Multicentric evaluation of the homogeneous LDL-cholesterol Plus assay: comparison with beta-quantification and Friedewald formula.

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.

Multicentre physiological reference values for the concentration of creatininium in plasma and diagnostic specificity of glomerular filtration rate estimated with the MDRD equation.

BACKGROUND: The National Kidney Disease Education Program recommends that clinical laboratories, when asked for an estimation of glomerular filtration rate in a patient by means of the "four-variable" Modification of Diet in Renal Disease (MDRD) Study equation, also provide the measurement result for creatininium concentration in plasma and the appropriate reference interval. On the other hand, clinical laboratories seeking accreditation for compliance with ISO 15189:2003 need to demonstrate that the physiological reference intervals communicated to all users of laboratory services are appropriate for the patient population served, and for their measurement systems. METHODS: Ten clinical laboratories in different regions of Spain collaborated in identifying reference individuals and producing reference values for the concentration of creatininium in plasma using RD/Hitachi Modular Analytics analysers, and for the volume rate of glomerular filtrate in kidneys (glomerular filtration rate), estimated with the "four-variable" MDRD Study equation. All the logistic work was carried out in co-operation with the supplier of the reagents and analysers (Roche Diagnostics España, S.L., Sant Cugat del Vallès, Catalonia, Spain). Using all the reference values obtained by each laboratory, multicentre reference limits were estimated non-parametrically. RESULTS AND CONCLUSIONS: Reference intervals estimated in this study for concentrations of plasma creatininium are 52-85 micromol/L for women and 64-106 micromol/L for men. The diagnostic specificity of the estimated glomerular filtration rate is 99.2% when applied to healthy persons to screen for chronic kidney disease.

Multicentre physiological reference intervals for serum concentrations of immunoglobulins A, G and M, complement C3c and C4 measured with Tina-Quant reagents systems.

BACKGROUND: Clinical laboratories seeking accreditation for compliance with ISO 15189:2003 need to demonstrate that the physiological reference intervals communicated to all users of the laboratory service are appropriate for the patient population served and for the measurement systems used. In the case of immunological quantities, few articles have been published in peer-reviewed journals. METHODS: A total of 21 clinical laboratories in different regions of Spain collaborated in identifying reference individuals and determining adult reference intervals for some immunological quantities measured using RD/Hitachi Modular Analytics analysers and Tina-Quant reagent systems. These immunological quantities are the mass concentrations of immunoglobulin A, immunoglobulin G, immunoglobulin M, complement C3c and complement C4 in serum. All the logistic work was carried out in co-operation with the supplier of the reagents and analysers (Roche Diagnostics España, S.L., Sant Cugat del Vallès, Catalonia, Spain). From the set of reference values obtained by each laboratory, multicentre reference limits were estimated non-parametrically. RESULTS AND CONCLUSIONS: The reference intervals estimated in this study for concentrations of serum components under consideration are: complement C3c, 0.62-1.64 g/L for women and men; complement C4, 0.14-0.72 g/L for women and men; immunoglobulin A, 0.89-4.80 g/L for women and men; immunoglobulin G, 6.5-14.3 g/L for women and men; and immunoglobulin M, 0.48-3.38 g/L for women and 0.41-2.46 g/L for men.

Multicentre physiological reference values for some urinary component-to-creatinine (creatininium) concentration ratios.

Nine clinical laboratories in different regions of Spain have shared the search for reference individuals and the production of reference values for urinary component-to-creatininium concentration ratios measured in first morning urine samples using RD/Hitachi analysers. These urinary quantities include albumin, calcium(II), chloride, magnesium(II), phosphate, potassium ion, protein, sodium ion, urate and urea. All the logistic work was done in co-operation with the reagents' and analysers' supplier (Roche Diagnostics España, S.L., Sant Cugat del Vallès, Catalonia, Spain). From the blend of reference values obtained by each laboratory, the multicentre reference limits were estimated parametrically after mathematical transformation of original data.