Clinical Study to Validate the Use of a New Point of Care Troponin I Test
Clinical Study to Validate the Use of a New Point of Care Troponin I Test
This trial is designed as a prospective, multi-center, observational study of "all-comers"
 eligible adult subjects presenting to participating emergency departments with symptoms
 suggestive of acute coronary syndrome (ACS)
This trial is designed as a prospective, multi-center, observational study of "all-comers"
 eligible adult subjects presenting to participating Emergency Departments (EDs) with symptoms
 suggestive of ACS and/or myocardial ischemia. Subjects presenting with symptoms suggestive of
 ACS will be screened and approached for consent for study enrollment by trained personnel.

 After obtaining written informed consent, subjects will have up to 4 blood samples collected
 for cTnI testing using the Meritas Troponin I test and Meritas point-of-care (POC) Analyzer.
 Blood draws and testing will occur at 4 intervals over 24 hours.
Inclusion Criteria:

 1. The informed consent must be signed by the subject, or the subject's legal authorized
 representative.

 2. 21 years of age or greater at the time of enrollment

 3. Subjects presenting to the ED with any symptoms suggestive of ACS and/or myocardial
 ischemia, such as but not limited to: subjects currently having chest pain, pressure
 or a burning sensation across the precordium and epigastrium, pain that radiates to
 neck, shoulder, jaw, back, upper abdomen and either arm.

 Exclusion Criteria:

 1. Informed consent form not signed

 2. Age <21 years

 3. Known pregnancy -