The objective of the work is the establishment of 3 batches of lyophilized human serum based reference materials for creatinine with the following clinically relevant concentration ranges:
- 50-95mmol/L (reference range)
- 100mmol/L (decision limit)
- 400mmol/L (elevated range).
In addition to the serum reference materials, 3 different batches of vials will be supplied containing compounds which can appear under pathological or therapeutical conditions in human serum and are known to interfere with routine creatinine determinations. The interference-spiked reference material allows to check any creatinine measurement procedure for its robustness.
Despite of the fact that creatinine serum determinations are one of the most frequently performed routine analyses different test kits or analyzers still produce considerably discrepant results.
The in-vitro diagnostic manufacturers are especially encouraged to use this reference material, thus the accuracy transfer from the highest analytical level down to routine methods will be ensured.