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Background: A number of methods have been developed to measure small dense low-density lipoprotein cholesterol (sd-LDL-C) to evaluate atherogenic risk in the population. However, to our knowledge there are no reports about the biologic variability of these lipoproteins. Therefore, the aim of this work was to estimate sd-LDL-C biological variability, and with this information establish quality specifications, index of individuality (II) and reference change values (RCV). Methods: To estimate within- and between-subject biological variability, sd-LDL-C in serum was measured in 24 individuals (11 female and 13 male) for 5 consecutive days and then, at 2 and 3 weeks. Quality specifications, II, and RCVs were estimated according to procedures described. Results: Total within- and between-subject biological variability, expressed as coefficient of variation, was 9.1% and 20%. Meanwhile, within- and between-biological variability in female and men was 10.9% and 6.7%, and 22% and 17%, respectively. Desirable quality specification to the sd-LDL-C method was 4.6% for analytical imprecision, bias 5.5% and total allowable error of 11.4%; the II was 0.46 and the RCV (calculated at 95% and 99% of significance) was 27.1% and 35.7%, for the total data. Conclusions: Short-term biological variability components were determined, and then used to estimate quality specifications, II and RCV for sd-LDL-C precipitation assay. To our knowledge, this is one of the first reports about sd-LDL-C biological variability, so that this information can be used as a starting point to develop long-term studies of biological variability for sd-LDL-C. [ABSTRACT FROM AUTHOR]

Hematologic parameters are commonly utilized in sports medicine and antidoping testing. However, there are no universally accepted methodologies for comparing the performance of automated blood analyzer systems. To address this problem, we selected and examined 19 studies from a review of literature published from 2000 to 2010. Meaningful discrepancies were found between measurements obtained with different analytical systems. Because harmonization and clear standardization of methods are lacking, the analytical variability often largely exceeds intra- and inter-individual biological differences, producing equivocal test results unreliable for clinical and antidoping testing. A central criticality to applying the Bayesian approach is analytical variability, but the use of different analytical technologies precludes the comparison of inter-methods for determining the robustness of blood variables and their clinical significance. Therefore, future multicenter studies are needed to compare analytical methodologies and blood analyzer systems, and to establish worldwide-accepted standards and quality control protocols. [ABSTRACT FROM AUTHOR]

Background: The Belgian External Quality Assessment Scheme for Flow Cytometry evaluates the long-term analytical performance of participating laboratories by calculating a regression line between the target and reported values of each parameter for each laboratory during the past 3 years. This study aims to develop a method to find laboratories with aberrant variability or bias using robust techniques and to obtain robust estimates of the variability. Methods: A method is proposed to find outliers with respect to the individual regression line, followed by a step to find regression lines with excessive variability and finally a step to find regression lines with high bias. Results: The model was applied to the results obtained by 52 laboratories for CD4%. From the 1340 data points, 35 were determined to be regression outliers. The second step revealed one regression line with excessive variability; the third step detected three regression lines with exceeding bias. Conclusions: The methodology allows assessment of the long-term performance of laboratories, taking into account samples with different target values. Outliers in the first step indicate accidental mistakes, outliers in the second and third step point to high analytical variability or bias. Clin Chem Lab Med 2010;48:645–50. [ABSTRACT FROM AUTHOR]

The Athletes Biological Passport (ABP) has received both criticisms and support during this year. In a recent issue of The Lancet, Michael Wozny considered that the use of the ABP makes it more difficult to take banned substances and that it was successfully used against the Italian elite cyclist Franco Pellizotti. After that, Italy's anti-doping tribunal considered that there was not enough evidence to prove manipulation of his own blood profile in Pellizotti's case. However, the UCI appealed to the Court of Arbitration for Sport (CAS) that sanctioned Pellizotti with a suspension of 2 years. Since its implementation, some problems have emerged. From 2010 to date, a large number of reports regarding the stability of the blood variables used to determine the ABP have been published, showing mixed results. This study considers that there is a risk of misinterpreting the physiological variations of the hematological parameters determined by the anti-doping authorities in the ABP. The analytical variability due to exercise training and competitions and/or to different metabolic energy demands, hypoxia treatments, etc. could lead to an increase in false-positives when using the ABP with the dramatic consequences that they might cause in major sports events like the forthcoming London Olympic Games. Moreover, the ABP characteristics, procedures, thresholds, or individual determination of reference ranges, abnormal out-comes, strikes, 'how the profile differs from what is expected in clean athletes' should be clearly stated and explained in a new public technical document to avoid misunderstandings and to promote transparency. [ABSTRACT FROM AUTHOR]

A letter to the editor is presented about physician's knowledge in relation to the variability of laboratory test results.