Metrological Traceability of the Waters™ MassTrak™ Immunosuppressant Calibrator and Quality Control Sets

Importance of the Topic

The accurate measurement of immunosuppressant drugs in whole blood is critical for patient safety and effective therapy management. Metrological traceability ensures consistency across laboratories, supports compliance with ISO 15189 requirements, and promotes harmonization of results when employing LC-MS/MS–based laboratory developed tests.

Objectives and Overview of the Study

This application note presents the Waters MassTrak Immunosuppressant Calibrator and Quality Control Sets (IVD) designed to provide metrologically traceable, ready-to-use lyophilized materials. The study evaluates their accuracy, lot-to-lot reproducibility, and potential to streamline clinical workflow.

Methodology and Used Instrumentation

• Calibrators and QCs: Lyophilized human whole blood spiked with cyclosporine, everolimus, sirolimus, and tacrolimus.
• Traceability assessment: Comparison with secondary reference materials and independent international proficiency testing (IPT) schemes.
• Measurement platform: Routine LC-MS/MS methods to evaluate accuracy and reproducibility.

Main Results and Discussion

• Laboratory Efficiency Improvements: Ready-to-use reagents eliminate manual preparation steps, reducing pre-analytical workload and potential preparation errors.
• Stability and Shelf Life: Lyophilized sets remain stable for up to three years, with in-use stability of at least 31 days after reconstitution.
• Accuracy: Comparison to ERM reference materials and IPT samples confirmed that calibrator concentrations are within acceptable deviation limits across the calibration range.
• Lot-to-Lot Reproducibility: Evaluation of three manufacturing lots demonstrated minimal variation in mean percent deviation from IPT target values, underscoring manufacturing consistency.

Benefits and Practical Applications

• Enhanced confidence in immunosuppressant quantification and uncertainty estimation.
• Streamlined workflows free technical staff for higher-value tasks.
• Supports harmonization of LC-MS/MS assays across clinical laboratories.

Future Trends and Opportunities

• Extension of metrological traceability approaches to additional analyte classes in clinical diagnostics.
• Development of SI-traceable reference materials and measurement procedures to further strengthen standardization.
• Integration of automated sample preparation systems to enhance throughput in high-volume laboratories.
• Use of digital tools and data analytics for real-time monitoring of calibration performance and instrument status.

Conclusion

The Waters MassTrak Immunosuppressant Calibrator and Quality Control Sets deliver metrologically traceable, stable, and reproducible materials that align with ISO 15189 standards. Their adoption reduces manual preparation, enhances measurement accuracy, and supports harmonized LC-MS/MS testing workflows in clinical laboratories.

Reference

No additional literature references were provided in the source document.