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Clinical Chemistry
Year: 2010  |  Volume: 56  |  Issue: 5  |  Page No.: 781 - 788

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

R. S Lovely, S. C Kazmierczak, J. M Massaro, R. B D'Agostino, C. J O'Donnell and D. H. Farrell    


Background: Studies of disease associations with ' 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 ' 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 ' 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 ' fibrinogen in healthy individuals from the Framingham Offspring Study (n = 2879) and quantified associations between ' fibrinogen and cardiovascular disease risk factors. The sensitivity and specificity of ' fibrinogen in evaluating CAD patients (n = 133) was determined with ROC curve analysis.

Results: The ' 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: ' Fibrinogen shows excellent utility for cardiovascular risk analysis.

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