Entia Liberty - Capillary Validation
Research type
Research Study
Full title
Entia Liberty: Clinical Performance Validation - Capillary performance
IRAS ID
304718
Contact name
Madeline Lok
Contact email
Sponsor organisation
Entia
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 3 months, 13 days
Research summary
This study forms part of the regulatory submission by demonstrating the performance claims of the device through clinical evidence and will compare results from the device to a gold standard analyser for the following parameters: Neutrophils, Platelets, white blood cells and Haemoglobin, using both capillary and venous blood.
Once consented and deemed suitable for the study, a participant will have a capillary finger prick blood sample taken by a health care professional. This capillary sample will be tested on a Liberty device.
The participant will also have their routine venous blood sample taken as planned, which will be sent to the lab. When they have this blood drawn, a portion of it will be placed in a study specific K2 EDTA tube. This sample will be tested on another Liberty device. Both the venous and capillary sample tested on Liberty devices will have their results compared. These results will also be compared to the gold standard laboratory result.
REC name
London - Stanmore Research Ethics Committee
REC reference
21/LO/0721
Date of REC Opinion
12 Nov 2021
REC opinion
Further Information Favourable Opinion