Access BNP Clinical Performance Evaluation: Testing and Clinical Concordance Study

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07217431

Enrollment

1361

Registered

2025-10-16

Start date

2024-10-10

Completion date

2025-03-25

Last updated

2026-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Brief summary

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

Interventions

DIAGNOSTIC_TESTBNP

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.

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

22 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Number of participants with BNP value above clinical decision point	Through study completion, approximately 9 months	Subjects with BNP value above clinical decision point - Heart Failure Positive

Secondary

Measure	Time frame	Description
Number of participants with BNP value below clinical decision point	Through study completion, approximately 9 months	Subjects with BNP value below clinical decision point - Heart failure negative subjects

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Oct 7, 2026