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Clinical Chemistry 0: clinchem.2005.064477v1, 2006; 10.1373/clinchem.2005.064477
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Received on ,
Accepted on ,

Technical Briefs

Influence of Imprecision on ROC Curve Analysis for Cardiac Markers

Peter Kupchak 1, Alan H.B. Wu 2*, Farooq Ghani 3, L. Kristen Newby 4, E. Magnus Ohman 4, Robert H. Christenson 5

1 Nanogen, Point of Care Diagnostics Division, Toronto, Ontario, Canada
2 Department of Laboratory Medicine, San Francisco General Hospital/University of California, San Francisco, CA
3 Bayer Healthcare Corporation, Tarrytown, NY
4 Department of Medicine, Division of Cardiology, Duke University Medical Center, Durham, NC
5 Department of Pathology, University of Maryland Medical Center, Baltimore, MD

* To whom correspondence should be addressed. E-mail: wualan{at}labmed2.ucsf.edu.

Background: There has been considerable debate regarding the impact of assay imprecision on the performance of cardiac biomarkers for diagnosis of acute coronary syndromes (ACS) and risk stratification for future adverse cardiac events.

Methods: Using existing data from 2 published clinical trials, we used a resampling methodology to statistically introduce 5%, 10%, and 20% imprecision to results for B-type natriuretic peptide (BNP) and cardiac troponin I (cTnI) and examined its impact on ROC curve analysis.

Results: Superimposition of artificial imprecision produced no significant difference in the area under the ROC curve observed for BNP for diagnosis of heart failure or for cTnI for 30-day risk stratification of patients with ACS.

Conclusion: Assay imprecision does not appear to be a critical determinant in the interpretation of cardiac marker results for patients with heart disease.


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