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Fibrinogen
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Cat. No.:
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KAI-135
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Type:
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Reagent
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Method:
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Immunoturbidimetric
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Format:
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Liquid (Lyophilized Calibrator)
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Linearity:
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100 - 900 mg/dL
or
81 - 729 mg/dL (using NIBSC international standard)
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Sample:
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Plasma
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KIT COMPOSITION
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INTENDED USE
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For the quantitative determination of fibrinogen levels in disseminated intravascular coagulation
(non-localized clotting within the blood vessels) and primary fibrinolysis (the dissolution of
fibrinogen in a blood clot.
FOR IN VITRO DIAGNOSTIC USE.
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REAGENT PREPARATION
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R1 and R2 are ready to use and do not require reconstitution.
The calibrator is lyophilized and requires reconstition and preparation of dilutions
according the the package insert instructions.
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STORAGE AND HANDLING
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All reagents should be stored refrigerated (2-8°C). Return all reagents to
2-8°C promptly after use. Unopened reagents can be used for one year from the
date of manufacture, as indicated by the expiration date on the package and bottle
labels. Opened R1 and R2 can be used for one month if stored at 2-8°C.
Reconstituted fibrinogen calibrator and the diluted calibrator solutions can be
used for 1 week if stored at 2-8°C.
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PERFORMANCE
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Precision
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Precision - Within Run
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Sample I
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Sample II
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Sample III
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N = 20
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N = 20
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N = 20
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Mean = 142.4
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Mean = 444.7
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Mean = 739.6
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Min = 136
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Min = 429
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Min = 721
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Max = 152
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Max = 456
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Max = 763
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C.V. = 2.96%
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C.V. = 1.48%
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C.V. = 1.43%
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Precision - Between Runs
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Sample I
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Sample II
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Sample III
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N = 10
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N = 10
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N = 10
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Mean = 167.4
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Mean = 323.6
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Mean = 554.1
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Min = 165
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Min = 316
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Min = 544
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Max = 170
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Max = 329
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Max = 571
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C.V. = 0.94%
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C.V. = 1.06%
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C.V. = 1.50%
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Accuracy / Correlation
A comparison of the
K-ASSAY ®
Fibrinogen test and an Incstar Fibrinogen Test Kit was performed using a Hitachi 717. The test results provided the following data:
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y = 0.967x + 33.91
r = 0.995
n = 50
x = Incstar Fibrinogen Test Kit
y = K-ASSAY ® Fibrinogen
Additional correlation studies on assays using the Clauss method (clotting method) are available.
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Assay Range
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100 - 900 mg/dL
or
81 - 729 (using NIBSC international standard)
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INTERFERENCE
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Bilirubin C :
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No interference up to 25 mg/dL
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Hemoglobin :
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No interference up to 500 mg/dL
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