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Clinical Chemistry 45: 1789-1796, 1999;
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(Clinical Chemistry. 1999;45:1789-1796.)
© 1999 American Association for Clinical Chemistry, Inc.


Articles

Evaluation of a Rapid Whole Blood ELISA for Quantification of Troponin I in Patients with Acute Chest Pain

Christopher Heeschen1,a, Britta U. Goldmann2, Lukas Langenbrink2, Guido Matschuck2 and Christian W. Hamm3

1 Stanford University Medical School, Department of Cardiovascular Medicine, Stanford, CA 94305-5406.

2 University Hospital Eppendorf, Department of Cardiology, 20246 Hamburg, Germany.

3 Kerckhoff-Clinic, Department of Cardiology, 61231 Bad Nauheim, Germany.
a Author for correspondence. Fax 650-725-1599; e-mail heeschen{at}stanford.edu

Background: Troponin I (cTnI) provides important prognostic information in patients with chest pain. We wished to evaluate a rapid, whole-blood analyzer for quantitative point-of-care testing.

Methods: A quantitative point-of-care test system (Stratus CS®; Dade-Behring) for cTnI with an incorporated centrifuge was evaluated in 412 patients with chest pain less than 12 h.

Results: Results were available within 15 min. CVs were 4.5% at 0.1 µg/L, 4.2% at 0.25 µg/L, and 6.5% at 0.82 µg/L. The detection limit was 0.01 µg/L. The 97.5% percentile in a healthy population was 0.08 µg/L. Based on ROC curve analysis, a threshold of 0.15 µg/L was calculated for the detection of acute myocardial infarction (AMI). With it, sensitivity for the detection of patients with AMI (n = 62) was 63% at arrival and 98% after 4 h (Stratus II®, 48% and 85%, respectively; P <0.01). In 42% of patients with unstable angina (n = 121), cTnI was >=0.08 µg/L (Stratus II, 28%; P <0.01). During 30 days, death or AMI occurred in 25.5% of these cTnI-positive vs 2.9% of cTnI-negative patients (Stratus II, 29.4% vs 5.8%).

Conclusion: The Stratus CS provided better analytical performance and comparable or better prognostic information than the Stratus II.




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