Diagnostic accuracy of an enteric biochip array
Research type
Research Study
Full title
Diagnostic accuracy study of a molecular biochip array for the detection of enteric pathogens
IRAS ID
244407
Contact name
Ronan McMullan
Contact email
Sponsor organisation
Queens University Belfast
Duration of Study in the UK
2 years, 1 months, 31 days
Research summary
Diarrhoeal infectious diseases account for around two million deaths per year, ranking third among all causes of infectious causes of death, worldwide. Most of these occur in children under five years of age. An average of 3.2 episodes of diarrhoea per year per child has been reported, but in developing countries, it may be as high as 12 episodes per year per child. While these 'enteric' infections can be self-limiting in healthy individuals they can present more severely especially in children, elderly and immunosuppressed patients with subsequent dehydration being a common complication. Additionally, outbreaks relating to contaminated water or food is a public health concern. It is advantageous to rapidly identify the causative agent to ensure appropriate treatment of patient and also to allow appropriate infection control measures to be implemented to limit spread of infection. Standard diagnostic tests are laborious, require specialist expertise and can take several days for a result to become available.
This project will evaluate a new rapid test to help with the diagnosis of enteric infections. We will use faecal material from patients that is left over after routine testing in hospital Microbiology laboratories to allow us to evaluate an Enteric Biochip Array Technology (BAT) developed by Randox laboratories Ltd. This new test is capable of simultaneously detecting a range enteric pathogens and can generate a result within 1 working day. Results from the biochip will be compared directly to the routinely used technique at the clinical microbiology laboratory that each sample was sourced from and test performance characteristics (i.e. sensitivity and specificity) will be assessed.
REC name
Wales REC 7
REC reference
19/WA/0169
Date of REC Opinion
24 May 2019
REC opinion
Favourable Opinion