Method and Sample Comparison Study Minicare BNP - COMP-BNP-CE03-AN2016

September 7, 2017 updated by: Philips Handheld Diagnostics

Method and Sample Comparison Study of Minicare BNP at a Central Laboratory

Sample Comparison The objective of this study is to compare the Philips Minicare BNP test with the Centaur BNP test. BNP level measured in human blood samples (EDTA venous whole blood and/or EDTA plasma) will be assessed. Matrix Comparison To compare BNP measurements obtained using Minicare System for EDTA whole blood and EDTA plasma samples.Prior to the study start, a proficiency study will be performed on the Minicare BNP, Architect and I-STAT BNP assay to be sure that devices are performing according to expectations. Approximately 100 EDTA patient whole blood samples covering the entire measuring range of Minicare BNP from LOQ until end of measuring range (expected to be approximately 5000 ng/L) (Ref 7) will be tested (according to CLSI EP09A3 (Ref 5)) at a central laboratory using the Minicare BNP, Alere BNP, I-STAT BNP system. The outcome of the site routine assay (Centaur BNP systems) will be used to evaluate if the blood samples cover the entire distribution range of the assay. If necessary, up to 20% of the samples may be spiked so that the entire range of the assay is covered. The central laboratory will identify the blood tubes with a BNP request. Approximately 1000 μl EDTA whole blood will be available (left over material) for testing on the non-routine devices (i.e., Minicare BNP, Alere BNP, and I-STAT BNP). Testing for the Alere BNP, I-STAT BNP, and Centaur BNP systems will be performed according to the respective IFU's (Ref 1, 2, 3, 4). For the Minicare BNP system, test will be performed according to a DRAFT IFU or a similar document describing the sample treatment and handling for the Minicare BNP system. Alere BNP, I-STAT BNP and Minicare BNP samples should be tested within 6 hours after collection and Centaur BNP samples within 8h of collection. Although different stability claims for BNP, it is highly recommended to perform all measurements on all systems within 2 hours. For Alere BNP, I-STAT BNP, Centaur BNP analysis will be performed using a single blood sample for each patient. Alere BNP and I-STAT will use EDTA whole blood samples as sample type Centaur BNP will be tested on EDTA plasma samples. For the Minicare BNP, both EDTA whole blood and EDTA plasma will be tested for each patient. For the Minicare BNP system the whole blood samples will be tested using a pipette and the same sample will be tested using the SmearSafe Blood Dispenser (transfer device) to investigate a reliable use of such transfer device.

Only the routine Centaur BNP outcomes will be used as part of support for patient diagnosis.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

296

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Eindhoven, Netherlands
        • Diagnostiek voor U

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Left over blood samples from eligible patients with BNP requests, available at the test site Central laboratory

Description

Left over blood samples from eligible patients with BNP requests, available at the test site CENTRAL LABORATORY will be selected for this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To investigate the bias between the Philips Minicare BNP test with the Centaur BNP test of the measurement procedures.BNP level measured in human blood samples (EDTA venous whole blood and/or EDTA plasma) will be assessed.
Time Frame: May 2017
To investigate the bias between the Philips Minicare BNP test with the Centaur BNP test using values spanning the common measuring interval of the measurement procedures.BNP level measured in human blood samples (EDTA venous whole blood and/or EDTA plasma) will be assessed.
May 2017
To compare BNP measurements obtained using Minicare System for EDTA whole blood and EDTA plasma samples.
Time Frame: May 2017
To compare BNP measurements obtained using Minicare System for EDTA whole blood and EDTA plasma samples.
May 2017

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of agreement systems
Time Frame: May 2017
To estimate the percent of agreement between the Minicare System and three commercially available BNP systems (i.e., Alere BNP, I-STAT BNP, and Centaur BNP tests) using a cut-off value of 100ng/L.
May 2017
Percentage of agreement samples
Time Frame: May 2017
To estimate the percent of agreement between EDTA whole blood and EDTA plasma samples for Minicare system using a BNP cut off value of 100ng/L
May 2017
Evaluate performance of the SmearSafe Blood Dispenser (transfer device), for transferring whole blood from the blood tube directly to the Minicare BNP cartridge.
Time Frame: May 2017
Evaluate performance of the SmearSafe Blood Dispenser (transfer device), for transferring whole blood from the blood tube directly to the Minicare BNP cartridge, so without use of pipette.
May 2017

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philips Handheld Diagnostics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 27, 2017

Primary Completion (ACTUAL)

April 14, 2017

Study Completion (ACTUAL)

April 14, 2017

Study Registration Dates

First Submitted

April 3, 2017

First Submitted That Met QC Criteria

April 7, 2017

First Posted (ACTUAL)

April 13, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 11, 2017

Last Update Submitted That Met QC Criteria

September 7, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HHDx-07952

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data that come out of study may be used to publish.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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