Determining Normal Values of BNP Levels for the Minicare BNP IVD Assay.
NCT ID: NCT03102944
Last Updated: 2017-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
160 participants
OBSERVATIONAL
2017-03-21
2017-03-24
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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healthy volunteers
no intervention, extra blood tube taken with blood donation at bloodbank and blood is tested on IVD away from patient.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Willing and able to sign the informed consent form (ICF)
Exclusion Criteria
* Subjects with a history of cardiac and/or vascular disease, renal dysfunction, cancer, COPD or instable diabetes are not allowed to donate blood.
18 Years
ALL
Yes
Sponsors
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Philips Handheld Diagnostics
INDUSTRY
Responsible Party
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Principal Investigators
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Diederick Keizer
Role: STUDY_CHAIR
Clinical Affairs Manager
Locations
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Philips EB Handheld Diagnostics
Eindhoven, , Netherlands
Countries
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Other Identifiers
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HHDx-07998
Identifier Type: -
Identifier Source: org_study_id