Simplexa™ C. difficile Universal Direct Kit

C. difficile

Clostridium difficile infections (CDI) are a leading cause

of hospital-acquired diarrhea in industrialized countries1

and recent studies suggest are under diagnosed in

Europe.2 This spore-forming bacterium is resistant

to common disinfectants3 and persists in humans

and numerous environmental reservoirs in healthcare

facilities and communities.

Incidence of CDI in Europe almost doubled from 2008 to

2013. Up to 40,000 cases may be missed each year, in large

part due to suboptimal testing. Furthermore, hypervirulent

ribotypes have become predominant,4 increasing the

burden on healthcare systems with extended patient bed

days, high readmission rates, and high mortality rates for

susceptible patients.5,6 However, countries with optimal CDI

diagnostics and policies have recently shown reduction in

their prevalence of these ribotypes.2

Toxin detection assays are subject to variation and suffer

from a lack of sensitivity, whilst toxigenic culture is

impractical.7 Simplexa™ C. difficile Universal Direct is your

flexible solution to help you effectively manage patient care.

Direct detection of C. difficileusing real-time PCR

Focus Diagnosticsis now operating asDiaSorin Molecular

Simplexa™ C. difficile Universal Direct Clinical Agreement

Simplexa™ C. difficile Universal Direct kit and the Integrated Cycler

• No extraction required – easy sample processing

• Targets the tcdB (toxin B) gene

• A qualitative real-time PCR assay for use on the Integrated Cycler

• Fast and scalable throughput – perform up to 94 patient samples per run

• Rapid and definitive assay – results available in about an hour after processing

Simplexa and the associated logo are all trademarks or registered trademarks of DiaSorin Molecular LLC in the U.S. and/or other countries. ©2016 DiaSorin Molecular LLC. All rights reserved.

The use of Scorpions® probes for human in vitro diagnostic purposes is covered by a license to DiaSorin Molecular LLC from QIAGEN Manchester, UK. Scorpions is a registered trademark of QIAGEN Manchester, UK.

Black Hole Quencher, CAL Fluor, Quasar dyes are trademarks of Biosearch Technologies, Inc. DiaSorin products incorporating the Black Hole Quencher, CAL Fluor, and Quasar dye technology are licensed and sold pursuant to an agreement with Biosearch Technologies, lnc., and these products are sold exclusively for clinical, diagnostic, or research and development purposes.

DiaSorin Molecular Cypress, California USA PH +1.562.240.6500 FX +1.562.240.6510

www.focusdx.com • www.diasorin.com

DXCDUD1216

REFERENCE PCR* NSimplexa™

% AGREEMENTPOSITIVE NEGATIVE

POSITIVE 110 109 199.1% (109/110)

95% CI:95-99.8%

NEGATIVE 79 7 7291.1% (72/79)

95% CI:82.8-95.6%*CE marked assay from BD.

Simplexa™ C. difficile Universal Direct

CATALOG NUMBER DESCRIPTION REACTIONS

MOL2975 CE FDA Simplexa™ C. difficile Universal Direct 100

Integrated Cycler

CATALOG NUMBER DESCRIPTION QUANTITY

MOL1001 CE FDAIntegrated Cycler, 110V, laptop computer, accessories box, and optional printer

1 each

MOL1011 CE FDAIntegrated Cycler, 220V, laptop computer, accessories box, and optional printer

1 each

References: 1. Crobach MJ, et al. European Society of Clinical Microbiology and infectious Disease (ESCMID): Data review and recommendation for diagnosing Clostridium difficile-infection (CDI). Clinical Microbiology and Infection. 2009;15:1053-1066. 2. Davies KA, et al. Underdiagnosis of Clostridium difficile across Europe: the European, multicentre, prospective, biannual, point-prevalence study of Clostridium difficile infection in hospitalised patients with diarrhoea (EUCLID). Lancet Infect Dis. 2014 Dec;14(12):1208-19. 3. Fawley WN, et al. Efficacy of hospital cleaning agents and germicides against epidemic Clostridium difficile strains. Infect Control Hosp Epidemiol. 2007 Aug;28(8):920-925. Epub 2007 Jun 15. 4. Davies KA, et al. Diversity of Clostridium difficile PCR ribotypes in Europe: results from the European, multicentre, prospective, biannual, point-prevalence study of Clostridium difficile infection in hospitalised patients with diarrhoea (EUCLID), 2012 and 2013. Euro Surveill. 2016;21(29):pii=30294. 5. Lessa FC, et al. Burden of Clostridium difficile infection in the United States. N Engl J Med. 2015;372:825-834. 6. Magalinis S, et al. An economic evaluation of Clostridium difficile infection management in an Italian hospital environment. Eur Rev Med Pharmacol Sci. 2012;16:2136-2141. 7. Cohen SH, et al. Clinical practice guidelines for Clostridium difficile infection in adults: 2010 update by the Society for Healthcare Epidemiology of America (SHEA) and the Infectious Diseases Society of America (IDSA). Infect Control Hosp Epidemiol. 2010 May;31(5):431-455.

Focus Diagnostics

is now operating as

DiaSorin Molecular