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Total IgE
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Cat. No.:
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KAI-092
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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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10 - 2,000 IU/mL (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 ®
Total IgE is an in vitro diagnostic reagent for the
quantitative determination of circulating total IgE in human serum or plasma by
immunoturbidimetric assay for use as an aid in the clinical diagnosis of IgE
mediated allergic disorders in conjunction with other clinical findings.
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 gently inverting the bottles. After opening,
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
The precision for the
K-ASSAY ®
Total IgE assay was determined using packaged reagents, pooled human serum, and a Hitachi 917 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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Sample IV
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Sample V
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N = 10
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N = 10
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N = 10
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N = 10
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N = 10
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Mean = 105.3
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Mean = 174.1
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Mean = 350.5
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Mean = 1,117.8
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Mean = 1,908.6
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S.D. = 1.06
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S.D. = 2.85
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S.D. = 7.68
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S.D. = 13.26
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S.D. = 30.25
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C.V. = 1.01%
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C.V. = 1.63%
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C.V. = 2.2%
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C.V. = 1.2%
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C.V. = 1.6%
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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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Sample IV
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Sample V
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N = 10
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N = 10
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N = 10
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N = 10
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N = 10
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Mean = 105.4
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Mean = 177.6
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Mean = 663.7
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Mean = 2,147.5
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Mean = 3,304.7
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S.D. = 2.72
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S.D. = 3.24
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S.D. = 11.22
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S.D. = 33.56
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S.D. = 16.67
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C.V. = 2.58%
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C.V. = 1.82%
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C.V. = 1.69%
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C.V. = 1.56%
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C.V. = 0.50%
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Accuracy / Correlation
A comparison of the
K-ASSAY ®
Total IgE assay and Company X's Total IgE reagent was performed with the following results:
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y = 0.9851x + 10.618
r = 0.9928
n = 80
x = Company X's Total IgE
y = K-ASSAY ® Total IgE
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Assay Range
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10 - 2,000 IU/mL (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 18.5 mg/dL
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Bilirubin C :
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No interference up to 21.6 mg/dL
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Hemoglobin :
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No interference up to 467 mg/dL
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RF :
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No interference up to 500 IU/mL
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Sodium Citrate :
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No interference up to 15 mg/mL
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Sodium Heparin :
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No interference up to 150 IU/mL
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EDTA-2Na :
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No interference up to 1.5 mg/mL
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Chyle (Formazine Turbidity) :
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No interference up to 2,120
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