Analytical and clinical evaluation of new diagnostic tests for myocardial damage

As with any new test, novel cardiac markers must meet basic analytical and clinical performance issues. For sensitivity and specificity, it is important to know what protein forms are released into blood after injury, and which of these forms are measured by the assays in question. When commercial tests become available, the choice of the measurement platform will be important in the timely delivery of results. The cut-off concentration used is also important, and requires careful selection of the patient groups to be studied. If the intent of the marker is to be used to diagnose acute myocardial infarction (AMI), data from normal subjects should not be included. However, low cut-off limits can be useful for detection of minor myocardial injury if the new assay is highly sensitive and specific. New tests are needed in the area of early diagnosis of AMI, detection of reinfarction or myocardial extension after AMI, risk stratification of patients with unstable angina, and therapeutic monitoring of patients with congestive heart failure. The most promising new markers are glycogen phosphorylase BB, free fatty acid binding protein, and brain natriuretic peptide.