WholeHealth Products announced the release of the FDA Cleared "Troponin I" rapid test. The Troponin I Whole Blood/Serum Test is an immunoassay for the rapid qualitative detection of cardiac troponin I (cTnl) in human whole blood or serum at a cutoff level of 1.5 ng/mL. It provides an aid in the diagnosis of myocardial infarction in emergency room, pointSHY of-care, and hospital setting.

Several cardiac markers have been used for the diagnosis of acute myocardial infarction {AMI} in the past decade, such as creatine kinase (CK), the MB isoform of creatine kinase (CKMB), lactate dehydrogenase (LOH) isoforms, myoglobin, and cardiac troponins (cTn). Cardiac Troponins exist as a ternary complex with three subunits: cardiac troponin I (cTnl), T (cTnT) and C (cTnC). Investigations showed that both cTnl and cTnT were superior to any of the other cardiac markers because they demonstrated increased sensitivity (>98% at peak concentration) and specificity (95-100%) for AMI over other traditional markers, or even compared to the WHO criteria.

cTnl is released into the blood circulation with levels exceeding the upper reference limit of normal 4-6 hours after the onset of AMI and reaches a peak after 12-24 hours. The high level of cTnl remains for up to 5-7 days. The early release and long duration of cTnl make the test more suitable for the diagnosis of myocardial infarction.

The troponin test is used to help diagnose a heart attack, stroke, TIA's, blood thinning/clotting, determining if the heart is ok for blood thinning medications, to detect and evaluate mild to severe heart injury, and to distinguish chest pain that may be due to other causes. In those who experience heart-related chest pain, discomfort, or other symptoms and do not seek medical attention for a day or more, the troponin test will still be positive if the symptoms are due to heart damage.