Clinical Performance Evaluation of AQT90 FLEX TnI and TnT

AQT90 FLEX TnI and TnT - Clinical Sensitivity and Specificity Study

The AQT90 FLEX Troponin I (TnI) and Troponin T (TnT) Tests are in vitro diagnostic assays intended as an aid in the diagnosis of myocardial infarction (MI) in point-of-care and laboratory settings. The purpose of the study is to establish the clinical performance of the AQT90 FLEX TnI and TnT assays for both whole blood and plasma in the intended use population.

Inclusion Criteria:

• Subject is 21 years of age or older.
• Subject is able to understand information given, and willing and able to voluntarily give their consent to participate in this study.
• Subject is presenting to the ED with acute chest pain or equivalent ischemic symptoms suggestive of ACS or MI (e.g., acute chest pain/pressure, shortness of breath, discomfort in upper extremity, jaw or epigastrium, diaphoresis, nausea, vomiting, lightheadedness, dizziness, weakness, and/or syncope).

Exclusion Criteria:

• Subject is pregnant or may be pregnant.
• Subject has an invalid written informed consent or has withdrawn consent.