Healthy Clinical Trial
Official title:
Minicare BNP Normal Value Study - MI-BNP-CE02-NV2016
Main objective is to determine normal values for Brain Natriuretic Peptide (BNP) levels for
the Minicare BNP using K2-EDTA (ethylenediaminetetraacetic acid ) venous whole blood and
K2-EDTA plasma samples from healthy subjects.
K2-EDTA whole blood and K2-EDTA plasma samples from approximately 150 normal healthy
volunteer, preferably 50% men and 50% women, will be analysed using the Minicare BNP system.
This will be a single-center study. The study will consist of a 1-day visit for each study
subject on which screening based on a questionnaire, blood draw and discharge will occur. For
each eligible subject, K2-EDTA whole blood will be collected and both K2-EDTA whole blood and
K2-EDTA plasma will be analyzed using the Minicare BNP. Blood donors, presenting voluntarily
at one of the Sanquin posts in, the Netherlands (e.g Eindhoven) will be checked on health
status and selected based on 2 questionnaires. The collected K2-EDTA whole blood tubes from
eligible subjects will be transferred from the Sanquin posts to Philips Eindhoven for
Minicare BNP testing. From one subject, both K2-EDTA whole blood and K2-EDTA plasma will be
measured in singleton. K2-EDTA whole blood and plasma will be measured within 6 hours after
blood collection. The data obtained will be used for determination of normal values of BNP in
a healthy population. Leftover plasma samples (without cells/ RNA/DNA) will be aliquoted and
stored at Philips for potential future analysis/ projects). Testing will be done according to
a DRAFT Instructions for use (IFU) of the Minicare BNP.
n/a
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