Evaluation of new highly sensitive C. difficile toxin immunoassay
Research type
Research Study
Full title
Evaluation of a new high sensitive enzyme immunoassay for the detection of C. difficile toxins A and B
IRAS ID
194911
Contact name
Kerrie Davies
Contact email
Sponsor organisation
bioMerieux S.A.
Duration of Study in the UK
1 years, 5 months, 30 days
Research summary
Clostridium difficile is an organism that can cause mild to severe diarrhoea and may cause life threatening disease. It is usually diagnosed in the laboratory by assays that either detect the organism, its toxins or its genetic material (DNA). There is still some dispute about the best method to detect the disease, but there is now beginning to be a consensus that detecting the toxins that cause the disease (rather than the organism itself) is the most clinically important method. In the past there have been issues with the sensitivity of some of these toxin assays (i.e. how good they are at not missing positive results). The most sensitive is the Cell Cytotoxicity Neutralisation Assay (CCNA), which is used at Leeds. The test takes a longtime to complete (up to 48 hours) so does not give a very timely result for patients. Enzyme immunoassays use antibodies to detect the toxins produce by the organism C. difficile. Historically however, these tests have been poor at detecting positive samples (low sensitivity). A new, highly sensitive automated enzyme immuoassay for detection of C. difficile toxins has been dveloped. This study aims to compare that new rapid test to the most sensitive test available (CCNA) by testing patient samples with both assays and comapring the results to detmine the best cut-off value (i.e. which samplea are called positive by the test) for the new test. Addtionally, sequential faecal samples will be collected from a small number of patients to determine the in-vivo limits of detection of the assay.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
16/YH/0411
Date of REC Opinion
11 Nov 2016
REC opinion
Further Information Favourable Opinion