Metrological traceability of the Waters MassTrak immunosuppressant calibrator and quality control sets

In this application note, Waters discusses the requirement for compliance with local regulatory guidelines and international standards in the development and validation of laboratory developed tests (LDTs) within clinical laboratories. The implementation of ISO 15189:2012 in some geographies necessitates the use of metrologically traceable calibration materials. Metrological traceability and accuracy of results are important aspects of the design, development, and manufacture of the Waters MassTrak™ Immunosuppressant Calibrator and Quality Control Sets (IVD), which help laboratories harmonize their results when using validated LC-MS/MS methods. This application note provides an overview of the Waters MassTrak Immunosuppressant Calibrator and Quality Control Sets and their accuracy, as well as comparisons across lot-to-lot testing.