Professional Excel tool for comparability verification between quantitative methods and analyzers according to ISO 15189:2022 and CLSI EP09. Includes automatic calculation of bias, regression, correlation, Mean Bias (%), SD, R² and automatic PASS / FAIL interpretation. Ideal for accredited medical laboratories or laboratories preparing for accreditation.
This professional Excel tool was developed for medical laboratories that need to perform comparability verification between two quantitative analytical methods or two analyzers, according to ISO 15189:2022 requirements and CLSI EP09 recommendations.
The tool allows evaluation of analytical differences between two measurement systems using real patient samples and automatically generates the essential statistical parameters required for comparability assessment.
The Excel file is designed for practical use in accredited medical laboratories or laboratories preparing for accreditation and can be used both for internal verification studies and audit documentation.
This Excel tool can be used for:
After entering the results into the highlighted cells, the Excel file automatically calculates:
The file automatically compares Mean Bias (%) with the user-defined acceptance criterion and provides automatic interpretation:
The Excel file is clearly organized and intuitive:
The file is configured for:
Suitable for:
Eliminates manual calculations and significantly reduces the time required for comparability verification.
All statistical formulas are already implemented and verified.
Provides a uniform and reproducible approach for method comparison studies.
Can be used as supporting documentation for:
No additional statistical software is required.
Simply enter the results into the Excel file.
This product is intended for:
The package includes:
This tool was developed based on the following standards and recommendations:
By using this Excel tool, the laboratory can:
✔ fast and professional verification studies
✔ audit-ready documentation
✔ ISO 15189 compliant standardization
✔ reduced statistical calculation time
✔ automatic and clear interpretation
✔ simple implementation into daily laboratory practice
This Excel tool is intended exclusively for professional use by qualified laboratory personnel. The calculations and statistical interpretations provided by the file are designed to support method comparison and comparability verification activities in medical laboratories according to ISO 15189 and CLSI EP09 recommendations.
The final interpretation of results, acceptance criteria, and validation decisions remain the sole responsibility of the laboratory and its authorized personnel.
This product does not replace professional judgment, regulatory requirements, manufacturer instructions, or laboratory-specific procedures.
The author assumes no liability for decisions, actions, or consequences resulting from the use or misuse of this file.
Users are responsible for verifying the suitability of the tool for their specific laboratory applications and regulatory environment.
© Dr. Valeria Mureșan – All Rights Reserved.
This Excel tool, including its structure, formulas, statistical calculations, design, instructions, and accompanying materials, is protected by copyright law.
Unauthorized reproduction, redistribution, resale, modification, sharing, publication, or commercial use of this product, in whole or in part, is strictly prohibited without prior written permission from the author.
The purchase of this product grants a non-transferable license for use within a single laboratory or organization only.
For collaborations, institutional licenses, or distribution permissions, please contact Dr. Valeria Mureșan.