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Orion GenRead C. difficile

Orion GenRead C. difficile is a molecular test intended for detection of toxigenic Clostridium difficile from faecal samples from patients suspected of having C. difficile infection (CDI).

Generally

Orion GenRead C. difficile is a ready-to-use kit which offers its users fast and accurate results. The test kit is used together with the Orion GenRead Instrument and is suitable for laboratories of various settings and sizes.

Performing the test requires neither special facilities nor expertise in molecular diagnostics. The simple test procedure includes only a few hands-on steps and can be performed directly from faeces.

An internal control DNA ensures reliable results by monitoring amplification success, reagent integrity and potential inhibitors. The amplification and detection of target DNA takes place in the Orion GenRead Instrument which is HIS/LIS connectable. 

The Orion GenRead system is based on SIBA technology, Orion Diagnostica’s proprietary isothermal nucleic acid amplification technique.

Orion GenRead C. difficile provides you with

Easy to use

  • Simple sample handling procedure
  • All-inclusive reagent kit with colour coded reagents 
  • Internal control integrated in each test tube

Fast results

  • Less than one hour test time is easy to fit into daily work
  • Sample ID’s can be added while the instrument measures
  • Strong positive results are shown already in 15 minutes

Flexible

  • Allows testing 1 - 12 samples at a time
  • Suitable for various laboratory settings
  • Fits easily into laboratory workflow and ambulatory testing

Reliable

  • Proven performance
  • Robust technology requires no special training 

Test results should never be used alone, without a complete clinical evaluation. 

Orion GenRead C. difficile is not registered in the USA. 

Technical data

Products available
Method

Isothermal nucleic acid amplification iNAT based on SIBA (Strand Invasion Based Amplification) technology

Sample type Faeces
Time to result Less than one hour
Reading of the result Instrument read
Storage 2 - 8 °C
Additionally needed

Orion GenRead Instrument

Registration Not registered in the USA
Registered trademark Orion GenRead is a registered trademark of Orion Diagnostica Oy.

About Clostridium difficile

Clostridium difficile is a Gram-positive bacterium that causes severe diarrhoea and other intestinal disease in elderly and patients whose microbiota has been destroyed after antimicrobial therapy. Disruption of the normal gut microbiota allows C. difficile to proliferate, causing a broad spectrum of clinical manifestations. These can range from asymptomatic carriage to diarrhoea of varying severity to fulminant and sometimes fatal pseudomembranous colitis.

The virulence of C. difficile is caused primarily by two exotoxins, clostridial toxins A and B. The toxins are encoded by their respective genes tcdA and tcdB, which are located, along with surrounding regulatory genes, on a 19.6-kilobase section of chromosomal DNA known as the pathogenicity locus (PaLoc).

C. difficile is a spore-forming bacterium that is easily transmitted among patients through the faecal-oral route by contaminated sources in the environment or the hands of healthcare personnel. It is the leading cause of healthcare-associated diarrhoea and is responsible for considerable patient morbidity and cost to the healthcare system.

Early and rapid identification of C. difficile infection is important for adequate treatment of the patient and initiation of infection control measures to prevent transmission.

Documents and materials

Marketing and sales materials

Orion GenRead Family Brochure (GB)

Orion GenRead C. difficile Sales Sheet (GB)

Orion GenRead C. difficile Brief Instructions (GB)

Orion GenRead C. difficile Infographic 1 (GB)

Orion GenRead C. difficile Poster EMMD 2015 (GB)

Orion GenRead C. difficile Poster ICDS 2015 (GB)

Orion GenRead C. difficile Poster ECCMID 2014 (GB)

Stories

C. difficile infection (CDI) and updates to C. difficile diagnostic guidelines

Clostridium difficile is the major cause of healthcare-associated infections (HAIs)

Scientific material

Orion GenRead and SIBA Publications (GB)

Hirvonen et al. 2016: http://rd.springer.com/article/10.1007/s10096-016-2860-0

Instructions for use

For informative use only. Kindly always refer to the latest package insert in the kit.

Orion GenRead C. difficile IFU (GB, DE, FR, NL)

Orion GenRead C. difficile IFU (FI, SE, DK, ES)

Orion GenRead C. difficile IFU (CZ, SK, PL, IT)

Safety Data Sheet

Orion GenRead C. difficile SDS (GB)

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