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

被引:0
|
作者
Christenson, RH
Apple, FS
Morgan, DL
Alonsozana, GL
Mascotti, K
Olson, M
McCormack, RT
Wians, FH
Keffer, JH
Duh, SH
机构
[1] Univ Maryland, Sch Med, Dept Pathol, Baltimore, MD 21201 USA
[2] Univ Maryland, Sch Med, Dept Med & Res Technol, Baltimore, MD 21201 USA
[3] Hennepin Cty Med Ctr, Dept Lab Med & Pathol, Minneapolis, MN 55415 USA
[4] Univ Texas, SW Med Ctr, Dallas, TX 75235 USA
[5] Beckman Instruments Inc, Chaska, MN 55318 USA
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中图分类号
R446 [实验室诊断]; R-33 [实验医学、医学实验];
学科分类号
1001 ;
摘要
We evaluated the ACCESS(R) 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 mu g/L, and the limit of quantitation was 0.046 mu g/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 mu g/L (r = 0.811). Fifty-nine of 61 ambulatory patients without cardiac symptoms had no detectable cTnI (95% range, 0.00 to 0.025 mu g/L). The optimum cutoff for discriminating MI (n = 289, 45 with MI) was 0.15 mu g/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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页码:52 / 60
页数:9
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