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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 27, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 14, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 14, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 3, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 11, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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