March 2017

LGC announces the addition of a new immunosuppressant certified reference material to our portfolio: pure tacrolimus (ERM®-AC022a)

LGC, in its role as the UK’s National Measurement Laboratory and Designated Institute for chemical and bio-measurement, has expanded its portfolio of immunosuppressant certified reference materials (CRMs) to include a new pure tacrolimus material (ERM®-AC022a).
Certified reference materials for clinical analytes are required to help remove 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®-AC022a: pure tacrolimus was certified for purity using a combination of analytical techniques accredited to ISO 17025, and the results confirmed by quantitative NMR.
This material has been produced under LGC’s accreditation to ISO Guide 34 as a Reference Material Producer and accepted as a European Reference Material (ERM®) following peer-review, with homogeneity and stability studies carried out.
The intended use of this material is for the calibration of instruments, quality control, and validation of methods to determine the immunosuppressant drug tacrolimus. It can also be used for the calibration of instruments. This material will help support laboratories, secondary standards producers and assay developers to ensure compliance with ISO15189.
Our current portfolio of immunosuppressant reference materials also includes pure sirolimus (ERM®-AC021a) and tacrolimus in whole human blood (ERM®-DA110a). All our materials are available from LGC Standards.
For further information please contact uksales@lgcstandards.com.