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Konelab in diabetes testing

Konelab in diabetes testing. Glucose HbA1c Microalbuminuria. Topics. Diabetes, history and classification. Konelab system tests for diabetes monitoring. HbA1c, history, facts and measurement. HbA1c on Konelab. Scientific reports. Konelab test menu. Diabetes mellitus, history in a nutshell.

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Konelab in diabetes testing

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  1. Konelab in diabetes testing GlucoseHbA1cMicroalbuminuria

  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: Solid complex Excess of antibody Sample Unsoluble complex Polyhapten

  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, 981925 or 981926 HbA1c without any modifications • HbA1c Pretreatment liquid, 981924, 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 • HbA1c test kit • Code 981925 for 600 tests • Code 981926 for 200 tests • Including system specified calibrators • Sample pretreatment • Kit for automated on-board hemolyzation, HbA1c Pretreatment Liquid, code 981924 • Chemical for manual hemolyzation, code 981659 • System specified controls • HbA1c Control Normal, code 981695 • HbA1c Control Abormal, code 981696

  16. Scientific reports, method evaluationPublished 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 hemolyzationPublished 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. 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 Konelab Menu – over 80 carefully validated methods 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

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