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See detailApplication of the characteristic function to evaluate and compare analytical variability in an external quality assessment scheme for serum ethanol
Coucke, Wim; Charlier, Corinne ULg; Lambert, Willy et al

in Clinical Chemistry (2015), 61

As a cornerstone of quality management in the laboratory, External Quality Assessment (EQA) schemes are used to assess laboratory and analytical method performance. The characteristic function is used to ... [more ▼]

As a cornerstone of quality management in the laboratory, External Quality Assessment (EQA) schemes are used to assess laboratory and analytical method performance. The characteristic function is used to describe the relation between the target concentration and the EQA standard deviation, which is an essential part of the evaluation process. The characteristic function is also used to compare the variability of different analytical methods. We fitted the characteristic function to data from the Belgian External Quality Assessment program for serum ethanol. Data included results from headspace gas chromatography and the enzymatic methods of Abbott, Roche, Siemens, and Ortho-Clinical Diagnostics. We estimated the characteristic function with weighted nonlinear regression. By introducing dummy variables, we rewrote the original formula of the characteristic function to assess statistical inference for comparing the variability of the different analytical methods. The characteristic function fitted the data precisely. Comparison between methods showed that there was little difference between the estimated variability for low concentrations, and that the increase in SD with increasing target concentration was slower for Abbott and Roche than for the other methods. The characteristic function can successfully be introduced in clinical schemes, although its applicability to fit the data should always be assessed. Because of its easy parameterization, it can be used to assess differences in performance between analytical methods and to assess laboratory performance. The characteristic function also offers an alternative framework for coefficients of variation to describe variability of analytical methods. [less ▲]

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See detailComparison of different approaches to evaluate External Quality Assessment Data.
Coucke, Wim; China, Bernard; Delattre, Isabelle et al

in Clinica Chimica Acta (2012), 413(5-6), 582-6

In EQA programs, Z-scores are used to evaluate laboratory performance. They should indicate poorly performing laboratories, regardless of the presence of outliers. For this, two different types of ... [more ▼]

In EQA programs, Z-scores are used to evaluate laboratory performance. They should indicate poorly performing laboratories, regardless of the presence of outliers. For this, two different types of approaches exist. The first type are "outlier-based" approaches, which first exclude outlying values, calculate the average and standard deviation on the remaining data and obtain Z-scores for all values (e.g., Grubbs and Dixon). The second type includes the "robust" approaches (e.g., Tukey and Qn or the algorithm recommended by ISO). The different approaches were assessed by randomly generated samples from the Normal and Student t distributions. Part of the sample data were contaminated with outliers. The number of false and true outliers was recorded and subsequently, Positive and Negative Predictive Values were derived. Also, the sampling mean and variability were calculated for location and scale estimators. The various approaches performed similarly for sample sizes above 10 and when outliers were at good distance from the centre. For smaller sample sizes and closer outliers, however, the approaches performed quite differently. Tukey's method was characterised by a high true and a high false outlier rate, while the ISO and Qn approaches demonstrated weak performance. Grubbs test yielded overall the best results. [less ▲]

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See detailA new statistical method for evaluating long-term analytical performance of laboratories applied to an external quality assessment scheme for flow cytometry.
Coucke, Wim; Van Blerk, Marjan; Libeer, Jean*-Claude et al

in Clinical Chemistry & Laboratory Medicine (2010), 48(5), 645-50

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 ... [more ▼]

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. [less ▲]

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See detailCurrent practices in antinuclear antibody testing: results from the Belgian External Quality Assessment Scheme.
Van Blerk, Marjan; Van Campenhout, Christel; Bossuyt, Xavier et al

in Clinical Chemistry & Laboratory Medicine (2009), 47(1), 102-8

BACKGROUND: This study aimed to assess the state-of-the-art of antinuclear antibody (ANA) testing as practiced in the Belgian and Luxembourg laboratories, using the results obtained in the Belgian ... [more ▼]

BACKGROUND: This study aimed to assess the state-of-the-art of antinuclear antibody (ANA) testing as practiced in the Belgian and Luxembourg laboratories, using the results obtained in the Belgian National External Quality Assessment Scheme from 2000 to 2005. METHODS: During this period, nine samples with different specificities were sent for analysis. Participants were surveyed for methodology used and were asked to report staining pattern and titer of ANAs. In 2002, an attempt was made to improve the comparability of quantitative ANA results by the provision of a commercial reference material and to relate observed differences to methodology. RESULTS: With one exception, all participants employed a microscope-based indirect immunofluorescence assay with human epithelial cell line 2 cells. Most laboratories were accurate in describing the pattern. The percentage of unacceptable answers was greater for samples with borderline levels of antibody and for samples showing a cytoplasmic pattern. An improvement in the detection of anticentromere antibodies was observed. For all samples, a wide range of titers was reported. The provision of the secondary reference preparation led to improved inter-laboratory concordance. Comparison of methodology variables revealed a correlation between unstandardized titers and the power of the lamp of the microscope and the use of a dark room. CONCLUSIONS: The EQAS results presented in this work provide valuable insights into the state of the art of ANA testing as practiced in the Belgian and Luxembourg Laboratories and illustrate the important value of a national EQAS for ANA testing as a tool to improve performance and interlaboratory comparability of laboratory results. [less ▲]

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