Access BNP Clinical Performance Evaluation: Testing and Clinical Concordance Study

The goal is to establish clinical performance of a BNP assay on the intended use population and establish clinical concordance on a separate device.

Completed

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Maryland-Baltimore, Baltimore, Maryland, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

There is no direct inclusion criteria for this study, Samples were collected under a separate enrollment protocol

Exclusion criteria

Hemolysis observed per CLSIC56A grading scale
Icterus (bilirubin) observed 4+ per CLSIC56A grading scale

Treatment and study plan

BNP

Diagnostic Test

Blood collected during this study will be tested on separate IUO BNP assay on a separate protocol. No active interventions will occur during this study.

Primary outcomes

Heart failure positive subjects

Time frame: Through study completion, approximately 9 months

Subjects with BNP value above clinical decision point

Secondary outcomes

Heart failure negative subjects

Time frame: Through study completion, approximately 9 months

Subjects with BNP value below clinical decision point

Sponsors and collaborators

Lead sponsor

Beckman Coulter, Inc.

Industry

Registry information

Official study title

Access BNP on DxI 9000 Clinical Performance Evaluation: Specimen Testing and Clinical Concordance Study

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Oct 16, 2025
Registry last updated: Oct 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed