Entia Liberty: Accuracy and Precision
Research type
Research Study
Full title
Entia Liberty: Analytical Performance Validation- Accuracy and Precision
IRAS ID
304727
Contact name
Elaine Dunwoodie
Contact email
Sponsor organisation
Entia Ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 2 months, 30 days
Research summary
Entia is producing a home-monitoring solution for cancer patients that measures haemoglobin (Hb) total white blood cell count (WBC), Neutrophil count (ANC) and Platelet count (PLT).
This study will aim to evaluate the performance (bias, total error and linearity) of the device by comparing the results of 400 excess venous blood samples from a gold standard laboratory analyser, to results from the Entia Liberty device, from the same blood sample. In addition to that, this study aims to evaluate the precision of the Entia Liberty device. This is done by running 30 chosen excess venous blood samples to be each split into 10 individual samples to be tested on the device.
The excess blood samples will be collected from the haematology labs from the study site. They will be flagged according to our inclusion/exclusion criteria to the research team who will then test the samples on the Entia Liberty devices. No patients will be explicitly consented for this study but posters informing patients that their anonymous excess blood sample may be used for research purposes and they may opt out of it if they would like to. Excess samples obtained from tissue banks will be taken from patients who have given consent on generic tissue bank consent forms.
REC name
London - Stanmore Research Ethics Committee
REC reference
21/LO/0852
Date of REC Opinion
22 Dec 2021
REC opinion
Further Information Favourable Opinion