A rapid, definitive diagnosis of AMI is vital – minutes are critical. Around 85% of patients presenting with chest pain do not have AMI. Traditional tests can take hours. And in 2% to 8% of cases a positive AMI diagnosis is dangerously missed. The result is strain on resources, huge costs and misdiagnosis fatalities. The total cost of unnecessary admissions and misdiagnosis reaches billions of dollars a year.
Standard procedure for chest pain patients is an immediate ECG, complemented by blood tests for the cardiac markers troponin I or T, to diagnose AMI. However, the sensitivity of an ECG is recognized as only around 55%-75% accurate. And these standard troponin tests provide only guidance; as troponin levels rise over time and are difficult to detect during the early stages.
The solution is the detection of very low levels of cardiac markers (troponin I and T) using high sensitivity cardiac troponin assays (biomarker detection/measurement process). Gold standard laboratory analyzers currently required to run these high sensitivity tests can give up to a 99.6% Negative Predictive Value (the probability of no AMI): two thirds of suspect patients might be “ruled out” and safely discharged early. However, laboratory analyzers are located centrally, extremely expensive, slow to turnaround results (typically 60 minutes) and high sensitivity troponin tests performed on these analyzers have yet to be approved for clinical use in the United States.