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K-Assay
 
Clinical Diagnostics
Liquid Chemistry Reagents
 





Fructosamine + Calibrator
Cat. No.: KAI-043   or   KAI-050
Type.: Reagent
Method: Colorimetric
Format: Mix To Reconstitute
Linearity: 1.0 - 10.0 mmol/L
Sample: Serum


KIT COMPOSITION
Cat. No. KAI-043
Buffer:   1 X 120 mL
Substrate:   5 X 11 mL
Calibrator:   1 X 2 mL

Tests / Kit:   220 (Hitachi 717)
(Can Vary Based On Analyzer Model)
    
KAI-043
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Cat. No. KAI-050
Buffer:   1 X 120 mL
Substrate:   10 X 11 mL
Calibrator:   1 X 2 mL

Tests / Kit:   440 (Hitachi 717)
(Can Vary Based On Analyzer Model)

    
KAI-050
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Click here for information about recommended calibrators and controls.


INTENDED USE
For the quantitative determination of Fructosamine in human serum.
FOR IN VITRO DIAGNOSTIC USE.

REAGENT PREPARATION
Reconstitute the Fructosamine Substrate with the amount of Fructosamine Buffer specified on the vial label.  Swirl gently to dissolve.  The Fructosamine Calibrator is supplied as a liquid stable serum based product.  It is ready to use upon opening.

STORAGE AND HANDLING
Un-reconstituted reagents are stable until the expiration date on the kit label when stored at 2-8°C.  Upon reconstitution, the substrate should be stored at 2-8°C for best results.  Reconstituted substrate is stable for 7 days if stored at room temperature (15-25°C) or 30 days if stored refrigerated (2-8°C).  After opening, calibrator is stable for 30 days stored at 2-8°C.

PERFORMANCE
Precision

Precision - Within Day
Sample I Sample II
N = 10 N = 10
Mean = 1.97 Mean = 5.57
S.D. = 0.04 S.D. = 0.10
C.V. = 2.0% C.V. = 1.8%

Precision - Day to Day
Sample I Sample II
N = 20 N = 20
Mean = 1.91 Mean = 5.72
S.D. = 0.06 S.D. = 0.14
C.V. = 3.1% C.V. = 2.4%

Accuracy / Correlation
y = 0.88x + 0.28
r = 0.988
n = 45
x = another company's Fructosamine assay
y = K-ASSAY ®   Fructosamine Assay

Assay Range
1.0 - 10.0 mmol/L

INTERFERENCE
Bilirubin :     Negligible effect (<5%) up to 20 mg/dL
Hemoglobin :     Negligible effect (<5%) up to 200 mg/dL
Glucose :     Negligible effect (<5%) up to 600 mg/dL