Access BNP Clinical Performance Evaluation: Testing and Clinical Concordance Study

Beckman Coulter

Status: Completed

Conditions: Heart Failure

Treatments: Diagnostic Test: BNP

Study type: Observational

Funder types: Industry

Identifiers

NCT07217431

BNP-02-23

Details and patient eligibility

About

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

Enrollment: 1,361 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,361 participants in 1 patient group

Subjects with heart failure

Description:

Targeting subjects in the acute care setting that present with suspicion of either new onset or worsening symptoms of heart failure

Treatment:

Diagnostic Test: BNP