The rate of CDI in our institution between April 2011 and March 2012 was 32.2 cases per 100,000 occupied bed days (OBD). This compares to a national rate of 61.9 cases per 100,000 OBD for the same 10058-F4 mouse period. The UK does not define technical criteria for assessing the suitability of POCT; however, there are local guidelines which are overseen by a Point of Care Committee
in our hospital [18]. The study was conducted between March 2011 and January 2013 (22 months) in two settings; three adjacent older persons’ wards comprising a total of 85 beds, and two adjacent ICUs comprising a total of 30 beds. Comparator wards, consisting of one older persons’ ward and one ICU, had access only to laboratory-based testing and were used to compare study wards to investigate potential clinical utility. Members of staff were asked to test any patient with clinically significant diarrhea for CDI using the POCT (GeneXpert®); the residual sample was then tested in the centralized laboratory. The GeneXpert® system (Cepheid, Sunnyvale, California, USA) is an automated,
disposable cartridge based, real-time PCR assay which detects the genes for toxin B (tcdB), binary toxin (cdt) and a point mutation associated with PCR ribotype 027. A positive for the toxin B target indicates that toxigenic C. difficile has been detected; the two other targets provide information about the presence of presumptive ribotype 027. Two GeneXpert® systems were placed in the utility rooms of the three adjacent older persons’ wards. The ICU has its own co-located satellite laboratory, capable of performing a range of near-patient tests, into which PF01367338 a GeneXpert® system was placed. The residual stool sample was sent to the centralized laboratory for testing in parallel using a two-step algorithm [19] which comprised GDH (GDH Chek-60, TechLab, Blacksburg, Virginia, USA), with PCR (GeneXpert®) as a confirmatory step for positives. Results from both testing methods
together with turnaround times (from point of sample requesting to availability of result) were compared using the same sample. Compliance with Ethics Guidelines All procedures followed were in accordance with the ethical standards of the responsible committee IKBKE on human experimentation (London City and East Research Ethics Committee) and with the Helsinki Declaration of 1975, as revised in 2000 and 2008. Informed consent was obtained from all patients for being included in the study. Staff Training Nurses, healthcare assistants (older persons’ wards) and laboratory technicians (ICUs) were trained to use the POCT system by a research nurse. This generally took around 1 h and was done in small groups. Training consisted of a demonstration followed by direct observation of each staff member to ensure competence. Competent staff members were PCI-32765 solubility dmso provided with a password to operate the GeneXpert® system. Additional training was provided to those requiring it.