Development of Serum and saliva immunoassay to Clostridium difficile
Research type
Research Study
Full title
Development of serum and saliva immunoassay to Clostridium difficile
IRAS ID
137289
Contact name
Tim Planche
Contact email
Research summary
Clostridium difficile infection (CDI) is usually healthcare associated, related to antibiotic use, and typically manifests as diarrhoea. CDI is estimated to result in around 3,000 deaths annually in the United Kingdom and 15,000 to 20,000 deaths in the United States with associated case fatality rates of 6-17%. CDI is associated with the overgrowth of C. difficile and the production of toxins A and/or B which result in a spectrum of effects, including gut mucosal damage, colitis and pseudomembranous colitis. The control of C. difficile is of high priority for the National Health Service.
About 2/3 of adults have detectable serum antibodies for C. difficile. However, as this is a gut infection the changes in blood do not necessarily reflect the situation at the site of the infection.
Salivary specimens are a very attractive sample type for improving the understanding of the immunology of C. difficile. The antibody responses in saliva is a part of the mucosal immune response and likely to far better reflect the situation at the site of the infection in the gut than blood samples. Also, salivary samples are non invasive, painless, simple and convenient for the patient to produce.
We propose to develop and optimise this salivary ELISA for C. difficile toxin antibodies in saliva of healthy volunteers and compare the results of these assays with the results of conventional blood test ELISAs for C. difficile toxin antibodies.
Potentially these assays could greatly improve the care of patients with CDI and help prevent infections. Risk stratification of patients with a reliable salivary immune assay could greatly improve infection control of this important infection.
REC name
North of Scotland Research Ethics Committee 2
REC reference
13/NS/0164
Date of REC Opinion
22 Nov 2013
REC opinion
Favourable Opinion