New Immunosuppressant Certified Reference Material Announced

LGC has expanded its portfolio of immunosuppressant certified reference materials (CRMs) to include a new sirolimus in whole human blood material (ERM®-DA111a).

Certified reference materials for clinical analytes are required to help reduce measurement variation between hospitals and ultimately improve patient welfare. They allow manufacturers to establish the traceability of values assigned to calibrators supplied with diagnostic equipment, and for medical and clinical laboratories to validate their methods in line with the traceability and uncertainty requirements as defined in the International Organisation for Standardization (ISO) standard 15189 (Medical laboratories – Requirements for quality and competence).

ERM®-DA111a: human blood - sirolimus was certified for its sirolimus mass fraction using an isotope dilution mass spectrometry method accredited to ISO 17025.

This material has been produced under LGC’s accreditation to ISO Guide 34 as a Reference Material Producer and accepted as European Reference Materials (ERM®) following peer-reviews. Homogeneity and stability studies have been carried out and an inter-laboratory study of commutability was conducted following the principles of CLSI document EP30-A.

The intended use of this material is for the calibration of instruments and the validation, quality control and performance monitoring of methods to determine sirolimus in human blood. This material will help support laboratories, secondary standards producers and assay developers ensure compliance with ISO15189.

LGC’s current portfolio of immunosuppressant reference materials also includes pure sirolimus (ERM®-AC021a), pure tacrolimus (ERM®-AC022a) and tacrolimus in whole human blood (ERM®-DA110a).