Abstract
Abstract Introduction Clinical chemistry assays are responsible for 57% of all core lab testing (1) as a result there is an ever-increasing demand to improve the accuracy and reliability of results in clinical laboratories. Sigma metrics have proven to be powerful tools for quantitatively evaluating clinical assay and instrument performance. The Sigma performance of an assay is calculated from the formula (TEa-Bias)/CV. To address modern clinical laboratory performance requirements Abbott has developed and launched a portfolio of clinical chemistry assays under the brand name Sigma STRONG ™ which claim to achieve world class performance with a Sigma Metric of ≥6 for 86% of products within this portfolio (2). The purpose of this study is to assess these assays against Abbott’s products requirement (PR) for precision and method comparison. Methods Assay precision (%CV) studies were performed based on guidance from CLSI EP05-A3 using 2–3 levels of commercially available serum-based control material. Method Comparison (MC) studies were performed based on guidance from CLSI EP09-A3 using the Passing-Bablok regression method. Assays under investigation were assessed for performance on either the Abbott Alinity c or Abbott ARCHITECT c systems. Results Conclusion This study has confirmed the sigma STRONG ™ assays, under assessment, have met Abbott’s product requirement for both precision and method comparison.
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