Konelab in diabetes testing Glucose HbA1c Microalbuminuria.

Konelab in diabetes testing

GlucoseHbA1cMicroalbuminuria

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Topics

HbA1c on Konelab

Konelab system tests for diabetes monitoring

HbA1c, history, facts and measurement

Scientific reports

Diabetes, history and classification

Konelab test menu

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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

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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.

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Konelab system tests for diabetes monitoring

For short term monitoring

• Glucose

For long term monitoring

• HbA1c

• Microalbuminuria

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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

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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.

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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

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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

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Immunological HbA1c assay in details

Reaction:

Excess of antibody

Solidcomplex

Polyhapten Unsolublecomplex

Sample

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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

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NGSP certified HbA1c test on Konelab

Method correlation to the reference laboratory

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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

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Automated HbA1c – eliminate all unnecessary steps

Materials needed for manual pretreated HbA1c test

When automated

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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

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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

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Imprecision study for Konelab HbA1c assay

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Method comparison study for HbA1c assay

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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

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Method comparison between manual and automated hemolyzation

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Albumin ACPTot & Dir Bil ALPBicarbonate ALT/GPTCalcium AST/GOTCholesterol AmylaseHDL&LDL Chol CHECreatinine DibucaineGlucose CKIron CK-MBMagnesium Gamma-GTPhosphorus -HBDHTotal Protein LDHTriglycerides LipaseU/CSF ProteinUrea ELECTROLYTESUric Acid Na, K, Cl

Ca, pH

Konelab Menu – over 80 carefully validated methods

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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

CarbamazepinePhenobarbitalPhenytoinTheophyllineValproic AcidLithium

SP

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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