To establish blood analyte 99th percentile levels for Osler assays
Research type
Research Study
Full title
To establish blood analyte 99th percentile levels for Osler Origin assays from a defined healthy population group using surplus/nonclinical issue blood samples from NHS pathology laboratories and NHSBT.
IRAS ID
318831
Contact name
Yat Hong Leung
Contact email
Sponsor organisation
Osler Diagnostics
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Translation of the Osler diagnostic platform into a clinically validated Point of Care (PoC) devices, comprising of an easy-to-use cartridge and associated reader to allow for rapid testing (10 minute) of cardiac markers within whole blood samples.
The aim of this study is to use blood samples from cardiac healthy patients to establish the analyte 99th percentile from an apparently healthy donor population.
Typically, 4-6ml of EDTA whole blood is needed per donor, where the blood cellular material will be destroyed and discarded post testing on the same day of receipt. Resulting acellular material (plasma) will be stored for future testing. No cellular material from the study will be stored onsite for longer than 24hrs.
The subjects will be partitioned by gender and age group. All samples will be fully anonymised, no traceability will exist to the original donor
Individual donor EDTA whole blood sample s from NHS pathology laboratories and NHSBT will be sent via specialised cool transport courier to Osler Diagnostics .
REC name
London - Surrey Research Ethics Committee
REC reference
22/PR/1389
Date of REC Opinion
16 Nov 2022
REC opinion
Further Information Favourable Opinion