Determining Normal Values of BNP Levels for the Minicare BNP IVD Assay.
|ClinicalTrials.gov Identifier: NCT03102944|
Recruitment Status : Completed
First Posted : April 6, 2017
Last Update Posted : October 18, 2017
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.
|Condition or disease||Intervention/treatment|
|Healthy||Diagnostic Test: Minicare BNP|
|Study Type :||Observational|
|Actual Enrollment :||160 participants|
|Official Title:||Minicare BNP Normal Value Study - MI-BNP-CE02-NV2016|
|Actual Study Start Date :||March 21, 2017|
|Primary Completion Date :||March 24, 2017|
|Study Completion Date :||March 24, 2017|
no intervention, extra blood tube taken with blood donation at bloodbank and blood is tested on IVD away from patient.
Diagnostic Test: Minicare BNP
no real intervention since only leftover materials are used from volunteers and samples are not tested on Minicare BNP IVD device near any volunteer.
- Normal values for BNP for the Minicare BNP [ Time Frame: 4 weeks ]To determine normal values for BNP levels for the Minicare BNP using K2- EDTA venous whole blood and K2-EDTA plasma samples from healthy subjects.
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03102944
|Philips EB Handheld Diagnostics|
|Study Chair:||Diederick Keizer||Clinical Affairs Manager|