Comparative study of devices for skin prick blood sampling.
Research type
Research Study
Full title
Comparative study of haemolysis levels using different devices for skin prick blood sampling in healthy volunteers.
IRAS ID
295335
Contact name
Fiona Karet
Contact email
Sponsor organisation
Kalium Health Ltd
Duration of Study in the UK
0 years, 3 months, 3 days
Research summary
Kalium Health Ltd, a spin-out from Professor Karet's lab at the University of Cambridge, is in the process of developing a novel test for blood potassium levels that can be used by at home patients, and by healthcare providers in primary or outside of clinical settings. It will require only a few microlitres of blood, in the same way as millions of people with diabetes prick their fingers to check blood glucose or alternatively in the 'bleeding time test' used by hematologists.
However - and different to current tests - when checking potassium it is essential to minimise rupture of red blood cells (haemolysis) so as not to get a falsely high potassium result. We therefore need to select the smoothest method of obtaining the tiny blood drop.
This study will compare the amount of haemolysis in samples, obtained using different available micro-lancets from the finger or forearm, in a group of healthy volunteers.
Volunteers will attend on two or three occasions (according to their preference). On each they will be asked to provide a combination of fingerstick and forearm samples using different lancets.
The procedures involved are already in safe routine use by people with diabetes themselves, and in haematology settings, and no major adverse consequences are predicted.
This information will allow us to select the best method for future studies involving both healthy volunteers and patients with potassium disorders, once the testing device is ready.REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
21/PR/0517
Date of REC Opinion
2 May 2021
REC opinion
Further Information Favourable Opinion