The Mindray High Sensitivity Troponin-I Measurement System is an in vitro diagnostic test for the quantitative determination of high sensitivity cardiac troponin I (hs-cTnI) in human serum or plasma. The Mindray High Sensitivity Troponin-I Measurement System is to be used as an aid in the diagnosis and rule out of acute myocardial infarction (AMI).
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Examine the incidence of undetectable(<LoD), measurable (LoD - 99th percentile), and increased (>99th percentile) cTn concentrations for the Mindray Bio-Medical hs-cTnI assay using the CL-1200i analyzer.
Timeframe: Day 1
Examine Concordance
Timeframe: Day 1
Examine the diagnostic performance for acute myocardial injury and acute myocardial infarction.
Timeframe: Day 1
Describe the incidence of MI and myocardial injury, clinical characteristics and 30-day safety outcomes risk of patients with and without hs-cTnI increases above the sex-specific 99th percentile URLs
Timeframe: Day 1
Impact on the incidence of myocardial injury and myocardial infarction diagnoses.
Timeframe: Day 1