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
Godwin K Tetteh
Contact email
Sponsor organisation
University of the West of England
Duration of Study in the UK
0 years, 3 months, 30 days
Research summary
The inability of the body to produce enough insulin or respond to insulin causes diabetes. C-peptide is a laboratory test that is used in diabetic patients to investigate how much insulin the body is able to produce. The test helps the doctor to decide whether insulin administration is required in the management of diabetes. Current laboratory methods for the measurement of C-peptide is through the use of immunoassay technologies which have significant downfalls. Immunoassays use antibody and antigen reactions which are subject to interferences, resulting in inaccurate test results. There is also significant variation in results from one lab to another in the UK because the standardisation of C-peptide measurements has not been achieved yet. This makes the interpretation of results in clinical care complicated.
Therefore, the primary aim of the study is to develop a C-peptide measurement method using liquid chromatography-mass spectrometry technology (LC-MS/MS) for serum/plasma samples. LC-MS/MS is more sensitive and overcomes the difficulties encountered in immunoassays. An LC-MS/MS method can also be used as a reference method which is a requirement for standardisation of assays. There is currently no C-peptide LC-MS/MS method developed in the UK.
Building 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 particularly in paediatrics and elderly patients. DBS is a finger prick sample taken on a DBS collection card which is the same process as the heel 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 residual pancreatic function or in clinical trials.
REC name
London - Surrey Research Ethics Committee
REC reference
24/LO/0104
Date of REC Opinion
16 Feb 2024
REC opinion
Further Information Favourable Opinion