1. Konelab in diabetes testing
Glucose HbA1c Microalbuminuria

2. Topics Diabetes, history and classification
Konelab system tests for diabetes monitoring
HbA1c, history, facts and measurement
HbA1c on Konelab
Scientific reports
Konelab test menu

3. Diabetes mellitus, history in a nutshell
1552 BC, Egypt – polyuria, earliest known record of diabetes by physician Hesy-Ra
1st Century AD, Arateus defined diabetes as ’the softening of limbs and flesh into urine.’
11th Century, diabetes was diagnosed by ’water tasters’ and people’s urine suffering from diabetes was tested to be sweet tasting.
16th Century, diabetes was identified as a severe common disorders.
16th Century, UK – ’saccarine materials’ detected in urine
19th Century, Germany - pancreas contains two systems of cells, one secreting pancreatic juice, the other, later named ’islets of Langerhans’ was unknown
1889, France – tests when pancreas is removed
1921, discovery and extraction of insulin (Dr. Banting et al, Toronto)
1922, first patient treated by injection of insulin
1944, the standard insulin syringe introduced
1959, type 1 and 2 diabetes identified
1982, the first biosynthetic human insulin developed

4. Diabetes, classification
Type 1 diabetes mellitus
Characterized by loss of the insulin-producing beta cells of the islets of Langerhans in the pancreas, leading to a deficiency of insulin.
It is about 10% of diabetes mellitus cases in North America and Europe (though this varies by geographical location), and is a higher percentage in some other areas.
Type 2 diabetes mellitus
Type 2 diabetes mellitus is characterized differently due to insulin resistance or reduced insulin sensitivity, combined with reduced insulin secretion.
Additionally classified
Gestational Diabetes
Other types, genetic mutations, non-responding insulin receptors etc.

5. Konelab system tests for diabetes monitoring
For short term monitoring
Glucose
For long term monitoring
HbA1c
Microalbuminuria

6. History of HbA1c
1958 Hemoglobin A1c, separated from other forms of Hb by Huisman et al using chromatograph
1968 characterized as a glycoprotein by Bookchin et al.
1969 relationship to diabetes by Rahbar et al
1976 the use for monitoring the diabetes status by Koenig et al

7. Facts about HbA1c
Glycosylated or glycated hemoglobin, a form of hemoglobin located in the erythrocytes.
The average life span of the erythrocytes is 100 – 120 days => HbA1c reflects the average blood glucose level during 2 – 3 months.
HbA1c is suitable for monitoring long-term blood glucose with diabetes.

8. Methods for HbA1c measurement
Based on charge differences
Ion-Exchange Chromatography
HPLC
Electrophoresis
Isoelectric Focusing
Structural differences
Affinity Chromatography
Immunoassay <= Konelab
Chemical analysis
Colorimetry
Spectrophotometry

9. Immunological HbA1c assay in details
Typically the epitope of the antibody is located in first aminoacids of the HbA1c
Improved specificity
Less non-specific reactions between different Hb variants

10. Immunological HbA1c assay in details
Reaction:
Excess of
antibody
Solid
complex
Sample
Polyhapten
Unsoluble
complex

11. HbA1c test on Konelab Immunological method
Total Hb and HbA1c measured from hemolyzed sample (EDTA, capillary or heparinized blood)
Automatic calculation for HbA1c%, according to the IFCC or DCCT/NGSP recommendation.
DCCT/NGSP results on Konelab correlate well with the results from HPLC

12. NGSP certified HbA1c test on Konelab
Method correlation to the reference laboratory

13. Fully automated HbA1c HbA1c with automated pretreatment
SW version needed: 7.1
Dedicated sample segment
Reagents:
Test kit, or HbA1c without any modifications
HbA1c Pretreatment liquid, , ready for use
In barcoded system vessel
Kit size 12 x 20 ml, estimated for 1000 samples
Highlights:
Automated, savings in manpower and consumables
Minimized operator to operator variation

14. Automated HbA1c – eliminate all unnecessary steps
Materials needed for manual pretreated HbA1c test
When automated

15. HbA1c test kits for Konelab, summary
Code for 600 tests
Code for 200 tests
Including system specified calibrators
Sample pretreatment
Kit for automated on-board hemolyzation, HbA1c Pretreatment Liquid, code
Chemical for manual hemolyzation, code
System specified controls
HbA1c Control Normal, code
HbA1c Control Abormal, code

16. Scientific reports, method evaluation Published in IFCC Euromedlab, XIV European Congress of Clinical Chemistry and Laboratory Medicine, Prague, May 2001.
EVALUATION OF A GLYCOHEMOGLOBIN (HbA1c) ASSAY ON KONELAB 60i ANALYZER
Helenius Tuula (1), Kurki, Mirja (1), Lampinen, Hannu (1), Kuronen, Birgitta (2)
(1) Thermo Clinical Labsystems, Espoo, Finland
(2) Finland Clinical Laboratory, Oulaskangas Hospital, Oulainen, Finland
Imprecision study
Method comparison between Konelab and HPLC
Linearity study
Sample stability and interference study

17. Imprecision study for Konelab HbA1c assay

18. Method comparison study for HbA1c assay

19. Scientific reports, the evaluation of an automated hemolyzation Published in XXXI Nordic Congress in Clinical Chemistry, Helsinki June 14-18, 2008
EVALUATION OF A FULLY AUTOMATED WHOLE BLOOD GLYCOHEMOGLOBIN (HbA1C%) ASSAY ON KONELAB 60 CLINICAL CHEMISTRY ANALYZER
Marjoniemi, E. (1); Kurki, M. (2); Kytö, R. (2); Lampinen, H. (2); Vainio, U-M. (1) and Finell, J. (2)
(1) Clinical Laboratory, Oulaskangas Hospital, Oulainen, Finland
(2) Thermo Fisher Scientific, Vantaa, Finland
Method comparison between automated and manual hemolyzation
Precision study of automated on-board hemolyzation

20. Method comparison between manual and automated hemolyzation

21. Konelab Menu – over 80 carefully validated methods
Albumin ACP
Tot & Dir Bil ALP
Bicarbonate ALT/GPT
Calcium AST/GOT
Cholesterol Amylase
HDL&LDL Chol CHE
Creatinine Dibucaine
Glucose CK
Iron CK-MB
Magnesium Gamma-GT
Phosphorus -HBDH
Total Protein LDH
Triglycerides Lipase
U/CSF Protein
Urea ELECTROLYTES
Uric Acid Na, K, Cl
Ca, pH
ENZYMES
SUBSTRATES

22. Konelab Menu – over 80 carefully validated methods
Albumin
Antistreptolysin O
 -1-Antitrypsin
Apo A1 & B
Complement C3
Complement C4
C-reactive protein
High Sensitive CRP
HbA1c
Haptoglobin
IgA, G & M
Microalbuminuria
Myoglobin
Orosomucoid
Prealbumin
Rheumatoid factors
Transferrin
sTfR
Cystatin C
Lipoprotein(a)
Ceruloplasmin
Amphetamine
Barbiturates
Benzodiazepines
Cannabinoids
Cocaine Metabolite
Opiates
Cotinine
Ethyl Alcohol
Methadone
Propoxyphene
Carbamazepine
Phenobarbital
Phenytoin
Theophylline
Valproic Acid
Lithium
TDM
DoA (DAT)
SPECIFIC PROTEINS

23. Konelab System Reagents
Proven, continuously expanding test menu
Delivered in optimal package sizes to suit the needs of small and large laboratories
Ready-to-use liquid reagents for ease of use