1. Integration of Certified Reference Material (CRM)
Henrik Zetterberg
University of Gothenburg
Ingrid Zegers
Joint Research Centre, European Commission

2. Classical traceability chain
Definition of the SI unit
e.g. AAA,
refractive index
“Pure” protein
Reference procedure, immunoassay ring trial
CRM
matrix material
Value transfer 1:
LC-MS, immunoassay
Manufacturer’s working calibrator
Value transfer 2: immunoassay
Manufacturer’s product calibrator
Immunoassay
CRM material QC
Routine sample 2

3.       Traceability Chain Two MS methods formally certified
by JCTLM:
-C12RMP1
-C11RMP9    

4. Specific for Abeta42 Decision to produce 3 levels
Dilutional linearity not a given
Handling issues (sticking to vials, tips, etc.)
In-house and kit calibrators may not be commutable
Decision to produce 3 levels

5. Use of the CRMs for Abeta42
Three CRMs released on 1st December 2017

6. CRM characterisation ERM-DA480/IFCC ERM-DA481/IFCC ERM-DA482/IFCC 0.45
Certified value
[µg/L]
Uncertainty [µg/L]
ERM-DA480/IFCC
ERM-DA481/IFCC
ERM-DA482/IFCC
0.45
0.72
1.22
0.07
0.11
0.18

7. How should the CRMs be implemented?