VITROS Immunodiagnostic Products hs Troponin I

A prospective clinical sample collection and cardiac troponin I testing will be conducted in
individuals presenting to the Emergency Department (ED) with signs and/or symptoms suggestive
of acute coronary syndrome (ACS) at geographically dispersed sites in the US. Individuals who
meet the inclusion/exclusion criteria, including having signed an informed consent form will
be included in the study.

Clinical and laboratory data will be collected to demonstrate product performance compared to
an adjudicated clinical diagnosis.

Sample collection and testing of clinical samples with the VITROS hs Troponin I test will be
performed under two separate protocols.

Inclusion Criteria:

1. Subject must be ≥22 years of age at the time of consent.

2. Subject presenting with symptoms suggestive of acute coronary syndrome including chest
pain, or chest pain equivalent.

3. Must have an Electrocardiogram (ECG) ordered as part of the subject's standard of
care.

4. Subject willing and able to provide informed consent.

Exclusion Criteria:

1. Subject is unable to comply with the study requirements.

2. Any samples which were not obtained under IRB approved protocol.