Simplexa™ C. Difficile Universal Direct Test Eliminates Extraction Step

The Simplexa™ C. difficile Universal Direct test on the 3M™ Integrated Cycler has now been made available in Europe. The new CE marked in vitro diagnostic Simplexa test enables fast, high volume lab testing, eliminating the traditional extraction step and allowing for processing of up to 94 patient specimens in about an hour.

Simplexa tests, running on the 3M™ Integrated Cycler, employ real-time polymerase chain reaction (RT-PCR) to qualitatively and quantitatively detect viruses, bacteria and other agents. The Simplexa C. difficile Universal Direct test is performed on liquid or unformed human stool samples and detects toxin producing strains of Clostridium difficile, including NAP1/B1/027.

'Our Simplexa C. difficile Universal Direct test will help physicians make a fast, reliable diagnosis of CDI,' says Dr. John Hurrell, General Manager at Focus Diagnostics. 'This is vital to treating patients and reducing the threat of transmission to other patients.'

Focus Diagnostics launched the Simplexa molecular product line in 2009 with a focus on influenza and respiratory syncytial virus. Since that time, the Simplexa product line has expanded to include Tests for detecting Flu A/B and Respiratory Syncytial virus, EBV, BK virus and Bordetella pertussis. Simplexa tests run on the 3M Integrated Cycler, a compact, portable testing platform that can provide results in as few as 60 minutes following sample extraction, as part of an exclusive worldwide agreement with 3M.