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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
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Inclusion Criteria:
Samples that meet all the following criteria will be eligible for enrollment:
Exclusion Criteria:
Samples that meet any of the following criteria will be excluded:
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The study should select subjects that cover the intended population, considering differences in disease, age, and gender. It should not focus on a specific age group to ensure population representativeness. The samples (from the subject) contain interference also need to be involved.
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