We determined factor VII antigen (FVIIag) levels in 705 healthy blood
donors ranging in age from 17 to 79 years using a two-site solid-phase
enzyme immunoassay developed in our laboratory. The mean (+/- SD) FVI
Iag level for the total population was 102 +/- 31%. FVIIag levels for
men (n = 375) and women (n = 330) were 101 +/- 28% and 103 +/- 33%, re
spectively. A significant increase in FVIIag was observed with age in
both men (r = 0.25, p <0.0001) and women (r = 0.35, p <0.0001). FVIIag
levels were significantly higher in women >60 years when compared to
men (median women: 125%; median men: 111%; p <0.05). On a subset of th
e study group (n = 45), FVIIag levels were correlated to total cholest
erol (r = 0.27, p = 0.08) and triglyceride (r = 0.41,p <0.01). Assumin
g the commonly used reference interval of 60-140% for FVII, the freque
ncies of FVIIag values for <60% and >140% using our assay were 2.1% an
d 9.2%, respectively. Gender and age-related differences in FVIIag lev
els must be considered in a reference interval. We further suggest tha
t assay-specific reference ranges be established, which may include va
lues outside the commonly used values of 60-140%.