CRP
C-Reactive Protein
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Cat. No.:
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KAI-026
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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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1 - 250 mg/L
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0.1 - 25.0 mg/dL
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Sample:
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Serum
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KIT COMPOSITION
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INTENDED USE
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For the quantitative determination of C-reactive protein (CRP) in serum by
immunoturbidimetric assay. Measurement of CRP aids in the evaluation
of the amount of injury to body tissues.
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.
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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 reagents can be used for one month if stored at 2-8°C.
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PERFORMANCE
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Precision
The precision for the
K-ASSAY ®
CRP assay was determined using packaged reagents, normal human serum spiked with known concentrations of human CRP, and a Hitachi 704 analyzer.
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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 = 0.646
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Mean = 3.147
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Mean = 10.354
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S.D. = 0.0278
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S.D. = 0.0399
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S.D. = 0.1052
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C.V. = 4.30%
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C.V. = 1.27%
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C.V. = 1.02%
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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 = 6
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N = 6
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N = 6
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Mean = 1.97
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Mean = 5.33
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Mean = 11.08
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S.D. = 0.10
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S.D. = 0.10
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S.D. = 0.2
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C.V. = 5.25%
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C.V. = 1.94%
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C.V. = 0.68%
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Accuracy / Correlation
A comparison of the
K-ASSAY ®
CRP assay and another company's CRP Test Kit was performed using a Hitachi 704. The test results provided the following data:
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y = 0.9737x + 0.0003
r = 0.99838
x = another company's CRP assay
y = K-ASSAY ® CRP assay
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Assay Range
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1 - 250 mg/L
or
0.1 - 25.0 mg/dL
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INTERFERENCE
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Bilirubin :
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No interference up to 20 mg/dL
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Hemoglobin :
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No interference up to 500 mg/dL
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Intralipid :
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No interference up to 500 mg/dL
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