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.
| Published in | American Journal of Laboratory Medicine (Volume 9, Issue 3) |
| DOI | 10.11648/j.ajlm.20240903.12 |
| Page(s) | 29-40 |
| Creative Commons |
This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited. |
| Copyright |
Copyright © The Author(s), 2024. Published by Science Publishing Group |
Validation, Accuracy, Laboratory Tests
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APA Style
Ali, A. E., Hamza, A. M., Saleh, H. E. (2024). Validation Procedures in Medical Laboratory Testing: A Systematic Review of Best Practices. American Journal of Laboratory Medicine, 9(3), 29-40. https://doi.org/10.11648/j.ajlm.20240903.12
ACS Style
Ali, A. E.; Hamza, A. M.; Saleh, H. E. Validation Procedures in Medical Laboratory Testing: A Systematic Review of Best Practices. Am. J. Lab. Med. 2024, 9(3), 29-40. doi: 10.11648/j.ajlm.20240903.12
AMA Style
Ali AE, Hamza AM, Saleh HE. Validation Procedures in Medical Laboratory Testing: A Systematic Review of Best Practices. Am J Lab Med. 2024;9(3):29-40. doi: 10.11648/j.ajlm.20240903.12
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Download@article{10.11648/j.ajlm.20240903.12,
author = {Abdalla Eltoum Ali and Alneil Mohammed Hamza and Haidar Eltayeb Saleh},
title = {Validation Procedures in Medical Laboratory Testing: A Systematic Review of Best Practices
},
journal = {American Journal of Laboratory Medicine},
volume = {9},
number = {3},
pages = {29-40},
doi = {10.11648/j.ajlm.20240903.12},
url = {https://doi.org/10.11648/j.ajlm.20240903.12},
eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ajlm.20240903.12},
abstract = {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.
},
year = {2024}
}
TY - JOUR T1 - Validation Procedures in Medical Laboratory Testing: A Systematic Review of Best Practices AU - Abdalla Eltoum Ali AU - Alneil Mohammed Hamza AU - Haidar Eltayeb Saleh Y1 - 2024/09/23 PY - 2024 N1 - https://doi.org/10.11648/j.ajlm.20240903.12 DO - 10.11648/j.ajlm.20240903.12 T2 - American Journal of Laboratory Medicine JF - American Journal of Laboratory Medicine JO - American Journal of Laboratory Medicine SP - 29 EP - 40 PB - Science Publishing Group SN - 2575-386X UR - https://doi.org/10.11648/j.ajlm.20240903.12 AB - 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. VL - 9 IS - 3 ER -
RaiDX Medical Laboratory, Riyadh, Saudi Arabia; Clinical Biochemistry Department, Faculty of Medical Laboratory Science, Alzaiem Alazhari University, Khartoum, Sudan
Clinical Laboratories Sciences Department, College of Applied Medical Sciences, AlJouf University, Sakakah, Saudi Arabia
Clinical Research Laboratory Services, Sylvester Comprehensive Cancer Center (SCCC), Miami University, Miami, USA
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