ArticleBiochemia medica2022
Evaluation of the clinical chemistry tests analytical performance with Sigma Metric by using different quality specifications - Comparison of analyser actual performance with manufacturer data.
Article in Biochemia medica, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
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Who cites it
8 citing papers in PubMed.
- A comparative study of sigma metrics and statistical quality control rules in clinical biochemistry laboratories using a Cobas pure analyzer.Journal of family medicine and primary care · 2026Article
- Six SIGMA-based quality assessment of biochemical analytes: A comparative analysis of clinical laboratory improvement amendments 1988 and 2024 standards.Journal of medical biochemistry · 2025Article
- Analytical performance evaluation of a new integrated clinical chemistry and immunoassay analyzer.Practical laboratory medicine · 2024Article
- Evaluation of Coefficients of Variation for Clinical Chemistry Tests Based on Internal Quality Control Data Across 5,425 Laboratories in China From 2013 to 2022.Annals of laboratory medicine · 2024Article
- Bias in Laboratory Medicine: The Dark Side of the Moon.Annals of laboratory medicine · 2024Review
- Analysis of biochemical analytes using six sigma metrics with two analyzers at an Indian lab setting.Bioinformation · 2023Article
- Bias estimation for Sigma metric calculation: arithmetic meanBiochemia medica · 2022Article
- Bias, the unfinished symphony.Biochemia medica · 2022Article
Corrections and comments
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Authors and funding
1 author.
Funding
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Abstract
introductionThe interest in quality management tools/methodologies is gradually increasing to ensure quality and accurate results in line with international standards in clinical laboratories. Six Sigma stands apart from other methodologies with its total quality management system approach. However, the lack of standardization in tolerance limits restricts the advantages for the process. Our study aimed both to evaluate the applicability of analytical quality goals with Roche Cobas c 702 analyser and to determine achievable goals specific to the analyser used. MATERIALS AND
methodsThe study examined under two main headings as Sigma
resultsConsidering the total number of targets achieved, Sigma
conclusionsThe balance between the applicability and analytical assurance of "goal-setting models" should be well established. Even if the package insert data provided by the manufacturer were used in our study, it was observed that almost a quarter of the evaluated analytes failed to achieve even "acceptable" level performance according to BV-based goals. Therefore, "state-of-the-art" goals for the Six Sigma methodology are considered to be more reasonable, achievable, and compatible with today's technologies.
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