CRP (3)
C-Reactive Protein (3)
Wide Range CRP
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Cat. No.:
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KAI-082
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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
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Linearity:
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With CRP (3) Calibrator Set E (Cat. No. KAI-084C) :
0.05 - 160 mg/L
or
0.005 - 16.0 mg/dL
With CRP (3) Calibrator Set F (Cat. No. KAI-086C) :
0.2 - 480 mg/L
or
0.02 - 48.0 mg/dL
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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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K-ASSAY ®
CRP (3) is intended to be used as a high-sensitive assay for the quantitative
determination of CRP in serum and plasma by immunoturbidimetric assay.
Measurement of C-Reactive Protein aids in the detection and evaluation of tissue injury,
inflammatory disorders, and related diseases.
FOR IN VITRO DIAGNOSTIC USE.
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REAGENT PREPARATION
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The reagents are ready to use and do not require reconstitution. Mix
gently before using.
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STORAGE AND HANDLING
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All reagents should be stored at 2-8°C and protected from light. Unopened reagents
can be used for 18 months from the date of manufacture as indicated on the expiration
date on the package and bottle labels. Once the reagent vial has been opened, store
tightly capped at 2-8°C and use within 1 month.
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PERFORMANCE
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Precision
The following data was obtained using a Hitachi 917 analyzer and standard protocol.
Samples tested were commercial human CRP control serum.
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Precision - Within Run - Using CRP (3) Calibrator Set D
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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 = 0.48 mg/L
or
Mean = 0.048 mg/dL
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Mean = 2.42 mg/L
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Mean = 0.242 mg/dL
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Mean = 9.80 mg/L
or
Mean = 0.980 mg/dL
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S.D. = 0.02
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S.D. = 0.04
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S.D. = 0.09
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C.V. = 4.3%
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C.V. = 1.6%
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C.V. = 0.87%
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Precision - Between Runs - Using CRP (3) Calibrator Set D
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Sample I
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Sample II
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Sample III
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N = 21
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N = 21
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N = 21
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Mean = 0.5 mg/L
or
Mean = 0.05 mg/dL
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Mean = 2.2 mg/L
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Mean = 0.22 mg/dL
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Mean = 9.8 mg/L
or
Mean = 0.98 mg/dL
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S.D. = 0.03
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S.D. = 0.07
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S.D. = 0.12
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C.V. = 6.97%
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C.V. = 3.35%
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C.V. = 1.23%
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Accuracy / Correlation
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y = 1.012x + 0.0051
r = 0.999
x = Company A's latex hsCRP nephelometric assay
y = K-ASSAY ® CRP (3)
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Assay Range
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With CRP (3) Calibrator Set D (Cat. No. KAI-083C) :
0.1 - 320 mg/L
or
0.01 - 32.00 mg/dL
With CRP (3) Calibrator Set E (Cat. No. KAI-084C) :
0.05 - 160 mg/L
or
0.005 - 16.0 mg/dL
With CRP (3) Calibrator Set F (Cat. No. KAI-086C) :
0.2 - 480 mg/L
or
0.02 - 48.00 mg/dL
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INTERFERENCE
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Bilirubin F and C :
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No interference up to 30 mg/dL
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Hemoglobin :
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No interference up to 500 mg/dL
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Lipid :
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No interference up to 5% Intrafat
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Rheumatoid Factor :
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No interference up to 560 IU/mL
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