Reference materials (RMs) are the cornerstone of accurate and traceable measurements – they are measurement standards which can be used to validate analytical methods, establish traceability and support quality control.
A month ahead of World Metrology Day, we look at the use of our certified reference materials (CRMs, reference materials with evidence of metrological traceability and a statement of measurement uncertainty) to support measurements in the clinic. CRMs help remove measurement variation between hospitals, ensure more precise prognoses and ultimately improve patient care.
CRMs allow manufacturers to establish the traceability of calibrators supplied with diagnostic equipment and they support 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).
One area where standardisation is necessary is the monitoring of immunosuppressants, the therapeutic drugs used to prevent patients rejecting a donor organ after a transplant. With 4,500 organ transplants carried out in the UK each year, there are tens of thousands of people for whom monitoring the dosages of these drugs is crucial in order to allow the donor organs to remain functional for as long as possible.
Whilst life-saving at the right doses, immunosuppressants have a very narrow therapeutic range. Too little and the body rejects the organ. Too much and unnecessary toxic effects occur, potentially causing diabetes, skin cancer or even resulting in kidney failure, leading to a need for dialysis or even further organ donation.
Improving the accuracy of immunosuppressant monitoring through the use of higher order reference standards could reduce the number of rejections and give patients the best possible chance of an improved quality of life, away from hospital beds and dialysis machines.
Over the past few years LGC, as the UK National Measurement Laboratory and Designated Institute for chemical and bio-measurement, has been producing certified reference materials for two commonly prescribed immunosuppressants (tacrolimus, sirolimus) to underpin the standardisation of existing or in-development assays.
A new material has recently been released to extend the current portfolio and support a greater number of laboratories, secondary standards producers and assay developers ensure compliance with ISO 15189, ultimately helping ensure consistent care across transplant centres globally.
Immunosuppressant certified reference materials (CRMs) available from LGC Standards
- ERM-AC021a pure sirolimus
- ERM-AC022a pure tacrolimus (new)
- ERM-DA110a tacrolimus in whole human blood
These materials are produced under LGC’s accreditation to ISO Guide 34 and accredited to ISO 17025. ERM-AC021a and ERM-DA110a are both listed on the JCTLM database of higher order reference materials.