Metrological traceability of the Waters MassTrak Endocrine Steroid Calibrator and Quality Control Sets

LC-MS/MS methods in clinical laboratories are often based on validated laboratory developed tests (LDTs), which comply with local regulatory guidelines and international standards. In some geographies, laboratories are required to use metrologically traceable calibration materials to aid in compliance with ISO 15189:2012 Medical laboratories–Requirements for quality and competence. Therefore, metrological traceability has been incorporated in to the design, development, and manufacture of the Waters MassTrak Endocrine Steroid Calibrator and Quality Control Sets (IVD), aiding laboratories in their compliance to ISO 15189, and providing confidence in the accuracy and harmonization of results when using validated LC-MS methods. In this application note, Waters provides an overview of the Waters MassTrak Endocrine Steroid Calibrator and Quality Control Sets and their accuracy and comparisons across lot-to-lot testing.