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

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

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.

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.