Application of POCT FBC analyser in neonatal (<3 months) clinical care
Research type
Research Study
Full title
A pilot study to evaluate a novel POCT FBC analyser (Pixcell HemoScreen) for suitability for further CE/UKCA marking research to validate its clinical use in the care of neonates (<3 months)
IRAS ID
334547
Contact name
Nuthar Jassam
Contact email
Sponsor organisation
Harrrogate and District NHS Foundation Trust
Duration of Study in the UK
0 years, 3 months, 1 days
Research summary
The HemoScreen FBC POCT analyser is CE marked for clinical use in patient's that are >3 months of age. This study aims to gather preliminary test data to determine whether the device might be suitable to undertake a full CE marking application for clinical use in patients <3months.
This pilot study aims to directly compare Hemoscreen FBC results against the Lab analyser (Sysmex XN1000) FBC results. The Hemoscreen FBC POCT analyser will be placed on the neonatal ward (SCBU) at Harrogate Hospital. A small volume of the blood sample collected routinely as part of the clinical protocol , will be analysed on the Hemoscreen POCT device before sending the sample to the lab.
The volume required for analysis is very small (40ul). The time of analysis is 5 minutes and the device is mobile so can be brought close to the patient bedside.
The FBC results obtained from the HemoScreen are stored on the device and can be retrieved on a later date. Only 30 samples are required. This amounts to a minimum of 15 patients in total (Maximum two samples per participants during the period of the study).REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
24/WM/0076
Date of REC Opinion
30 May 2024
REC opinion
Further Information Favourable Opinion