Apo B
Apolipoprotein B
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Cat. No.:
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KAI-004
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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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25 - 250 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 human Apolipoprotein B (Apo B) in 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 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 ®
Apo B assay was determined using packaged reagents, pooled human serum, and a Hitachi 717 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 = 36.0
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Mean = 70.2
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Mean = 120.2
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S.D. = 0.7
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S.D. = 1.5
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S.D. = 1.7
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C.V. = 2.06%
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C.V. = 2.12%
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C.V. = 1.44%
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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 = 58.6
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Mean = 83.3
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Mean = 124.5
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S.D. = 1.3
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S.D. = 1.9
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S.D. = 1.4
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C.V. = 2.25%
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C.V. = 2.33%
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C.V. = 1.09%
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Accuracy / Correlation
A comparison of the
K-ASSAY ®
Apo B assay and a Sigma Apo B Test Kit was performed using a Hitachi 704. The test results provided the following data:
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y = 1.442x + 0.00
r = 0.885
n = 50
x = Sigma Apo B Test Kit
y = K-ASSAY ® Apo B assay
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x
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min
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=
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26
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y
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min
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=
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42
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max
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=
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106
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max
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=
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175
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mean
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=
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65
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mean
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=
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107
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Assay Range
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INTERFERENCE
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Bilirubin C :
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No interference up to 20 mg/dL
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Bilirubin F :
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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 2,000 mg/dL
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