Open Access

Priyanka Nagabhushana, Cyrill Rütsche, Christos Nakas, Alexander B. Leichtle

• Clinical laboratories frequently conduct method verification studies to ensure that the process meets quality standards for its intended use, such as patient testing. They play a pivotal role in healthcare, but issues such as accurate statistical assessment and reporting of verification data often make these studies challenging. Missteps can lead to false conclusions about method performance, risking patient safety or leading to incorrect diagnoses. Despite a requirement for accredited labs to document method performance, existing solutions are often expensive and complex. Addressing these issues, we present Method Verification-Graphical User Interface (MV-GUI), a software package designed for ease of use. It is platform-independent, capable of statistical analysis, and generates accreditation-ready reports swiftly and efficiently. Users can input patient data from one or more .CSV files, and MV-GUI will produce comprehensive reports, including statistical comparison tables, regressionClinical laboratories frequently conduct method verification studies to ensure that the process meets quality standards for its intended use, such as patient testing. They play a pivotal role in healthcare, but issues such as accurate statistical assessment and reporting of verification data often make these studies challenging. Missteps can lead to false conclusions about method performance, risking patient safety or leading to incorrect diagnoses. Despite a requirement for accredited labs to document method performance, existing solutions are often expensive and complex. Addressing these issues, we present Method Verification-Graphical User Interface (MV-GUI), a software package designed for ease of use. It is platform-independent, capable of statistical analysis, and generates accreditation-ready reports swiftly and efficiently. Users can input patient data from one or more .CSV files, and MV-GUI will produce comprehensive reports, including statistical comparison tables, regression plots, and Bland–Altman plots. While method validation, which establishes the performance of new diagnostic tools, remains a crucial concern for manufacturers, MV-GUI primarily streamlines the method verification process. The software aids both medical practitioners and researchers and is designed to be user-friendly, even for non-experienced users. Requiring no internet connection, MV-GUI can operate in restricted IT environments, making method verification widely accessible and efficient.…