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Lp(a) / Lipoprotein (a)
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Cat. No.:
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KAI-044
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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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5 - 150 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 lipoprotein(a) [Lp(a)] in human serum by
immunoturbidimetric assay. The test may provide in conjunction with other
lipoprotein tests, the risk assessment of coronary artery disease for specific populations.
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 = 10.5
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Mean = 22.9
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Mean = 44.9
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S.D. = 0.317
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S.D. = 0.490
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S.D. = 0.587
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C.V. = 3.02%
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C.V. = 2.14%
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C.V. = 1.31%
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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 = 9.7
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Mean = 18.6
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Mean = 45.1
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S.D. = 0.35
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S.D. = 0.40
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S.D. = 0.81
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C.V. = 3.65%
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C.V. = 2.15%
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C.V. = 1.80%
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Accuracy / Correlation
A comparison of the
K-ASSAY ®
Lp(a) and another company's Lp(a) ITA was performed with the following results:
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y = 1.0084x + 1.1518
r = 0.9967
n = 85
x = another company's Lp(a) assay
y = K-ASSAY ® Lp(a) assay
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x
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min
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=
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3.00
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y
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min
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=
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4.60
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max
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=
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93.80
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max
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=
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97.00
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mean
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=
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18.64
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mean
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=
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19.94
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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 25 mg/dL
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Bilirubin F :
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No interference up to 25 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 1,000 mg/dL
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Plasminogen :
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No interference up to 150 mg/dL
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