BD GeneOhm™ Cdiff Assay
The BD GeneOhm™ Cdiff assay is a qualitative in vitro diagnostic test for the rapid detection of C. difficile toxin B gene (tcdB) in human liquid or soft stool specimens from patients suspected of having Clostridium difficile infection (CDI). The test is based on real-time PCR and is intended for use as an aid in diagnosis of CDI. The BD GeneOhm™ Cdiff assay is the first diagnostic method to combine speed, sensitivity and specificity in a single method and provides definitive results that can be trusted for the detection of the C. difficile toxin B gene (tcdB) direct from patient samples. Quickly reaching a definitive diagnosis can ensure that CDI patients get the proper treatment without delay.1 CDI patients can be placed in isolation sooner to help reduce transmission and prevent outbreaks.1,2 Definitive results may help reduce inappropriate antimicrobial use in negative patients, which is consistent with antimicrobial stewardship guidelines.3
CDI: Increasing Problem for Healthcare Institutions
There are an estimated 500,000 cases of CDI per year. In 2005, the number of deaths in U.S. hospitalized patients exceeded 28,000 and 9.5% of patients with CDI died during their hospital stay.7 The financial and clinical burden of diarrhea due to toxigenic C. difficile is significant, with estimated hospital costs in excess of $1 billion annually.8 The epidemiology of CDI has been changing with increases in both disease incidence and severity. Patients with CDI had an increased length of stay in the hospital of nearly three fold and increased mortality in the hospital of approximately 4.5 fold.4 Transmission to patients occurs primarily via the hands of healthcare personnel or from contact with a contaminated environment.
Diagnosis of CDI
Diagnosis of CDI also impacts infection control and antimicrobial stewardship programs. Preemptive isolation of patients based on clinical suspicion (i.e. diarrhea) leads to isolation of patients who do not have CDI. Since physicians may not trust a negative EIA result, these patients may remain in isolation unnecessarily. Institutions that isolate only laboratory-confirmed cases of CDI may be missing positive patients (due to low sensitivity of current EIA test methods) that should be isolated. Lack of trust in negative results can also lead to empiric treatment being continued despite negative test results, and therefore overuse of antimicrobials.
Improving Patient Management
The BD GeneOhm™ Cdiff assay10 is a real-time PCR method for the rapid detection of toxin B gene (tcdB) direct from stool samples. It is more sensitive than cytotoxicity and can be performed in the same time frame as an immunoassay, which can help physicians quickly reach a definitive diagnosis with one rapid, same-day test result. Use of this new PCR method may help avoid repeat testing, multi-method algorithms and complicated reporting of results.
Definitive diagnosis of CDI may eliminate delays in the treatment of infected patients aimed at reducing the potentially severe outcomes of CDI.11 CDI-confirmed patients may be placed in isolation sooner to reduce transmission and prevent outbreaks of CDI.12 Definitively ruling out CDI can help avoid empiric treatment and unnecessary exposure to antibiotics in negative patients. This allows the physician to focus on other causes of patient symptoms and avoid unnecessary isolation of negative patients.
Let us show you how BD GeneOhm™ Cdiff can help improve diagnosis of CDI in your facility.