Cardiac troponin I measurement with the ACCESS® immunoassay system: analytical and clinical performance characteristics
| Autor: | Show-Hong Duh, Fred S. Apple, Kristin Mascotti, Robert T. McCormack, Robert H. Christenson, David L. Morgan, Gladys L. Alonsozana, Joseph H. Keffer, Frank H. Wians, Marilyn D. Olson |
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| Rok vydání: | 1998 |
| Předmět: |
medicine.medical_specialty
Pathology biology Receiver operating characteristic medicine.diagnostic_test business.industry Biochemistry (medical) Clinical Biochemistry macromolecular substances musculoskeletal system medicine.disease Troponin Internal medicine Immunoassay Ambulatory Troponin I cardiovascular system medicine biology.protein Cardiology Creatine kinase cardiovascular diseases Myocardial infarction Myocardial infarction diagnosis business |
| Zdroj: | Clinical Chemistry. 44:52-60 |
| ISSN: | 1530-8561 0009-9147 |
| DOI: | 10.1093/clinchem/44.1.52 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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