Rapid Diagnostic for C. difficile Eliminates Extraction Step

difficile universal direct test is performed on liquid or unformed human stool samples, and detects toxin-producing strains of C. difficile, including NAP1/B1/027. The new CE marked in vitro diagnostic (IVD) test enables fast, high volume lab testing, eliminating the traditional extraction step.

The C. difficile diagnostic is the first test from the Focus Diagnostics (Cypress CA, USA) Simplexa product line for the hospital-acquired infection (HAI) market. It was unveiled by Focus together with the CE marked Simplexa Epstein Barr (EBV) and BK Virus tests during the European Congress of Clinical Microbiology and Infectious Disease (ECCMID) Tradeshow, which took place May 7-10, 2011, in Milan (Italy). The three Simplexa tests are CE marked and available in Europe.

Simplexa tests are run on the 3M Integrated Cycler and employ real-time polymerase chain reaction (RT-PCR) to detect viruses, bacteria, and other agents qualitatively and quantitatively.

C. difficile infection (CDI) is a bacterial infection that generally affects patients over 65 in age, on prolonged use of broad-spectrum antibiotics, and those who have recently undergone gastrointestinal surgery or are immunocompromised. In major European Union (EU) countries, such as Belgium, Denmark, France, Germany, Italy, Netherlands, Spain and the United Kingdom, CDI is estimated to be responsible for 1.1 in 1,000 hospital admissions and is expected to double over the next four decades.

"Clostridium difficile is a common cause of antibiotic-associated diarrhea and an extremely important and serious hospital-acquired infection," said Jay M. Lieberman, MD, medical director for Quest Diagnostics (Madison, NJ, USA) and Focus Diagnostics. "C. difficile infections (CDI) range in severity from mild diarrhea to life-threatening pseudomembranous colitis, and result in significant suffering and deaths. Timely diagnosis is essential for clinicians when treating patients presenting with possible C. difficile disease." Focus Diagnostics is a wholly owned subsidiary of Quest Diagnostics.

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