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Determining Normal Values of BNP Levels for the Minicare BNP IVD Assay.

NCT03102944 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 160

Last updated 2017-10-18

No results posted yet for this study

Summary

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.

Conditions

  • Healthy

Interventions

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.

Sponsors & Collaborators

  • Philips Handheld Diagnostics

    lead INDUSTRY

Principal Investigators

  • Diederick Keizer · Clinical Affairs Manager

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-21
Primary Completion
2017-03-24
Completion
2017-03-24

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03102944 on ClinicalTrials.gov