The SALCO Study
Research type
Research Study
Full title
A study of the limits of agreement of measurements of salivary cortisol by a µPAD-MS system compared to Liquid Chromatography-Tandem Mass Spectrometry
IRAS ID
281878
Contact name
Joanne Blair
Contact email
Sponsor organisation
Alder Hey Children's NHS Foundation Trust
Duration of Study in the UK
0 years, 5 months, 27 days
Research summary
Cortisol is a hormone produced by the adrenal gland. People with insufficient cortisol feel excessively tired, nauseous, have a poor appetite, complain of abdominal pain and headache, lose weight and have poor concentration. Children may grow poorly. Patients may experience life threatening ‘adrenal crisis’ during periods of physical stress.
It has been possible to measure cortisol in saliva for some time. However, current methods are time consuming and require an experienced technician. Only a small number of laboratories offer this service and it can take so long to process a sample that the results are no longer meaningful by the time clinical teams receive them.
University of Liverpool scientists are developing a new method for measuring cortisol in saliva using a new device [microfluidic paper-based devices (µPADs)] and a laboratory technique called mass spectrometry. This technology is simpler and faster than the standard method, and does not require a trained technician. This study is the first step in the development of this new technology.
Methods
Patients attending the Medical Day Unit for tests that include cortisol blood tests will be invited to participate. A week before their appointment the family will be contacted and information about the study will be shared. Consent will be obtained from parents and young people, and assent will be obtained from children where appropriate.
The patient will be invited to provide a saliva sample when a blood sample is collected. This sample will be split in two: Cortisol will be measured in one half using the standard method and the new method in the other half. We will compare the cortisol measurements made by the new technique to those made by the standard method, and to measurements made in the blood sample. In this way we will find out how well the new method works.REC name
London - South East Research Ethics Committee
REC reference
20/PR/0842
Date of REC Opinion
19 Jan 2021
REC opinion
Further Information Favourable Opinion