AQT90 FLEX NTproBNP (N-terminal Pro-brain Natriuretic Peptide) 2 Test Kit - Clinical Evaluation Study Protocol - China

NTproBNP2 Test Kit (Time-Resolved Immunofluorescence Method) Clinical Evaluation Study Protocol

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07208877

Enrollment

120

Registered

2025-10-06

Start date

2025-10-31

Completion date

2026-01-31

Last updated

2025-10-06

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

Conditions

Diagnostic Tests

Brief summary

To validate the NTproBNP2 Test Kit by using the test results of the predicate device as a reference. It will be demonstrated that the investigational product (NTproBNP2 Test Kit) and the predicate are equivalent. Subsequently, it will be demonstrated that the investigational product can be used in clinical testing.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Inclusion criteria

Samples that meet all the following criteria will be eligible for enrollment: 1. Samples from subjects with current or previous signs and/or symptoms of heart failure, or diagnosed heart failure. 2. Sample-related information is available, including a unique and traceable number, sample type, age, gender, date of sample collection, and clinical diagnosis, etc.. 3. The sample volume is adequate, no less than 2 mL of whole blood. 4. The sample collection shall meet the informed consent waiver requirements of the ethics committee.

Exclusion criteria

Samples that meet any of the following criteria will be excluded: 1. Duplicate collection of samples from the same subject. 2. Samples that do not meet the collection, handling, and storage requirements outlined in the product's instructions for use. 3. Samples that are suspected of being poor quality, i.e. samples suspected of containing clots, visible hemolysis or lipids, or samples suspected of being contaminated with possible interfering substances.

Design outcomes

Primary

Measure	Time frame	Description
AQT90 FLEX NTproBNP2 Test Kit - Clinical Evaluation - China	12 months	Clinical evaluation indicator: The correlation coefficient between the investigational reagent and the predicate. Evaluation criteria: The correlation coefficient between the investigational reagent and the predicate shall not be less than 0.95. The slope should be within the range of \[0.9, 1.1\]. If this requirement is not met, it is recommended to increase the sample size and provide a detailed rationale.

Outcome results