PERFORMDX
Research type
Research Study
Full title
Performance Evaluation of a rapid diagnostic (Dx) test for NTproBNP
IRAS ID
364083
Contact name
Roy Gardner
Contact email
Sponsor organisation
JEMMDx Limited
Duration of Study in the UK
0 years, 3 months, 2 days
Research summary
This is a performance evaluation of an in vitro diagnostic (IVD) test device using blood samples (capillary and venous whole blood) from human subjects together with collection of limited clinical data. Subjects 18 years or older are presenting into hospital with symptoms of heart failure or have a confirmed diagnosis of heart failure. The fingerstick (capillary) blood is collected by a healthcare professional from a patient and placed onto a test strip within a small hand-held instrument. The instrument determines how much of a protein (called NTproBNP) is present. This value is compared to the level of the same protein when tested on an approved laboratory analyser (the reference method) using a venous blood sample from the same patient. The 2 values are compared to check that the new test using a fingerstick blood sample can give the same result as found when sending a venous blood tube to the laboratory. The new test once approved could be used in clinical sites to give a fast answer from a small amount of blood in patients with suspected heart failure, or those undergoing therapy and could be used in the Emergency department, in primary and community care sites.
REC name
West of Scotland REC 1
REC reference
25/WS/0173
Date of REC Opinion
16 Dec 2025
REC opinion
Further Information Favourable Opinion