Abbott’s m2000 Menu Expands with FDA-Cleared Test for C. <i>difficile</i>

Abbott’s m2000 menu is rapidly expanding as it recently added another U.S. Food and Drug Administration (FDA)-cleared test for the detection of toxigenic Clostridium difficile (C. difficile), a common and serious bacterial infection. The new test, developed and manufactured by IntelligentMDx (IMDx) of Waltham, Mass., offers an accurate way to aid in the diagnosis of C.difficile-associated disease and to facilitate hospital infection control.

Toxigenic C.difficile can cause inflammation of the colon or colitis and is responsible for more than 14,000 deaths and 300,000 hospitalizations a year.¹ Infection is spread by the fecal-oral route and most often occurs in health-care settings.¹ Most non-severe C. difficile infections are resolved after 10-14 days of antibiotic therapy.

Rapid detection may prevent severe and widespread outbreaks and enable hospital personnel to identify and isolate infected patients. Molecular testing is becoming more standardized in the infectious disease laboratory because of its ability to accurately identify, characterize and quantify pathogens responsible for human diseases.

The IMDx C.difficile for Abbott m2000 test is a polymerase chain reaction (PCR) test for the qualitative detection of nucleic acids encoding toxigenic C.difficile toxin A and B genes. It is performed on Abbott’s m2000 fully automated molecular diagnostics system. With the addition of the C.difficile test in the U.S., the m2000 system now offers eight FDA-approved or cleared infectious disease assays as part of its broad menu.

1 Vital signs: Preventing Clostridium difficile Infections http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6109a3.htm. Accessed, November, 2013