TY - JOUR
T1 - Multicentric evaluation of the homogeneous LDL-cholesterol Plus assay: Comparison with beta-quantification and Friedewald formula
AU - Esteban-Salan, Margarita
AU - Aguilar-Doreste, José Angel
AU - Arranz-Pena, Maria Luisa
AU - Juve-Cuxart, Santiago
AU - Gich-Salarich, Ignasi
AU - Zapico-Muniz, Edgar
AU - Ordonez-Llanos, Jordi
PY - 2008/11/1
Y1 - 2008/11/1
N2 - Objectives: To evaluate the analytical and clinical performance of a new version of the LDL-C Plus assay and compare it with the beta-quantification (BQ) method in a multicenter study. Design and methods: Direct LDL-C was measured in 169 fresh pooled samples and in 830 clinical samples with known LDL-C by BQ. The reactivity of lipoproteins and the effect of hemoglobin, bilirubin and chylomicrons (CM) were studied. Results: Direct LDL-C total imprecision was < 2.2%; inaccuracy < ± 2.5% (unaffected by triglycerides up to 9.5 mmol/L); and total error 9.8%. Direct assay reacted with 95%, 50% and 25% of the cholesterol in the LDL, intermediate (IDL) and VLDL fractions, respectively. A significant association was observed with BQ. Icteric samples showed a negative bias and the effect of CM was variable. A positive bias was observed when VLDL-cholesterol/triglyceride ratio was > 0.57. Conclusions: LDL-C Plus assay represents a valid alternative to BQ for clinical laboratories. © 2008 The Canadian Society of Clinical Chemists.
AB - Objectives: To evaluate the analytical and clinical performance of a new version of the LDL-C Plus assay and compare it with the beta-quantification (BQ) method in a multicenter study. Design and methods: Direct LDL-C was measured in 169 fresh pooled samples and in 830 clinical samples with known LDL-C by BQ. The reactivity of lipoproteins and the effect of hemoglobin, bilirubin and chylomicrons (CM) were studied. Results: Direct LDL-C total imprecision was < 2.2%; inaccuracy < ± 2.5% (unaffected by triglycerides up to 9.5 mmol/L); and total error 9.8%. Direct assay reacted with 95%, 50% and 25% of the cholesterol in the LDL, intermediate (IDL) and VLDL fractions, respectively. A significant association was observed with BQ. Icteric samples showed a negative bias and the effect of CM was variable. A positive bias was observed when VLDL-cholesterol/triglyceride ratio was > 0.57. Conclusions: LDL-C Plus assay represents a valid alternative to BQ for clinical laboratories. © 2008 The Canadian Society of Clinical Chemists.
KW - Direct method
KW - LDL-cholesterol
KW - Method comparison
U2 - 10.1016/j.clinbiochem.2008.07.014
DO - 10.1016/j.clinbiochem.2008.07.014
M3 - Article
SN - 0009-9120
VL - 41
SP - 1402
EP - 1409
JO - Clinical Biochemistry
JF - Clinical Biochemistry
IS - 16-17
ER -