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Fructosamine + Calibrator
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Cat. No.:
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KAI-043 or KAI-050
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Type.:
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Reagent
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Method:
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Colorimetric
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Format:
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Mix To Reconstitute
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Linearity:
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1.0 - 10.0 mmol/L
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Sample:
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Serum
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KIT COMPOSITION
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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)
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Click Image To Enlarge
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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)
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Click Image To Enlarge
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Click here for information about recommended calibrators and controls.
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INTENDED USE
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For the quantitative determination of Fructosamine in human serum.
FOR IN VITRO DIAGNOSTIC USE.
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REAGENT PREPARATION
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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.
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STORAGE AND HANDLING
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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.
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PERFORMANCE
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Precision
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Precision - Within Day
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Sample I
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Sample II
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N = 10
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N = 10
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Mean = 1.97
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Mean = 5.57
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S.D. = 0.04
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S.D. = 0.10
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C.V. = 2.0%
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C.V. = 1.8%
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Precision - Day to Day
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Sample I
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Sample II
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N = 20
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N = 20
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Mean = 1.91
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Mean = 5.72
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S.D. = 0.06
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S.D. = 0.14
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C.V. = 3.1%
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C.V. = 2.4%
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Accuracy / Correlation
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y = 0.88x + 0.28
r = 0.988
n = 45
x = another company's Fructosamine assay
y = K-ASSAY ® Fructosamine Assay
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Assay Range
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INTERFERENCE
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Bilirubin :
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Negligible effect (<5%) up to 20 mg/dL
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Hemoglobin :
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Negligible effect (<5%) up to 200 mg/dL
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Glucose :
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Negligible effect (<5%) up to 600 mg/dL
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