Lab2Go version 001
Research type
Research Study
Full title
Demonstrating Minicare, a miniaturized biophotonics platform for fast and lab-equivalent Point-of-Care diagnostics of Cardiac Troponin-I.
IRAS ID
145489
Contact name
Steve Goodacre
Contact email
Sponsor organisation
Philips Electronics Nederland B.V.
Clinicaltrials.gov Identifier
621035, Project number
Duration of Study in the UK
1 years, 7 months, 30 days
Research summary
Point of care troponin testing can accelerate the diagnosis of heart conditions and improve patient care. A blood sample can be tested by the doctor or nurse to provide troponin measurement during clinical assessment, rather than having to wait for laboratory results. However, current point-of-care technology requires venous blood sampling and separation of cellular blood components prior to analysis. This has acted as a substantial barrier to use of point-of-care technology.
The Magnotech point of care method is a way of detecting very low levels of compounds within the blood. The Magnotech magnetic nanoparticle technology has allowed the development of finger stick point-of-care troponin testing (similar to a BM blood glucose measurement). If the Magnotech point-of-care troponin testing could be shown to be accurate, reliable and inexpensive then it could be used to diagnose heart attack as part of initial assessment in the emergency department. It could also be used by paramedics or urgent care centres to facilitate transfer of patients with heart attack to specialist cardiac care.
Magnotech point of care testing needs further evaluation of analytic validity, i.e. whether the point of care instrument has similar accuracy and produces the same results as conventional laboratory testing, and clinical usability, i.e. whether the technology is easy for frontline clinical staff to use without excessive additional training and can be integrated into routine clinical practice.
This project will test the analytic validity and clinical usability of the Magnotech point-of-care system. Patients with suspected or diagnosed heart disease will be asked to provide an additional fingerstick blood sample and an additional amount of venous blood when they have blood testing for heart attack. These samples will be used to evaluate the Magnotech system in comparison to standard laboratory testing. Patient processes will be recorded and staff feedback sought to assess clinical usability.
REC name
London - Surrey Research Ethics Committee
REC reference
14/LO/2012
Date of REC Opinion
10 Nov 2014
REC opinion
Favourable Opinion