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|Method & Line||Sample & Target||Product||Package Info|
|Clinical Chemistry||Whole blood||HbA1c||Tests per Package: 100|
|Pchem Reagents||The Pchem HbA1c Reagent Kit has been designed for use in the quantitative determination in vitro of the Hemoglobulin A1c (HbA1c) concentration in human whole blood collected with EDTA||Code: ADA-R0200000900||Package: R1 1 x 15 mL; R2 1 x 5 mL; R3 1 x 2.5 mL|
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The Pchem HbA1c Reagent Kit has been designed for use in the quantitative determination in vitro of the Hemoglobulin A1c (HbA1c) concentration in human whole blood collected with EDTA.
This kit is intended for In vitro diagnostic use only, must not be sold to the general public and the test has to be carried out by a health-care professional person.
The kit contains reagents sufficient for 100 tests.
Hemoglobin A1c (HbA1c) is a glycated hemoglobin which is formed by the non-encymatic reaction of glucose with native hemoglobin. This process runs continuously throughout the circulatory life of the red cell (average life time 100 - 120 days). The rate of glycation is directly proportional to the concentration of glucose in the blood. The blood level of HbA1c represents the average blood glucose level over the preceding 6 to 8 weeks (due to the kinetics of erythrocyte turnover this period is more affected by the blood glucose level than the preceding weeks). Therefore, HbA1c is suitable for retrospective long-term monitoring of blood glucose concentration in individuals with diabetes mellitus. Clinical studies have shown that lowering of HbA1c level can help to prevent or delay the incidence of late diabetic complications. As the amount of HbA1c also depends on the total quantity of hemoglobin the reported HbA1c value is indicated as a percentage of the total hemoglobin concentration.
Falsely low values (low HbA1c despite high blood glucose) may occur in people with conditions with shortened red blood cell survival (hemolytic diseases) or significant recent blood loss (higher fraction of young erythrocytes). Falsely high values (high HbA1c despite normal blood glucose) have been reported in iron deficiency anemia (high proportion of old erythrocytes). These circumstances have to be considered in clinical interpretation of HbA1c values.
Particle enhanced immunoturbidimetric test HbA1c is determined directly without measurement of total hemoglobin.
Total Hb and HbA1c in hemolyzed blood bind with the same affinity to particles in R1. The amount of binding is proportional to the relative concentration of both substances in the blood. Mouse anti-human HbA1c monoclonal antibody (R2) binds to particle bound HbA1c. Goat anti-mouse IgG polyclonal antibody (R3) interacts with the monoclonal mouse anti-human HbA1c antibody and agglutination takes place. The measured absorbance is proportional to the HbA1c bound to particles, which in turn is proportional to the percentage of HbA1c in the sample.
The assay is standardized according to the approved IFCC reference method . Calibration according to DCCT/NGSP is also possible. Corresponding calibrator values are listed in the package insert of the calibrator set dedicated (code AD-R0300000000).
NGSP and IFCC values show a linear relationship and can therefore be calculated from each other using the following equation:
HbA1c (IFCCb) = (HbA1c (NGSPa) – 2.15) / 0.0915
HbA1c (NGSPa) = 0.0915 x HbA1c (IFCCb) + 2.15
a: NGSP values in %
b: IFCC values in mmol/mol
Formula for conversion of IFCC values from % into mmol/mol:
[mmol/mol IFCC] = 10 x [% IFCC]
IFCC: International Federation of Clinical Chemistry
DCCT: Diabetes Control and Complications Trial
NGSP: National Glycohemoglobin Standardization Program
HbA1c and Average Glucose concentrations
Due to a linear correlation between hemoglobin A1c and average glucose concentrations HbA1c values can be converted in estimated average glucose values by means of the following equations:
Standardization according to IFCC:
Average glucose conc. [mg/dL] = 2.63 x HbA1ca + 15.01
Average glucose conc. [mmol/L] = 0.146 x HbA1ca + 0.829
a: HbA1c values in mmol/mol IFCC
Standardization according to NGSP:
Average glucose concentration [mg/dL] = 28.7 x HbA1cb- 46.7
Average glucose concentration [mmol/L] = 1.59 x HbA1c b - 2.59
b: HbA1c values in % NGSP
No significant differences in the regression equation were observed for variations in individuals tested, including sex, presence or absence of diabetes, type of diabetes, age, race, and ethnicity. Although this equation can be used for the majority of individuals each laboratory has to reassure itself if the regression equations mentioned are applicable for the patient group to be examined.
Pchem HbA1c Reagent Kit
Reagent 1 (R1) - 1 x 15 mL/vial
Reagent 2 (R2) - 1 x 5 mL/vial
Reagent 3 (R3) - 1 x 2.5 mL/vial