Validation Procedures in Medical Laboratory Testing: A Systematic Review of Best Practices

Background: Validation procedures are essential in medical laboratory testing to ensure the accuracy and reliability of test results.
As laboratory technologies evolve, staying informed about the need for continuous updates and standardization of validation
practices is crucial. This knowledge keeps us at the forefront of high-quality diagnostic services and the latest advancements in
the field. Objectives: This systematic review aims to identify and synthesize best practices for validation procedures in medical
laboratory testing from 2010 to 2024, highlight common challenges, and provide recommendations for enhancing validation
protocols. Methods: A thorough literature search was conducted using PubMed, Scopus, and Web of Science databases for 31
studies published between 2010 and 2024. Studies on validation procedures for various medical laboratory tests, including
clinical chemistry, molecular diagnostics, immunoassays, and point-of-care testing, were included. Data were extracted and
analyzed to identify trends, standard practices, and gaps in existing validation protocols. Results: The review included 31 studies,
revealing several key findings: Standardization of validation protocols significantly improves the accuracy and reliability of
laboratory tests. This review focuses on the exciting potential of machine learning and advanced analytical techniques, which
have the power to enhance validation processes significantly. Emerging diagnostic technologies like next-generation sequencing
and liquid biopsy require rigorous validation to ensure clinical applicability, instilling a sense of caution and responsibility in the
audience. Our responsibility is to ensure that adequate quality control measures are in place. These measures are critical for
maintaining the integrity of point-of-care and rapid diagnostic tests. Compliance with regulatory requirements is crucial for
patient safety and effective validation practices. Conclusion: While robust validation procedures are vital for ensuring the
accuracy and reliability of medical laboratory tests, this review underscores the need for continuous updates and standardization
of protocols to keep pace with technological advancements.