GENSPEED® C.diff OneStepOneStep ahead – The new molecular way of detecting C. difficile

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C.diff OneStep

GENSPEED® C.diff OneStepThe new molecular way of detecting C. difficile

C.difficile?One test -

4 targets

Sequential two-step methods are using different combinations of different test principles:

Sampling

Confirmatory toxin / Toxin testing(Toxin A and/or B, binary toxin)

Different Real-Time PCRand/or Antigen assays

GDH-AnalysisGDH ELISA(incl. GDH / Toxin A/B test)

2nd Sampling

The GENSPEED® C.diff OneStep alternative offers fast, specific and conclusive results due to its unique multi-parameter based identification algorithm:

Preanalytik Genspeed®SamplingGENSPEED®

C.diff OneStep Test(GDH + Toxin A/B and binary toxin)

GENSPEED® C.diff OneStep test systemAll important parameters in one assay

GENSPEED® C.diff OneStep is a rapid diagnostic test for the qua-litative 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 colitis3

• Attractive cost-benefit ratio

CLOSTRIDIUM DIFFICILEClostridium difficile is an anaerobic gram positive, rods-haped, spore-building bacterium. C. difficile infection (CDI) is the most common healthcare-associated infec-tion, 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 alone2.

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 combina-tions 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 dehy-

drogenase (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

The GENSPEED® C.diff OneStep test combines the detection of GDH, toxin A and B as well as the binary toxin in a single simple molecular diagnostic test.

* Time can vary with validated PCR-cycler used.

Simple preanalytics, ready-to-use reagents and sensitive, multiplex PCR for fast and accurate results. A ready-

to-use system with a short time to result.

Advantages of the GENSPEED® C.diff OneStep test system

SINGLE ASSAY ANALYSIS No need for a two-step method

High specificity and sensitivity, easy comparison of test results possible (lab-to-lab)

DETECTION OF GDH AND TOXIN GENESComplete information with a single test principle.

COST EFFICIENCYAttractive cost-benefit ratio including the GENSPEED® R2 Analyzer.

FAST AND ACCURATE RESULTSSaving time, money and allowing fast decisions.

PPV OF 100 %No false positives.

FAST TURNAROUND TIMEFour different C. difficile parameter, one test in under 100 minutes*.

DETECTION OF THE BINARY TOXINKey factor in predicting the recurrence of C. difficile colitis3

SIMPLE PRE-ANALYTICSNo DNA extraction.

DIFFERENTIAL DIAGNOSTICSBinary toxin can be indicative for the potential virulence of the C. difficile strain.

Study-data4

PPV 100 %

NPV 98,9 %

Specificity 95 %

Sensitivity 83,3 %

Prevalence 6 %

Simple pre-analytics included in the test kit is combined with ready-to-use reagents for fast and accurate test results. The amplified samples are transferred to the GENSPEED® C.diff OneStep test chip and are automatically read within 10 minutes.

TECHNICAL ADVANTAGES OF THE GENSPEED® R2 ANALYZER• Easy handling• Objective results• Optional interfacing with your LIMS*• Up to four devices can

be used in parallel

• Clear and comprehensive reporting• Integrated statistical analysis

* laboratory information management system

REFERENCES1 KuijperEJ, Cognard B, Tüll P et al. Emergence of Clostridium difficile- associated

disease in North America and Europe., Clin Microbiol Infect 2006; 12 Suppl 6:2-182 ANTIBIOTIC RESISTANCE THREATS in the United States, 2013, http://www.cdc.gov/

drugresistance/threat-report-20133 Stewart, David B.; Berg, Arthur; Hegarty, John (2013): Predicting recurrence of

C.difficile colitis using bacterial virulence factors: binary toxin is the key. In: J Gastrointest Surg 17 (1), S. 118-24; discussion 124-5, Predicting recurrence of C.difficile colitis using bacterial virulence factors: binary toxin is the key.

4 Clinical study data

Components of the GENSPEED® C.diff OneStep test system

THE GENSPEED® C.diff OneStep TEST CHIP• facilitates rapid testing by special

microfluidics for accelerated hybridization• contains DNA probes for:

• Toxin A• Toxin B• GDH• Binary Toxin

• three on-chip process controls:• hybridisation control• PCR control• negative control

THE GENSPEED® R2

In order to offer optimal ease of use, the analyzer features:

• power supply and control via USB• integrated microliter dispensing unit for automated injection

of reagents from an exchangeable cartridge (48 tests)• an integrated calibrator• an integrated barcode module for identifying the Test Chip• patented optoelectronics for highly sensitive detection

THE NOTEBOOK WITH INTEGRATED GENSPEED® REPORT SOFTWARE• controls the GENSPEED® R2

(up to 4 units in parallel)• offers intuitive user guidance

through test procedure• analyses measurement data• creates individualised reports• allows optional connection to the LIMS

THE PCR-CYCLER / ACCESSORIES

All GENSPEED® assays are validated for three different PCR-Cyclers (ask your local sales representative for more infor-mation)

• 2 fixed volume pipettes• 1 tube rack• 2 boxes filter tips

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For further information please visit our website www.genspeed-biotech.com

GENSPEED Biotech GmbHGewerbepark 2 · Gebäude B4261 Rainbach · AustriaE-Mail office@genspeed-biotech.com

Item No. Description Packaging

GSHW103EN* GENSPEED® Starter Package (GENSPEED® R2, PCR-Cycler, Notebook, Accessories) 1 pc.

GSHW001 GENSPEED® R2 Analyzer 1 pc.

GSTK102 GENSPEED® C.diff OneStep Test Kit (incl. Preanalytics Kit) 48 rxn.

* GSHW103EN contains peqSTAR Thermocycler (other cycler on request)

PCR• Ready-to use mastermix• Fast cycling program

RESULTSSoftware-generated report

ON CHIP ASSAY• Ready-to-use reagents• Interface-guided process

ARTICLE OVERVIEW GENSPEED® C.diff OneStep TEST SYSTEM

PRE-ANALYTICAL SAMPLE PREPARATION< 2 minutes