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The Ischemia Albumin Cobalt Binding Test (ACB®) is a quantitative in vitro diagnostic test used on human serum that detects Ischemia Modified Albumin (IMA™) by measuring the cobalt binding capacity of albumin in human serum. IMA is intended for use in conjunction with ECG and cardiac troponin as an aid to the short term risk stratification of patients presenting with chest pain suggestive of cardiac origin. Thus, in patients with chest pain or equivalent symptoms suggestive of cardiac origin, with non-diagnostic ECG and normal troponin, a negative IMA can be used as an aid to rule out Acute Coronary Syndrome (ACS) in low risk patients. The safety and effectiveness of this device for use in patients with potential Acute Coronary Syndrome (ACS) with negative ECG; or positive ECG; or positive ECG combined with negative, low, or normal troponin levels; or positive troponin levels also has not been established. IMA results do not correlate with blood flow and in the event of a positive IMA, ECG, or troponin test result, could be misleading as either ruling in or ruling out ACS.

The Ischemia ACB® Test measures the cobalt binding capacity of albumin in a serum specimen. Cobalt is added to serum and allowed to react. Dithiothreitol (DTT), a colorimetric indicator, is added to the reacted specimen and the degree of color formation is detected spectrophotometrically on clinical chemistry analyzers. In normal patients, cobalt binds at the N-terminus of albumin leaving little cobalt to react with DTT and form a colored product. In serum of patients with ischemia, cobalt does not bind to the metal binding sites leaving more free cobalt to react with DTT and form a darker color.

The Albumin Cobalt Binding Test (ACB® Test) is a quantitative in vitro diagnostic test used on human serum that detects Ischemia Modified Albumin (IMA™) by measuring the cobalt binding capacity of albumin in human serum. IMA is intended for use in conjunction with ECG and cardiac troponin as an aid to the short term risk stratification of patients presenting with chest pain suggestive of cardiac origin. Thus, in patients with chest pain or equivalent symptoms suggestive of cardiac origin, with non-diagnostic ECG and normal troponin, a negative IMA can be used as an aid to rule out Acute Coronary Syndromes (ACS) in low risk patients.

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