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Clinical Chemistry 44: 52-60, 1998;
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Right arrow Proteomics and Protein Markers
(Clinical Chemistry. 1998;44:52-60.)
© 1998 American Association for Clinical Chemistry, Inc.

Enzymes and Protein Markers

Cardiac troponin I measurement with the ACCESS® immunoassay system: analytical and clinical performance characteristics

Robert H. Christenson1,2,a, Fred S. Apple3, David L. Morgan4, Gladys L. Alonsozana1, Kristin Mascotti3, Marilyn Olson5, Robert T. McCormack5, Frank H. Wians, Jr.4, Joseph H. Keffer4, and Show-Hong Duh1

Departments of
1 Pathology and
2 Medical and Research Technology, University of Maryland School of Medicine, Baltimore, MD 21201.
3 Department of Laboratory Medicine and Pathology, Hennepin County Medical Center, Minneapolis, MN 55415.

4 Clinical Pathology, University of Texas Southwestern Medical Center, Dallas, TX 75235-9072.

5 Beckman Instruments, Inc., Chaska, MN 55318-1084.
a Address correspondence to this author at: Clinical Pathology, University of Maryland Medical Center, 22 South Greene St., Baltimore, MD 21201. Fax 410-328-5880; e-mail rchriste{at}umabnet.ab.umd.edu.

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.




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