ArticleJournal of clinical laboratory analysis2021
Practical application of Westgard Sigma rules with run size in analytical biochemistry processes in clinical settings.
Article in Journal of clinical laboratory analysis, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
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Who cites it
6 citing papers in PubMed.
- Quantitative measurement of anti-interferon-gamma autoantibodies for routine laboratory implementation.iScience · 2026Article
- 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
- [Quality Management for Biomonitoring of Smoking Harmful Effects].Jugan geon-gang gwa jilbyeong · 2024Article
- An assessment of analytical performance using the six sigma scale in second-trimester maternal prenatal screening practices in China.Practical laboratory medicine · 2024Article
- Application of a six sigma model to evaluate the analytical performance of urinary biochemical analytes and design a risk-based statistical quality control strategy for these assays: A multicenter study.Journal of clinical laboratory analysis · 2021Article
- Practical application of Westgard Sigma rules with run size in analytical biochemistry processes in clinical settings.Journal of clinical laboratory analysis · 2021Article
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Authors and funding
5 authors.
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Abstract
backgroundThe performance of 18 routine chemical detection methods was evaluated by the sigma (σ) metric, and Westgard Sigma rules with run size were used to establish internal quality control (IQC) standards to reduce patient risks. MATERIALS AND
methodsExternal quality assessment (EQA) and internal quality control data from 18 assays in a biochemical laboratory were collected from January to June 2020. The sigma values of each assay were calculated, based on the bias, total error allowable, and coefficient of variation, appropriate quality control rules were selected. According to the quality goal index, the main causes of poor performance were determined to guide quality improvement.
resultsAt IQC material level 1, seven of the 18 assays achieved five sigma (excellent), and five assays (UA, Crea, AMY, TC and Na) showed world-class performance. At IQC material level 2, 14 of the 18 assays achieved 5 sigma (excellent), and thirteen assays (UA, ALT, CK, Crea, AMY, K, AST, ALP, Na, LDH, Mg, TC and GGT) showed world-class performance. The quality goal index (QGI) was calculated for items with analysis performance <5 sigma, and the main causes of poor performance were determined to guide quality improvement.
conclusionsWestgard sigma rules with run size are an effective tool for evaluating the performance of biochemical assays. These rules can be used to more simply and intuitively select the quality control strategy of related items and reduce the risk to patients.
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