International Journal of Science and Technology (IJST)

A Comprehensive Evaluation of the Accuracy and Precision of In Vitro Diagnostic Devices: Analytical Methodologies, Laboratory Influences, and Regulatory Considerations

In-vitro diagnostic (IVD) devices have been recognized as indispensable tools for disease detection, clinical monitoring, and therapeutic decision-making. Their diagnostic value is inherently dependent on the accuracy and precision of the results they produce. Accuracy is defined as the degree of conformity between a test result and the true or reference value, while precision refers to the consistency of repeated measurements under identical conditions. Inadequate performance in either metric may compromise clinical outcomes and patient safety. This review was undertaken to systematically evaluate the concepts, assessment methodologies, and regulatory standards related to the accuracy and precision of IVD devices. Emphasis was placed on laboratory-based evaluations to identify factors influencing diagnostic reliability. A comprehensive analysis of peer-reviewed literature and regulatory documents has revealed that multiple factors—including device design, reagent quality, operator handling, and environmental conditions—substantially impact accuracy and precision. Methodologies such as repeatability tests, inter-laboratory comparisons, and reference method comparisons were found to be essential for robust performance assessment. It was also observed that adherence to guidelines from regulatory bodies like the FDA, CLSI, and ISO improves diagnostic standardization. Moreover, calibration routines and quality control measures were shown to be critical in minimizing systematic and random errors. It was concluded that the assurance of diagnostic accuracy and precision requires a multidisciplinary approach encompassing engineering design, laboratory practices, and regulatory compliance. Future advancements in automation, sensor technology, and AI-driven analytics are expected to further enhance the performance and reliability of IVD devices.