Standardization of clinical mass spectrometry: Impacting the healthcare industry

Mass spectrometry is paving the way for the next generation of routine clinical diagnostics, now being used across multiple medical areas like endocrinology, therapeutic drug monitoring, and toxicology.¹ Today, many lab leaders are integrating the analytical tool into their workflows, designed for the highly specific and sensitive identification and quantification of small molecules, peptides, and proteins. 

To ensure better comparability and consistency of patient results, standardization is becoming a critical component for more accurate and reliable clinical decision-making based on liquid chromatography with tandem mass spectrometry (LC-MS/MS).² Despite the analytical advantages of clinical mass spectrometry in diagnostics, the challenge of comparing results between different labs still remains. For example, certified reference materials or referent method procedures may be unavailable, methods are developed in-house, and/or assays are independently set up on individual analyzers –  all potentially leading to human error, high inter-lab variability, and lack of consistency.^3-6

Due to these challenges, lab leaders need to find LC-MS/MS solutions that offer commercial support for reference material and calibration standards that are widely available for LDTs or CE-approved/IVD-approved LC-MS/MS reagent kits as well as standardized hardware/system solutions to ensure that results are directly comparable.⁷

Standardization can help lab leaders:^2-6,8

• Enhance the accuracy and reliability of analyte measurements

• Reduce inter-laboratory variability and improve comparability

• Provide consistency of patient results, independent of time and place.

To aid in standardization and the development and validation of new reference measurement procedures (RMPs) for LC-MS/MS, the Joint Committee for Traceability in Laboratory Medicine (JCTLM) plays an important role in promoting global standardization of clinical lab test results, providing information on reference measurement methods, materials, services and ensuring worldwide access.⁷ Lab leaders need clinical mass spec solutions and providers that offer reagent kits that are well-standardized and traceable to RMPs. 

By being mindful of the standardization of clinical mass spectrometry and assays, lab leaders can provide benefits to biomedical research and deliver true, reliable, and consistent results to patients and clinicians.