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

N/ANot Yet RecruitingNCT07208877

Radiometer Medical ApS120 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

120

Conditions

Diagnostic Tests

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

AQT90 FLEX NTproBNP2 Test Kit - Clinical Evaluation - China

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.

Time frame: 12 months

Data from ClinicalTrials.gov

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