Development of an LC-MS/MS C-peptide method for Dry Blood Spot samples
Research type
Research Study
Full title
Development and validation of a candidate liquid chromatography tandem mass spectrometry (LC-MS/MS) C-peptide reference method and a protocol for testing Dry Blood Spot (DBS) samples for use in clinical diagnostics
IRAS ID
247518
Contact name
Ben de Lacy Costello
Contact email
Sponsor organisation
University of the West of England
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
The body uses glucose, for energy and other cellular functions. Insulin, a hormone produced by beta cells in the pancreas, is required to move glucose into cells before it can be used. In type 2 diabetes, the body loses its ability to produce enough insulin or respond to insulin. Laboratory measurement of insulin to assist in the treatment of type 2 diabetes is difficult because insulin levels changes quite rapidly in blood. The measurement of C-peptide which is released by the pancreas at the same time and amount as insulin is a better alternative. Current measurement of C-peptide is through the use of serum, plasma and urine samples using immunoassay technology. There is significant variation in results from one laboratory to another because standardisation of C-peptide measurement between laboratories has still not been achieved worldwide. This makes interpretation of results in clinical care complicated as results from different laboratories will be different.\nTherefore, the primary aim of the study is to establish a reference method for C-peptide measurement in the UK by developing a gold standard method using LC-MS/MS. LC-MS/MS is more sensitive and overcomes many of the difficulties encountered in immunoassay. \nBuilding on this and taking advantage of the smaller sampling requirement and simplified sample collection and handling, this research proposes that C-peptide measurement via LC-MS/MS will have an increased impact if Dry blood spot (DBS) can be used as a sample of choice in paediatrics and elderly patients. DBS is a finger prick sample taken on a collection card, same as the heal prick sample collection protocol used in New-born screening. DBS sample collection can be conveniently done by patients at home when several C-peptide measurements are required such as in the investigation of low blood glucose (hypoglycaemia) or in clinical trials as well as in renal transplants.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
19/YH/0335
Date of REC Opinion
24 Sep 2019
REC opinion
Unfavourable Opinion