ArticleBiochemia medica2018
Application of Sigma metrics in assessing the clinical performance of verified
Article in Biochemia medica, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
8 citing papers in PubMed, 13 citations in OpenAlex.
- Bias in Laboratory Medicine: The Dark Side of the Moon.Annals of laboratory medicine · 2024Review
- 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
- Internal Quality Control Data of Urine Reagent Strip Tests and Derivation of Control Rules Based on Sigma Metrics.Annals of laboratory medicine · 2021Article
- Sigma metrics application for validated and non-validated detecting systems performance assessment.Journal of clinical laboratory analysis · 2021Article
- Evaluation of the analytical performance of endocrine analytes using sigma metrics.Journal of clinical laboratory analysis · 2021Article
- Assessment of quality control system by sigma metrics and quality goal index ratio: A roadmap towards preparation for NABL.World journal of methodology · 2018Article
- Special issue on Six Sigma metrics - experiences and recommendations.Biochemia medica · 2018Article
Corrections and comments
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Authors and funding
2 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionSigma metrics analysis is considered an objective method to evaluate the performance of a new measurement system. This study was designed to assess the analytical performance of verified MATERIALS AND
methodsThe coefficient of variation (CV) was calculated according to the mean and standard deviation (SD) derived from the internal quality control for 20 consecutive days. The data were measured on an Architect c16000 analyser with reagents from four manufacturers. Commercial reference materials were used to estimate the bias. Total allowable error (TEa) was based on the CLIA 1988 guidelines. Sigma metrics were calculated in terms of CV, percent bias and TEa. Normalized method decisions charts were built by plotting the normalized bias (bias
resultsThe reagents were compared between different manufacturers in terms of the Sigma metrics for relevant analytes. Abbott and Leadman's verified reagents provided better Sigma metrics for the alanine aminotransferase assay than non-verified reagents (Mindray and Zybio). All reagents performed well for the aspartate aminotransferase and uric acid assays with a sigma of 5 or higher. Abbott achieved the best performance for the urea assay, evidenced by the sigma of 2.83 higher than all reagents, which were below 1-sigma.
conclusionSigma metrics analysis system is helpful for clarifying the performance of candidate non-verified reagents in clinical laboratory. Our study suggests that the quality of non-verified reagents should be assessed strictly.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.