Age related reference range assessment of high sensitive troponin I
Research type
Research Study
Full title
Age related reference range assessment of the Abbott Architect High Sensitive Troponin I Assay
IRAS ID
174362
Contact name
Beverly Peel
Contact email
Sponsor organisation
Nottingham Trent University
Duration of Study in the UK
0 years, 2 months, 30 days
Research summary
This research study is designed to evaluate the reference range, and therefore 99th percentile, claims made by Abbott laboratories regarding their high sensitive Troponin I assay. The 99th percentiles are currently reported as 34.2 ng/L for men and 15.6 ng/L for women. This assay is used in the investigation of heart attacks and its implementation has shown a difference in the reference ranges that should be applied for men and women. As well as verifying the reference range currently in use, the study aims to identify any difference seen in different age groups and how a different reference range may be needed to ensure best patient care.
The study requires the analysis of 280 serum samples taken from men and women, over 20 years old. The serum used will be the remaining serum after routine testing has been performed and would have otherwise been discarded.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
15/YH/0342
Date of REC Opinion
17 Jul 2015
REC opinion
Favourable Opinion