Optimization and validation of moving average quality control procedures using bias detection curves and moving average validation charts
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Huub H. van Rossum
und
Hans Kemperman
Abstract
Background:
To date, no practical tools are available to obtain optimal settings for moving average (MA) as a continuous analytical quality control instrument. Also, there is no knowledge of the true bias detection properties of applied MA. We describe the use of bias detection curves for MA optimization and MA validation charts for validation of MA.
Methods:
MA optimization was performed on a data set of previously obtained consecutive assay results. Bias introduction and MA bias detection were simulated for multiple MA procedures (combination of truncation limits, calculation algorithms and control limits) and performed for various biases. Bias detection curves were generated by plotting the median number of test results needed for bias detection against the simulated introduced bias. In MA validation charts the minimum, median, and maximum numbers of assay results required for MA bias detection are shown for various bias. Their use was demonstrated for sodium, potassium, and albumin.
Results:
Bias detection curves allowed optimization of MA settings by graphical comparison of bias detection properties of multiple MA. The optimal MA was selected based on the bias detection characteristics obtained. MA validation charts were generated for selected optimal MA and provided insight into the range of results required for MA bias detection.
Conclusions:
Bias detection curves and MA validation charts are useful tools for optimization and validation of MA procedures.
Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Research funding: None declared.
Employment or leadership: H.H. van Rossum is registered as inventor on a filed patent describing the content of the manuscript. H.H. van Rossum is owner and director of Huvaros BV company that holds an exclusive license of the intellectual property described.
Honorarium: None declared.
Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.
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©2017 Walter de Gruyter GmbH, Berlin/Boston
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- Frontmatter
- Editorial
- Commutable samples with assigned target concentrations may help us harmonise general chemistry results
- Reviews
- Performance of point-of-care HbA1c test devices: implications for use in clinical practice – a systematic review and meta-analysis
- Cardiac troponins and mortality in type 1 and 2 myocardial infarction
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- Genetics and Molecular Diagnostics
- External quality assessment for human papillomavirus 16/18 DNA detection and genotyping in Shanghai, China
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- Analytical performance of 17 general chemistry analytes across countries and across manufacturers in the INPUtS project of EQA organizers in Italy, the Netherlands, Portugal, United Kingdom and Spain
- Commutability of proficiency testing material containing tobramycin: a study within the framework of the Dutch Calibration 2.000 project
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- Smart management of sample dilution using an artificial neural network to achieve streamlined processes and saving resources: the automated nephelometric testing of serum free light chain as case study
- An integrated proteomic and peptidomic assessment of the normal human urinome
- An alternative inhibition method for determining cross-reactive allergens
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- Cancer Diagnostics
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- Cardiovascular Diseases
- Mid-regional pro-adrenomedullin (MR-proADM) and mid-regional pro-atrial natriuretic peptide (MR-proANP) in severe aortic valve stenosis: association with outcome after transcatheter aortic valve implantation (TAVI)
- Association between apolipoprotein E polymorphisms and premature coronary artery disease: a meta-analysis
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- CT or MRI
- Reply to: CT or MRI in the diagnosis of right lower quadrant abdominal pain?
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- Glycated albumin: correlation to HbA1c and preliminary reference interval evaluation
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