Importance of method validation in biomarker analysis highlighted in new editorial

In a recent editorial published in Current Pharmaceutical Analysis (Volume 18, Issue 6, 2022), researchers Dr. Behrouz Seyfinejad and Dr. Abolghasem Jouyban highlight the importance of method validation in the quantitative analysis of biomarkers. The editorial emphasizes that reliable analytical data is essential for accurate interpretation in pharmaceutical, clinical, and biomedical studies. Analytical method validation ensures that a test method is accurate, precise, and robust, meeting the standards set by regulatory bodies such as the International Union of Pure and Applied Chemistry (IUPAC), Eurachem, and the International Council for Harmonisation (ICH).

The authors address challenges in bioanalysis, particularly with endogenous analytes or biomarkers, which are complicated by biological and analytical variability. They note that incomplete validation and lack of standardization can lead to inconsistent results, as seen in biomarkers like malondialdehyde (MDA) and homovanillic/vanillylmandelic acids. For instance, MDA, a biomarker of oxidative stress, shows wide variations in reported values due to the use of unreliable methods like thiobarbituric acid derivatization, which lacks full validation. Similarly, variations in reference values for neuroblastoma biomarkers stem from uncharacterized analytical methods.

To address these issues, the editorial advocates for comprehensive validation of bioanalytical methods, covering all stages from sample collection to analysis. Key performance parameters, such as selectivity, sensitivity, accuracy, precision, and stability, should be evaluated per guidelines from the US Food and Drug Administration, European Medicines Agency, and Clinical and Laboratory Standards Institute. The authors stress that understanding the biology of biomarkers is crucial for selecting appropriate validation criteria, ensuring that methods are fit for their intended purpose.

This editorial serves as a call to action for researchers to prioritize method validation to enhance the reliability of biomarker data, ultimately advancing biomedical research and clinical outcomes.