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Clinical Chemistry 56: 781-788, 2010. First published March 26, 2010; 10.1373/clinchem.2009.138347
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(Clinical Chemistry. 2010;56:781-788.)
© 2010 American Association for Clinical Chemistry, Inc.

Lipids, Lipoproteins, and Cardiovascular Risk Factors

{gamma}' Fibrinogen: Evaluation of a New Assay for Study of Associations with Cardiovascular Disease

Rehana S. Lovely1, Steven C. Kazmierczak2, Joseph M. Massaro3, Ralph B. D'Agostino, Sr.4, Christopher J. O'Donnell5 and David H. Farrell2,a

1 Department of Biomedical Sciences, Missouri State University, Springfield, MO; 2 Department of Pathology, Oregon Health & Science University, Portland, OR; 3 Department of Biostatistics, Boston University School of Public Health, Boston, MA; 4 Mathematics and Statistics Department, Boston University, Boston, MA; 5 Cardiology Division, Massachusetts General Hospital, Boston, MA, and the National Heart, Lung, and Blood Institute’s Framingham Heart Study, Framingham, MA.

aAddress correspondence to this author at: Department of Pathology, L113, Oregon Health & Science University, 3181 S.W. Sam Jackson Park Rd., Portland, OR 97239-3098. Fax 503-494-2025; e-mail farrelld{at}ohsu.edu.

Background: Studies of disease associations with {gamma}' fibrinogen, a newly emerging risk factor for cardiovascular disease, have been hampered by the lack of a standardized and well-characterized assay.

Methods: We developed an immunometric technique to measure {gamma}' fibrinogen concentrations in plasma and studied the clinical utility of this test in samples from healthy individuals enrolled in the Framingham Offspring Study and in a separate case/control study of coronary artery disease (CAD). Monoclonal antibody 2.G2.H9, specific for the unique carboxyl terminal peptide of the fibrinogen {gamma}' chain, was used as capture antibody. Sheep antihuman fibrinogen/horseradish peroxidase conjugate was used for detection, with 3,3',5,5'-tetramethylbenzidine as substrate. We evaluated the linearity, imprecision, analytical specificity, and lower limit of quantification of the assay. We determined the reference interval for {gamma}' fibrinogen in healthy individuals from the Framingham Offspring Study (n = 2879) and quantified associations between {gamma}' fibrinogen and cardiovascular disease risk factors. The sensitivity and specificity of {gamma}' fibrinogen in evaluating CAD patients (n = 133) was determined with ROC curve analysis.

Results: The {gamma}' fibrinogen ELISA had within-run CVs of 13.4% at 0.127 g/L and 4.8% at 0.416 g/L. The limit of quantification at an imprecision of 20% was 0.10 g/L. The reference interval for healthy individuals was 0.088–0.551 g/L. ROC curve analysis of results from patients with CAD yielded an area under the curve of 0.76, with a diagnostic accuracy of 0.78 at a decision threshold of 0.30 g/L.

Conclusions: {gamma}' Fibrinogen shows excellent utility for cardiovascular risk analysis.




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Fibrinogen Assays for Cardiovascular Risk Assessment
Clin. Chem., May 1, 2010; 56(5): 693 - 695.
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