We evaluated the ACCESS® cardiac troponin I (cTnI) immunoassay as a marker for myocardial infarction (MI). Total imprecision was 6.0% to 13.5%, the minimum detectable concentration was 0.007 μg/L, and the limit of quantitation was 0.046 μg/L. Comparison of cTnI measurement between the ACCESS and Stratus systems (n = 114) showed a proportional difference: ACCESS cTnI = 0.0996 Stratus cTnI + 0.049 μg/L (r = 0.811). Fifty-nine of 61 ambulatory patients without cardiac symptoms had no detectable cTnI (95% range, 0.00 to 0.025 μg/L). The optimum cutoff for discriminating MI (n = 289, 45 with MI) was 0.15 μg/L by receiver operator characteristic curve analysis; at this cutoff, the ACCESS cTnI assay showed a sensitivity of 88.9% (95% CI, 79.7–98.1%) and specificity of 91.8% (95% CI, 88.4–95.2%). The ACCESS cTnI assay results showed 89.4% and 93.0% concordance with the MB isoenzyme of creatine kinase (CK-MB) mass and Stratus cTnI results, respectively, for classification of patients with suspected MI. The ACCESS cTnI assay appears to show sensitivity and specificity comparable with those of both CK-MB mass and Stratus cTnI assays for the diagnosis of MI in patients presenting within 12 h of onset of symptoms.

Availability of markers such as cardiac troponin T (cTnT) has brought new insights into ischemic heart disease (IHD). cTnT is a distinct protein that differs from other markers in biological function, molecular mass, and cytosolic pool. cTnT has been utilized for diagnosis of acute myocardial infarction (AMI) and risk stratification of patients with IHD. For AMI diagnosis, cTnT showed high sensitivity (94-100%) but generally lower specificity (46-99%), possibly because of increases in non-AMI patients with minor myocardial damage. Outcome studies have demonstrated that IHD patients with increased cTnT are at significantly greater risk for cardiac events; revascularization in patients with increased cTnT may improve outcome. Estimated costs for batched ES 300 cTnT results and for a cTnT rapid assay run "on demand" were $17.48 and $21.65, respectively. cTnT currently has no specific common procedure test code; expected reimbursement is $18.32 for the ES 300 and is not established for the rapid assay.

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