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.