10/25/2010

Diagnosticum Zrt.

Hemoglobin A1c Direct Kit


NEWS BULLETIN

Hemoglobin A1c Direct Kit

Includes

HbA1c Reagent components
HbA1c Hemolysis solvent


Principle

This method utilizes the interaction of antigen and antibody to directly determine the HbA1c in whole blood. Total hemoglobin and HbA1c have the same unspecific absorption rate to latex particles. When mouse antihuman HbA1c monoclonal antibody is added (R2), latex-HbA1c-mouse anti human HbA1c antibody complex is formed. Agglutination is formed when goat anti-mouse IgG polyclonal antibody interacts with the monoclonal antibody. The amount of agglutination is proportional to the amount of HbA1c absorbed on to the surface of latex particles. The amount of agglutination is measured as absorbance. The HbA1c value is obtained from a calibration curve.

Shelf life of the kit: 14 months

Stability of working reagent: stable up to 30 days (at 2-8 °C)

Hemoglobin A1c in whole blood, collected with EDTA, is stable for one week (at 2-8°C)

Linearity: the Hemoglobin A1c assay range is 2.0%-16.0%.

Accuracy
Level Mean (%) Std. Dev. % C.V.
Low 5.48 0.078 1.43
High 10.28 0.176 1.72
Low 5.48 0.152 2.77
High 10.28 0.275 2.68

Control
Both NGSP (%) and IFCC (mmol/mol Hb) values are indicated
Kit includes: 2x0,5 ml normal level plus 2x0,5 ml elevated level

Calibrator:
Both NGSP (%) and IFCC (mmol/mol Hb) values are indicated
Kit includes: 4x0,5 ml, four levels, 1 vial each level.

Correlation
Arkray Adams HPLC and ADVIA 1650 biochemistry analyser
Y=1,0374-0,6802
R2=0,9511

Order information
Cat No. Item Unit
318000 HbA1c Direkt 40 ml 30 ml + 10 ml
318CAL HbA1c Calibrator Set 4 x 0,5 ml
318CON HbA1c Control Set 2 x 0,5 ml

Number of tests: Hitachi, Olympus, BioLis: 120 tests/kit
ADVIA, Konelab: 200 tests /kit