Analytical and clinical evaluation of two homogeneous assays for LDL-cholesterol in hyperlipidemic patients.
BACKGROUND
LDL-cholesterol (LDL-C) concentrations are the primary basis for treatment guidelines established for hyperlipidemic patients. LDL-C concentrations are commonly monitored by means of the Friedewald formula, which provides a relative estimation of LDL-C concentration when the triglyceride concentration is <2000 mg/L and there are no abnormal lipids. The Friedewald formula has several limitations and may not meet the current total error requirement of <12% in LDL-C measurements.


METHODS
We evaluated the analytical and clinical performance of two direct methods (Roche and Wako) by analyzing 313 fresh serum samples obtained from dyslipidemic patients in a lipid clinic and comparing them with modified beta-quantification.


RESULTS
Both homogeneous assays displayed excellent precision (CV <2%). The Roche method showed a mean total error of 7.72%, and the Wako method showed a mean total error of 4.46% over a wide range of LDL-C concentrations. The Roche method correlated highly with the modified beta-quantification assay (r = 0.929; y = 1.052x - 168 mg/L; n = 166) and showed a bias of -4. 5% as a result of the assigned standard value. The Wako method also correlated highly with beta-quantification (r = 0.966; y = 0.9125x + 104.8 mg/L; n = 145) without significant bias. The Roche method correctly classified 97% of patients with triglycerides <2000 mg/L, 75% of patients with type IIb hyperlipemia (HPL), and 84% of patients with type IV HPL based on the cutpoints of 1300 and 1600 mg/L, compared with 98%, 78.4%, and 89%, respectively, for the Wako method. In dysbetalipoproteinemic patients, both methods have a 30% mean positive bias compared with beta-quantification.


CONCLUSIONS
Both direct methods can be a useful alternative when ultracentrifugation is not available for the diagnosis and control of lipid-lowering medication for patients with mixed HPL, but not for patients with type III hyperlipidemia.
Department of Biochemistry, Hospital de Galdakao, 48960 Vizcaya, Spain. mesteban@hgda.osakidetza.net
M
M
Esteban-Salán
A
A
Guimón-Bardesi
J M
JM
de La Viuda-Unzueta
M N
MN
Azcarate-Ania
P
P
Pascual-Usandizaga
E
E
Amoroto-Del-Río
D000328:Adult; D000368:Aged; D008078:Cholesterol, LDL / Q000097:blood*; D006801:Humans; D006949:Hyperlipidemias / Q000097:blood*; D006952:Hyperlipoproteinemia Type III / Q000097:blood; D008875:Middle Aged; D010772:Phosphotungstic Acid; D011933:Reagent Kits, Diagnostic; D014461:Ultracentrifugation
D008078:Cholesterol, LDL; D011933:Reagent Kits, Diagnostic; D010772:Phosphotungstic Acid