The objective of the work is the establishment of 3 batches of lyophilized human serum based reference materials for 17 beta-estradiol with the following clinically relevant concentration ranges:
- 100 pmol/L level
- 600 pmol/L level
-1500 pmol/L level.
The material should provide for a common point of reference especially to in-vitro diagnostic manufacturers and by that the currently observed lack of agreement between results obtained from different kits should be avoided in future.
The availability of both reference method procedure and reference material are needed to transfer accuracy from the highest analytical level (ID ECMS) down to routine testing.
Quality criteria for the selected laboratories participating in the certification had previously been established: intralab. imprecisions: l 3.5% and intralab. coefficient of variation: max. 5%.