OBJECTIVE - To assess the accuracy of plasma LDL cholesterol concentra
tions estimated by the Friedewald formula and a direct immunoseparatio
n method by comparison with a reference ultracentrifugation procedure
in patients with diabetes. RESEARCH DESIGN AND METHODS - Fasting plasm
a samples with triglyceride concentrations <4.5 mmol/l were collected
from 100 patients with diabetes (28 type I and 72 type II) and LDL cho
lesterol concentrations were compared by the three methods. RESULTS -
LDL cholesterol values determined by the reference beta-quantitation p
rocedure were highly correlated with both the Friedewald formula (r =
0.96) and a direct immunoseparation method (r = 0.92). Calculated (Fri
edewald) LDL cholesterol coincided with the reference method with <10%
error in 74% of the total diabetic group (82% of type I and 68% of ty
pe II diabetic patients). However, agreement between the direct LDL ch
olesterol and reference methods was significantly less (P = 0.02), wit
h only 44% of patients having an error of <10% (52% of type I and 41%
of type II diabetic patients). The direct immunoseparation method for
LDL cholesterol showed a positive bias with increasing triglyceride co
ncentrations, particularly for patients with type II diabetes. CONCLUS
IONS - In the group of diabetic patients studied with plasma triglycer
ide concentrations <4.5 mmol/l, the Friedewald formula provided an acc
urate estimation of LDL cholesterol. The direct immunoseparation metho
d significantly overestimated LDL cholesterol at triglyceride levels b
etween 2 and 4.5 mmol/l.