Standardization of clinical mass spectrometry: Impacting the healthcare industry

Contributing lab leader: Dušanka Kasapić

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.

Article highlights:

  • Clinical mass spectrometry is becoming an important component of routine clinical diagnostics.
  • As the tool becomes more widely available, there is a need to standardize processes to ensure consistent and comparable patient results.
  • Standardization offers several advantages including accuracy and reliability of analyte measurements and reduced inter-laboratory and inter-test variability.
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Infographic transcript

The benefits of standardizing using clinical mass spectrometry

Due to its analytical benefits, mass spectrometry is becoming more popular in routine medical laboratories.

With its high sensitivity and specificity, mass spec offers simultaneous measurement of bioactive compounds, precursors, and metabolites in a single sample for screening and clinical diagnostics across a broad range of areas such as therapeutic drug monitoring and toxicology. Standardizing clinical mass spec ensures true, reliable, and consistent patient results with traceable reference measurement procedures.

This standardization helps broaden the adoption of clinical mass spec and at the same time, impacts patient care.

Benefits of standardizing clinical mass spec:

  • Enhance the accuracy and reliability of analyte measurements Improve inter-laboratory measurement
  • Reduce inter-laboratory and inter-test variability within routine laboratories 
  • Provide consistency of patient results, independent of time and place


Commercial support for calibration standards

Reference materials available

Results directly comparable


Improving standardization in LC-MS/MS  Better reference material availability and commercial support for calibration standards among labs help ensure directly comparable results.

Benefits of traceability:

An important step in standardizing clinical mass spec is the development and validation of traceable reference measurement procedures.

Traceable to a higher-order reference material

  • Standardization of new and routine assayes
  • Evaluation of clinically relevant samples

Free of systematic error and in accordance with ISO guidelines2

  • Evaluation of clinically relevant patient samples to ensure accuracy
  • Improved inter-lab measurement accuracy and comparability
  • Reduced inter-lab and inter-test variability

1. Benton SC, et al. Clin Chem Lab Med. 2020;58(6):1010-17.

2. International Organization for Standardization. ISO 17511:2020. In vitro diagnostic medical devices‐Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples. Geneva, Switzerland: ISO;2020.

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  1. Stevens & Pukala. (2020). Trends Analyt Chem 132, 116064. Paper available from [Accessed April 2024]

  2. Seger & Salzmann (2020). Clin Biochem 82, 2–11. Paper available from [Accessed April 2024]

  3. Vogeser & Zhang (2018). Clin Mass Spectrom 9, 1–6. Paper available from [Accessed April 2024]

  4. Dirks et al. (2021). Clin Chim Acta 514, 80–83. Paper available from [Accessed April 2024]

  5. Benton et al. (2019). Clin Chem Lab Med 58, 6, 1010–1017. Paper available from [Accessed April 2024]

  6. Sturgeon (2014). Clin Chim Acta 432, 122-126. Paper available from [Accessed April 2024]

  7. Junger et al. (2023). JMSACL 30, 1-9. Paper available from [Accessed May 2024]

  8. Panteghini & Braga (2020). Clin Chem Lab Med 58, 8, 1200–1204. Paper available from [Accessed April 2024]