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Inter-laboratory variability in vancomycin measurement in an external quality assessment scheme 2016-2025
Anders Larsson1, Jonathan Cedernaes1, Mats B Eriksson2
1Department of Medical Sciences, Clinical Chemistry and Pharmacology, Uppsala University, Uppsala, Sweden.
Clinical Biochemistry
|February 8, 2026
Summary
Vancomycin immunoassay results vary significantly between manufacturers, impacting accurate therapeutic drug monitoring. Harmonizing calibration is crucial for consistent patient care and avoiding vancomycin toxicity.
Area of Science:
- Clinical Chemistry
- Pharmacology
- Analytical Science
Background:
- Vancomycin is vital for severe Gram-positive infections.
- Accurate vancomycin plasma levels are essential due to its narrow therapeutic index.
- Inter-platform variability in immunoassays can hinder reliable therapeutic drug monitoring.
Purpose of the Study:
- To assess intermethod bias and temporal trends in vancomycin immunoassays.
- To evaluate the comparability of vancomycin results across different immunoassay platforms.
- To highlight the need for improved calibration harmonization in therapeutic drug monitoring.
Main Methods:
- Analysis of 78 external quality assurance samples (2016-2025).
- Inclusion of results from 7104 assays across seven major immunoassay manufacturers.
- Comparison of manufacturer results against a mean consensus value.
Main Results:
- Significant systematic biases observed for Abbott, Thermo Fisher, Ortho, and Siemens assays.
- Beckman Coulter and Siemens showed notable temporal drifts.
- Coefficients of variation ranged from 0.9% to 12.1% across methods.
Conclusions:
- Commonly used vancomycin immunoassays exhibit considerable intermethod bias and temporal drift.
- Improved calibration harmonization and traceability are necessary.
- Consistent vancomycin therapeutic drug monitoring requires standardized assay performance.
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