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VETSPEC™REAGENTS - Fructosamine

Intended Use

For IN VITRO diagnostic use in the quantitative determination of Fructosamine in serum using manual or automated applications.

Method Principle

Catachem’s kinetic test for Fructosamine (glycated protein) is based on the ability of ketoamines to reduce Nitroblue Tetrazolium in alkaline conditions to form a purple colored Formazan complex. By monitoring the intensity of the color produced at 530 nm, the concentration of Fructosamine in the serum or plasma sample is determined.

Reagent Storage And Stability

Catachem Fructosamine reagents (R1 and R2) are stored at 2-8°C. When stored as directed the reagents are stable until expiration date stated on the label.

Working Reagent Preparation

The Fructosamine Working Reagent is prepared by simply mixing the contents of Reagent 1 with the contents of Reagent 2. Once mixed, the Working Reagent is stable for 60 days at 2-8°C.

Method Performance Characteristics

Sensitivity: Using a pathlength of 1 cm, a D-absorbance of 0.003-0.0038 per μmol/L should be obtained.
Linearity: This procedure is linear over the range of 10-1000 μmol/L
Precision: Precision data was obtained using three levels of commercially available controls and following the NCCLS EP5-T2 procedure.

Precision

    Within-Run

     Day-Day

Total

Mean

SD

CV

SD

CV

SD

CV

μmol/L

μmol/L

%

μmol/L

%

μmol/L

%

215

9.8

4.45

15.9

8.04

15.98

7.78

513

14.29

2.78

22.37

4.68

25.91

5.23

830

19.34

2.78

27.17

3.44

30.81

3.81

 

Accuracy

Using an automated analyzer, correlation studies were carried out between this Fructosamine procedure (Y) and a commercially available Fructosamine test procedure as reference (X). Serum samples were assayed and the results compared by the least squares regression. The following statistics were observed:

Correlation Data

Parameters

DataObserved

N

40

Range    (μmol/L)

60-980

Mean Y (μmol/L)

416.9

Mean X (μmol/L)

385.7

Regression

Y = 1.060x - 8.55

Correlation

r = 0.995

Sy,x

26.82