ArticleJournal of clinical laboratory analysis2019
Application of Six Sigma for evaluating the analytical quality of tumor marker assays.
Article in Journal of clinical laboratory analysis, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
What it found
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
6 citing papers in PubMed.
- Analytical performance evaluation of intelligent quality management of blood gas analyzer.Practical laboratory medicine · 2025Article
- The application of sigma metrics in the laboratory to assess quality control processes in South Africa.African journal of laboratory medicine · 2022Article
- Application of Sigma metrics in the quality control strategies of immunology and protein analytes.Journal of clinical laboratory analysis · 2021Article
- 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
- Evaluation of the analytical performance of endocrine analytes using sigma metrics.Journal of clinical laboratory analysis · 2021Article
- Application of Six Sigma for evaluating the analytical quality of tumor marker assays.Journal of clinical laboratory analysis · 2019Article
Corrections and comments
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Authors and funding
8 authors.
Funding
Abstract
contextThe results of detection assays for the same specimen are usually quite different in different laboratories or when tested with different detection systems.
objectiveThis study was designed to investigate the value of applying sigma metrics derived from different standards for allowable total error (TEa) in evaluating the analytical quality of tumor marker assays.
methodsAssays were evaluated for these six tumor markers: total prostate-specific antigen (tPSA), carcinoembryonic antigen (CEA), alpha-fetoprotein (AFP), carbohydrate antigen 199 (CA199), carbohydrate antigen 125 (CA125), and carbohydrate antigen 153 (CA153). Sigma values were calculated for two concentrations of quality control products to assess differences in quality of tumor marker assays. Improvement measures were recommended according to the quality goal index, and appropriate quality control rules were selected according to the sigma value.
resultsThe sigma value was highest using the higher biological variation-derived "appropriate" TEa standard: it was sigma ≥6 or higher in 16.7% of tumor markers. Sigma was below 6 for all tumor markers using the other three TEa. CEA, AFP, CA199, CA125, and CA153 required improved precision. The marker tPSA required improve precision and accuracy. According to sigma values by using China's external quality assessment standards, CEA, AFP, CA125, and CA153 require 1
conclusionSix Sigma is useful for evaluating performance of tumor markers assays and has important application value in the quality control of these assays.
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Registered trials
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