ArticleFrontiers in medicine2026
Evaluation of cytokine analytical performance and optimization of quality control strategies using the six sigma model: a multicenter study.
Article in Frontiers in medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Background: The six sigma model is widely applied in laboratory quality management. This study used total allowable error (TEa) based on National Center for Clinical Laboratories (NCCL) external quality assessment (EQA) criteria and "desirable" biological variation (BV) specifications as quality goals to evaluate the analytical performance of 12 cytokines in five laboratories and develop individualized quality control (QC) strategies. Methods: Imprecision and trueness data for 12 cytokine assays were collected from five laboratories and used to calculate sigma metrics. Assay performance was visualized using a normalized sigma method decision chart. The Westgard sigma rules run-size flowchart and quality goal index (QGI) were further applied to design customized QC protocols and identify priority areas for improvement. Results: Sigma metrics varied by concentration level, with higher-concentration materials generally yielding better sigma performance. For the same analyte, sigma values also differed according to the selected quality goal. Compared with "desirable" BV specifications, NCCL criteria produced lower sigma values for interleukin-6 (IL-6), whereas interferon- Conclusion: The six sigma model provides a practical framework for cytokine assays quality management, supporting targeted QC design and focused analytical performance improvement.
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