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Ferritin
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Cat. No.:
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KAI-095
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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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2.0 - 1,000 ng/mL
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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 ®
Ferritin assay is an in vitro diagnostic reagent for the
quantitative determination of ferritin (an iron-storing protein) in human serum and plasma by
immunoturbidimetric assay on the Roche / Hitachi 917 and other analyzers. Measurements
of ferritin aid in the diagnosis of diseases affecting iron overload and iron
deficiency anemia.
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 18 months 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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Serum samples were assayed 21 times on the same day.
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Sample I
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Sample II
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Sample III
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N = 21
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N = 21
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N = 21
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Mean = 14.9
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Mean = 100.0
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Mean = 431.1
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Low = 13.8
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Low = 98.7
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Low = 427.6
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High = 15.9
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High = 101.2
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High = 435.5
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S.D. = 0.600
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S.D. = 0.647
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S.D. = 2.203
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C.V. = 4.03%
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C.V. = 0.65%
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C.V. = 0.51%
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Precision - Between Runs
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Serum samples were assayed on 20 different days.
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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 = 16.5
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Mean = 105.2
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Mean = 428.7
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Low = 15.4
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Low = 102.7
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Low = 421.0
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High = 18.1
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High = 107.6
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High = 432.6
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S.D. = 0.733
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S.D. = 1.522
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S.D. = 2.510
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C.V. = 4.45%
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C.V. = 1.45%
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C.V. = 0.59%
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Accuracy / Correlation
A comparison of the
K-ASSAY ®
Ferritin and another company's Ferritin on the Hitachi 917 was performed with the following results. Statistics were calculated by
linear regression. Samples used in the correlation study were serum samples from Asian patients.
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y = 0.89x - 9.4037
r = 0.997
n = 64
x = another comapny's Ferritin assay
y = K-ASSAY ® Ferritin assay
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Assay Range
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INTERFERENCE
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Bilirubin F and C :
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No interference up to 62 mg/dL
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Hemoglobin :
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No interference up to 1,040 mg/dL
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Lipid :
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No interference up to 3% Intra-fat (which contains 10% soybean oil);
no interference up to 5% Intra-lipid (which contains 10% soybean oil,
different manufacturer)
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Rheumatoid Factor :
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No interference up to 520 IU/mL
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