitive and conclusive results.

  • One-Step assay
  • One assay principle
  • Better Lab-to-Lab comparability of test results

For further information please download our C.diff OneStep folder: C.diff OneStep folder (PDF) ›

Superbug CR

Tracking down carbapenem-resistance

Genspeed® Superbug CR is a rapid diagnostic test for the qualitative detection of the most relevant bacterial carbapenemase genes in stool and rectal swab samples using the Genspeed® technology.

The Genspeed® Superbug CR test combines ease of use with the generation of comprehensive high quality results featuring:

  • Simple preanalytics and integrated controls
  • One single multiplexed test for the detection of more than 70 carbapenemase-variants
  • High specificity and sensitivity
  • Short turnaround time – results in under 100 min*
  • Attractive cost-benefit ratio

Carbapenem-Resistance

Due to the soaring prevalence of antibiotic resistant bacteria in health-care facilities, carbapenems very often represent the last remaining treatment option for numerous life-threatening infections.

The epidemiology of carbapenem-inactivating enzymes, the so-called carbapenemases, has already been well documented. In Europe, current trends and observed prevalence data of carbapenem-resistance have been summarized since 2005 by the European »Antimicrobial Resistance Surveillance Network« (EARS-Net). Data from 2014 show prevalence rates for carbapenem-resistant K. pneumoniae isolates in Greece, Romania and Italy of 62.3 %, 31.5 % and 32.9 %, respectively. A recent health report from the WHO describes similar prevalence values in the European Region (n = 31 countries) of up to 68 % and in the eastern Mediterranean region (n = 4 countries)

Conventional methods to detect Carpabenem-resistant bacteria -
a question of experience and interpretation

Microbiological culture methods to characterize antibiotic resistance of bacterial isolates require incubation periods of at least 24 to 48 hours. The obtained phenotypes have to evaluated on the basis of subjective parameters (for example, measurements for the determination of the minimum inhibitory concentrations (MIC), color changes, ...). The experience of the person performing the tests is critical and can lead to increased variations during assessment of the results.

Genspeed® Superbug CR offers fast, specific and conclusive results:

  • One-Step assay
  • Objective, reproducible reports
  • Better lab-to-lab comparability of test results

For further information please download our Superbug CR Folder: Superbug CR folder (PDF) ›

VanABC plus

Complete information on Vancomycin-resistance

Genspeed® VanABC plus is a rapid diagnostic test for the qualitative detection of genes associated with vancomycin-resistance in bacteria obtained from rectal swabs, stool or bacterial culture.

Genspeed® VanABC plusplus combines ease of use with the generation of comprehensive high quality results featuring:

  • Detection of transmissible and non-transmissible vancomycin resistance genes
  • Single-tube multiplex assay for resistance and marker genes
  • High specificity and sensitivity
  • Fast turnaround time – results in under 100 min*
  • Attractive cost-benefit ratio

Vancomycin resistant bacteria

Vancomycin-resistance is most often encountered in bacteria belonging to the genus enterococcus hence their name vancomycin resistant enterococci (VRE). Most enterococcal infections aredue to E. faecalis and E. faecium. While in the US 75 % of all clinical E. faecium isolates are vancomycin resistant, the resistance rates within Europe vary between 1 % and 31 %.

There are two main types of vancomycin-resistance in enterococci. The first type is intrinsic resistance typically permitted by the presence of vanC genes in certain enterococcal sepcies (E. gallinarum, E. casseliflavus). The second type of vancomycin-resistance is acquired resistance. Enterococci can become resistant to vancomycin by acquisition of certain gene clusters. Those vanA and vanB resistance phenotypes are most commonly seen in E. faecium and E. faecalis, but may also be transferred to other bacterial species such as Staphylococcus aureus.

Conventional methods to detect Vancomycin resistant bacteria–
a question of experience and interpretation

The results of conventional microbiology testing may be influenced by the experience of the personnel in reading inhibition zones and interpreting the results2. Susceptibility tests on enterococci need an incubation time of at least 24 h to ensure the visibility of resistant colonies. While vanA phenotypes are more readily identifed, vanB-type VRE may be difficult to detect, due to the inducible mechanism of resistance and the variable levels of vancomycinresistance expressed.

Genspeed® VanABC plus offers fast, specific and conclusive results:

  • One-Step assay
  • Objective, reproducible reports
  • Better lab-to-lab comparability of test results

For further information please download our VanABC plus folder: VanABC plus folder (PDF) ›