laboratory analysis georg alfthan. selection of blood measurements core measurements: cvd risk...
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Laboratory analysis
Georg Alfthan
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Selection of blood measurements
• Core measurements: • CVD risk factors
• Additional measurements: • CVD, Diabetes, Dietary biomarkers
• Infectious disease markers• Environmental exposure biomarkers
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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
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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
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The procedure for specimen
collection, processing and storage
5
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Type and order of blood tubes
1 2 3 4 5
SEER 1
FLS0
6 7 8
3 ml 4 ml 8 ml 4 ml9 ml
kääntö ↑↓ 18 kertaa
9 ml ml
LiHe
HbA1c
DNA1
DNA 2
SEER 2
8 ml
EDTA0
9 ml
Turn 18 times
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Processing of blood tubes
Storage tubes
Storage tubes
Deep-freezing
Whole blood
analysis
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Cryotube-20 C
Cryo Tube-70 C
Labelling of aliquots
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Storage of specimen
• Short term storage = - 20°C- Core measurements
• Long term storage = - 70°C- Additional measurements
Responsibility of National HES Laboratory ?
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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
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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)
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Standardization of analytical data
• Pilot calibration
• • NHESL EHESRL
Reference samples
Analytical dataSatisfactory performance !
3
2
1
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Performance of laboratories
Long term verification of bias
Bias of NHESL
Bias of EHESRL
CDC
National EQA program
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Recommended goals for bias of methods
Bias (%)
Precision (CV%)• Core analytes Goal Acceptable
• Serum tot chol 3 5 2• Serum HDL chol 8 10 3• Plasma glucose 6 ? 3
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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 !
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Long term quality control
• Documentation of all changes done to methods and procedures
• Regular reporting to the central EHES RL