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D-Dimer
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Cat. No.:
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KAI-090
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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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0.5 - 30 µg/mL DDU (or value of highest calibration point
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Sample:
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Serum, Plasma
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KIT COMPOSITION
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INTENDED USE
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The K-ASSAY ®
D-Dimer Assay is an in vitro diagnostic reagent for the
quantitative determination of cross-linked fibrin degradation products containing D-Dimer in
human plasma or serum by immunoturbidimetric assay.
FOR IN VITRO DIAGNOSTIC USE.
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REAGENT PREPARATION
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The reagents are ready to use. They do not need to be reconstituted.
Mix before using by genty inverting the bottles. After openining, gently
invert Reagent 2 once a week.
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STORAGE AND HANDLING
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All reagents should be stored refrigerated (2-8°C) and protected from light.
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 reagents can
be used for one month 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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Serum
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Sample I
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Sample II
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Sample III
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N = 5
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N = 5
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N = 5
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Mean = 2.29
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Mean = 9.60
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Mean = 22.04
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S.D. = 0.06
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S.D. = 0.14
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S.D. = 0.36
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C.V. = 2.7%
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C.V. = 1.4%
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C.V. = 1.6%
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Plasma
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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 = 3.55
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Mean = 11.34
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Mean = 21.12
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S.D. = 0.09
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S.D. = 0.12
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S.D. = 0.12
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C.V. = 2.5%
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C.V. = 1.1%
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C.V. = 0.6%
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Precision - Between Runs
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Serum
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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 = 2.44
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Mean = 10.19
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Mean = 28.43
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S.D. = 0.06
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S.D. = 0.19
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S.D. = 0.27
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C.V. = 2.5%
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C.V. = 1.9%
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C.V. = 0.95%
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Plasma
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Sample I
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Sample II
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Sample III
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N = 5
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N = 5
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N = 5
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Mean = 3.60
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Mean = 11.56
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Mean = 21.55
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S.D. = 0.08
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S.D. = 0.11
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S.D. = 0.28
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C.V. = 2.27%
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C.V. = 0.96%
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C.V. = 1.30%
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Accuracy / Correlation
A comparison of the
K-ASSAY ®
D-Dimer reagent (KAI-090) and the
K-ASSAY ®
D-Dimer reagent (KAI-078) was performed with the following results:
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y = 0.964x - 0.1742
r = 0.9801
n = 80
x = K-ASSAY ® D-Dimer (KAI-078)
y = K-ASSAY ® D-Dimer (KAI-090)
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Assay Range
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0.5 - 30 µg/mL DDU (or value of highest calibration point)
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INTERFERENCE
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Bilirubin F :
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No interference up to 18 mg/dL
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Bilirubin C :
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No interference up to 21.2 mg/dL
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Hemoglobin :
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No interference up to 500 mg/dL
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RF :
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No interference up to 520 IU/mL
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Citric Acid (sodium) :
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No interference up to 500 mg/dL
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Ascorbic Acid :
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No interference up to 100 mg/dL
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NaF :
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No interference up to 400 mg/dL
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Heparin :
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No interference up to 400 mg/dL
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EDTA-2Na :
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No interference up to 100 mg/dL
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Chyle (Formazine Turbidity) :
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No interference up to 3,000
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Fibrinogen :
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No interference up to 500 mg/dL
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