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APS calculator: a data-driven tool for setting outcome-based analytical performance specifications for measurement
Hikmet Can Çubukçu1,2, Florent Vanstapel3,4, Marc Thelen5,6
1General Directorate of Health Services, Rare Diseases Department, Turkish Ministry of Health, Ankara, Türkiye.
Laboratory professionals can now calculate analytical performance specifications (APS) for measurement uncertainty (MU) using a new web application. This tool simulates the impact of MU on patient care outcomes based on user-defined limits and population data.
Area of Science:
- Clinical Chemistry
- Laboratory Medicine
- Metrology
Background:
- ISO 15189:2022 mandates that analytical performance specifications (APS) align with clinical utility and patient care impact.
- Quantifying the influence of measurement uncertainty (MU) on clinical decisions is crucial for establishing appropriate APS.
Purpose of the Study:
- To develop a web application enabling laboratory professionals to calculate APS for MU.
- To simulate the impact of MU on clinical outcomes using user-defined decision limits and agreement thresholds.
Main Methods:
- Developed the "APS Calculator" web application for data upload, parameter specification, and simulation.
- Simulated measurand concentrations with varying MU, assessed agreement with clinical decision limits, and determined acceptable MU based on user-defined thresholds.
- Utilized National Health and Nutrition Examination Survey data and relevant guideline decision limits for application testing.
Main Results:
- Successfully determined APS for MU for six key measurands, including hemoglobin, glucose, cholesterol, triglycerides, and folate.
- Demonstrated the application's capability to generate data-driven APS tailored to specific clinical contexts.
Conclusions:
- The "APS Calculator" provides a flexible, data-driven tool for laboratory professionals to establish APS for MU.
- This application facilitates the calculation of APS aligned with intended clinical use and population-specific data.
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