1. Laboratory analysis Georg Alfthan

2. Selection of blood measurements Core measurements: CVD risk factors Additional measurements: CVD, Diabetes, Dietary biomarkers Infectious disease markers Environmental exposure biomarkers

3. Critical pre-analytical issues of blood collection Fasting - 8-14 hours, glucose, triglycerides Position of subject sitting 10 min rest lying  8% increase in blood volume Tourniquet - short duration Season - spring vs. winter: cholesterol Physical exercise heavy training  dehydration

4. Documentation of blood collection ID of phlebotomist Date and time of phlebotomy Time from last meal Number of tubes collected Posture and reason if supine Arm and reason if right

5. The procedure for specimen collection, processing and storage 5

6. Type and order of blood tubes 12345 SEER 1 FLS 0 678 3 ml4 ml8 ml4 ml9 ml kääntö ↑↓ 18 kertaa 9 ml ml LiH e Hb A1 c DN A 1 DN A 2 SEER 2 8 ml EDTA 0 9 ml Turn 18 times

7. Processing of blood tubes Storage tubes Deep-freezing Whole blood analysis

8. Cryotube -20 C Cryo Tube -70 C Labelling of aliquots

9. Storage of specimen Short term storage = - 20°C - Core measurements Long term storage = - 70°C - Additional measurements Responsibility of National HES Laboratory ?

10. Selection of National HES Laboratory All core measurements should be performed in the same lab: National HES Lab (NHESL) Selection criteria: performance in external quality assessment program (regular participation) Additional value: The lab is accredited by a national organization

11. Recommendation for analytical methods All analytical methods should be documented and validated Documentation should be available at National HES Laboratory (HESL) and EHES Reference Laboratory (RL)

12. Standardization of analytical data Pilot calibration NHESL EHESRL Reference samples Analytical data Satisfactory performance ! 3 2 1

13. Performance of laboratories Long term verification of bias Bias of NHESL Bias of EHESRL CDC National EQA program

14. Recommended goals for bias of methods Bias (%) Precision (CV%) Core analytes Goal Acceptable Serum tot chol 3 5 2 Serum HDL chol 810 3 Plasma glucose 6 ? 3

15. Corrective measures recommended for National HES Labs if bias exceeds criteria Check calibrators Change reagents (kits) Malfunctioning instruments Wrong type of sample Reagent not compatible with instrument Change method or technique !

16. Long term quality control Documentation of all changes done to methods and procedures Regular reporting to the central EHES RL