Evaluation of the Samsung LABGEO IVD-A20 CHF Test in a Point-of-Care Setting

Study Overview
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Brief Summary
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To establish the performance characteristics of the Samsung LABGEO IVD-A20 CHF Test in intended use settings, by comparing test results of the A20 CHF Test with results obtained from an FDA-cleared comparator assay.

Official Title
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Evaluation of the Samsung LABGEO IVD-A20 CHF Test in a Point-of-Care Setting

Conditions
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Congestive Heart Failure

Intervention / Treatment
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* Device: Samsung LABGEO IVD-A20 CHF Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CHF Subjects: 21 years of age or greater, with clinically confirmed CHF or have presented to the clinical site with signs, symptoms and/or risk factors suggestive of heart failure. Subjects with Potentially confounding comorbidities: Non-CHF subjects 21 years of age or greater, with potentially confounding comorbidities such as diabetes, renal insufficiency, hypertension and chronic obstructive pulmonary disease (COPD) Healthy Subjects: apparently healthy subjects greater than 45 years of age, with no prior history of cardiac-related disease. Exclusion Criteria: Apparently healthy subjects with a history of MI, CHF or other cardiac-related disease; Subjects with acute decompensated heart failure currently on nesiritide therapy; Subjects having participated in another experimental drug, biologic, or invasive device study within 30 days prior to signing informed consent for this study, or enrolled concurrently in any other investigative study; and Subjects unable to or refusing to provide written informed consent.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CHF-confirmed subjects<br>Subjects 21 years of age or greater with clinically confirmed heart failure or have presented to the clinical site with signs, symptoms and/or risk factors suggestive of heart failure. | Device: Samsung LABGEO IVD-A20 CHF Test<br> <br> * Other names: LABGEO IVD-A20 CHF Test, A20 CHF Test,;|
| Subjects with potentially co-morbidities<br>non-CHF subjects 21 years or greater, with potentially confounding comorbidities such as diabetes, renal insufficiency, hypertension and chronic obstructive pulmonary disease (COPD). | Device: Samsung LABGEO IVD-A20 CHF Test<br> <br> * Other names: LABGEO IVD-A20 CHF Test, A20 CHF Test,;|
| Apparently healthy subjects<br>Apparently healthy subjects (meeting inclusion criteria) greater than 45 years of age, with no prior history of myocardial infarction (MI), acute coronary syndrome (ACS) congestive heart failure (CHF) or any other cardiac-related disease. | Device: Samsung LABGEO IVD-A20 CHF Test<br> <br> * Other names: LABGEO IVD-A20 CHF Test, A20 CHF Test,;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of clinically-confirmed CHF subjects for whom the Samsung LABGEO IVD-A20 CHF Test result was positive (clinical sensitivity). |  | baseline | 
| The proportion of non-CHF subjects for whom the LABGEO IVD A20 CHF Test result was negative (clinical specificity). |  | baseline | 
| Using a Passing-Bablok regression analysis, estimates of intercept and slope will be computed. Estimates of bias and corresponding 95% confidence interval for true bias at clinical decision threshold of 125mg/mL and 450 pg/mL will also be computed. | Method comparison will be assessed using a Passing-Bablok regression analysis to determine the relationship between the Samsung LABGEO IVD-A20 CHF Test measurement in plasma and the corresponding measurement in plasma obtained from the comparator assay. | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects with a positive LABGEO IVD-A20 CHF Test result, for whom a clinical diagnosis of CHF was confirmed (positive predictive value). |  | baseline | 
| The proportion of subjects with a negative LABGEO IVD-A20 CHF Test result, for whom a clinical diagnosis of CHF was confirmed (negative predictive value). |  | baseline | 
| Computation of Receiver Operating Characteristic (ROC) curve and area under the curve (AUC) with 95% confidence interval for the true AUC. | This analysis will assess the ability of the Samsung LABGEO IVD-A20 CHF Test to discriminate between confirmed CHF subjects and non-CHF subjects. | baseline | 
| Variance components analysis will be conducted on data collected from each whole blood specimen undergoing point-of-care precision testing at study site. Estimates of within-run, between run, between day and total precision will be computed. | The Samsung LABGEO IVD-A20 CHF Test result will be modeled as a function of testing days and runs, with replicates fully nested within runs, and runs fully nested within days. | 10 days | 
| Variance components analysis will be conducted on data collected from each plasma specimen undergoing point-of-care precision testing at study site. Estimates of within-run, between run, between day and total precision will be computed. | The Samsung LABGEO IVD-A20 CHF Test result will be modeled as a function of testing days and runs, with replicates fully nested within runs, and runs fully nested within days. | 20 days | 
| Mixed model regression analysis will be conducted on each specimen type (whole blood vs. plasma) and storage condition. | The natural logarithm of the Samsung LABGEO IVD-A20 CHF Test measurement will be modeled as a linear function of time (in hours) after baseline testing.A separate linear function will be fitted to data collected from each study specimen and the intercepts and slops from individual specimens will be modeled as random effects. | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CHF