High sensitivity C-reactive protein: biological variations and reference limits.

Serum C-reactive protein (CRP) concentration was determined for 3605 subjects using an immunonephelometric assay improved to provide greater sensitivity. Subjects were from 5 to 75 years old and belonging to 1003 nuclear families recruited from the Stanislas Cohort Study between January 1994 and August 1995. Sample values for CRP ranged from 0.17 mg/l to 100 mg/l. Geometric means (mean - SD; mean +/- SD) were in the 5-14 years old group 0.37 (0.17-1.07) mg/l, in the 15-28 years old group 0.47 (0.17-1.38) mg/l and in the 29-75 years old group 0.98 (0.34-2.85) mg/l. For women, the geometric means were 0.38 (0.17-1.10) mg/l, 0.62 (0.20-1.90) mg/l and 0.98 mg/l (0.31-3.13) mg/l respectively. The interindividual variability ranged from 138% to 759% among different age classes. Biological factors associated with CRP concentration variations were examined and accounted for 25% of the CRP variability in men and 40% in women. The main biological factors statistically associated with CRP concentration variations in men were: drugs, leukocyte count, body mass index, tobacco consumption, age, and in women: drugs, leukocyte count, age, body mass index and hemoglobin concentration. These factors were used to define the exclusion and partition criteria when obtaining the reference samples. Medians for reference values ranged from 0.20 to 0.68 mg/l in males and from 0.20 to 0.78 mg/l in women.