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 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

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.

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

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

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.

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

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

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

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

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

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

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

HbA1c test kits for Konelab, summary 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

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

Imprecision study for Konelab HbA1c assay

Method comparison study for HbA1c assay

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

Method comparison between manual and automated hemolyzation

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

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

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