IgM
Immunoglobulin M
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Cat. No.:
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KAI-015
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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 - 350 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 IgM in serum by imunoturbidimetric assay.
Measurement of IgM aids in the diagnosis of abnormal protein metabolism and the body's
lack of ability to resist infectious agents.
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
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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 = 69
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Mean = 138
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Mean = 207
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S.D. = 0.64
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S.D. = 1.11
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S.D. = 1.35
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C.V. = 0.9%
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C.V. = 0.8%
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C.V. = 0.7%
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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 = 7
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N = 7
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N = 7
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Mean = 94
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Mean = 183
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Mean = 345
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S.D. = 1.4
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S.D. = 0.9
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S.D. = 3.5
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C.V. = 1.5%
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C.V. = 0.5%
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C.V. = 1.0%
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Accuracy / Correlation
A comparison of the
K-ASSAY ®
IgM kit and an INCSTAR IgM Test Kit was performed on a Hitachi 704 automated analyzer and a COBAS Mira. The test results provided the following data:
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y = 1.0927x - 0.71
r = 0.98835
n = 45
x = INCSTAR IgM Test Kit
y = K-ASSAY ® IgM assay
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x
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min
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=
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23
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y
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min
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=
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21
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max
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=
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392
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max
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=
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438
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mean
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=
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138
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mean
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=
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150
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Assay Range
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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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