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K-ASSAY
Since 1983
K-Assay
 
Clinical Diagnostics
Immunoassay Reagents
 
Ferritin
Cat. No.: KAI-095   or   KAI-046
Type.: Reagent
Method: Immunoturbidimetric
Format: Liquid
Linearity: 2.0 - 1,000 ng/mL
Sample: Serum, Plasma


KIT COMPOSITION
Cat. No. KAI-095
R1:   1 X 18 mL buffer
R2:   1 X 9 mL antibody

Tests / Kit:   111 (Hitachi 717)
(Can Vary Based On Analyzer Model)
    
KAI-095
Click Image To Enlarge       

Click here for an example package insert.

Click here for the Safety Data Sheets (SDS):
Reagent-1 (R-1)
Reagent-2 (R-2)

Click here for information about recommended calibrators and controls.




Cat. No. KAI-046
Note: Large size kit, available by special order.
R1:   2 X 41 mL buffer
R2:   2 X 20 mL antibody

Tests / Kit:   500 (Hitachi 717)
(Can Vary Based On Analyzer Model)

    
KAI-046
Click Image To Enlarge       

Click here for an example package insert.

Click here for the Safety Data Sheets (SDS):
Reagent-1 (R-1)
Reagent-2 (R-2)

Click here for information about recommended calibrators and controls.


INTENDED USE
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.

REAGENT PREPARATION
The reagents are ready to use and do not require reconstitution.

STORAGE AND HANDLING
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.

PERFORMANCE
Precision
The precision for the K-ASSAY ®   Apo B assay was determined using packaged reagents, pooled human serum, and a Hitachi 717 analyzer.

Precision - Within Run
Serum samples were assayed 21 times on the same day.
Sample I Sample II Sample III
N = 21 N = 21 N = 21
Mean = 14.9 Mean = 100.0 Mean = 431.1
Low = 13.8 Low = 98.7 Low = 427.6
High = 15.9 High = 101.2 High = 435.5
S.D. = 0.600 S.D. = 0.647 S.D. = 2.203
C.V. = 4.03% C.V. = 0.65% C.V. = 0.51%

Precision - Between Runs
Serum samples were assayed on 20 different days.
Sample I Sample II Sample III
N = 20 N = 20 N = 20
Mean = 16.5 Mean = 105.2 Mean = 428.7
Low = 15.4 Low = 102.7 Low = 421.0
High = 18.1 High = 107.6 High = 432.6
S.D. = 0.733 S.D. = 1.522 S.D. = 2.510
C.V. = 4.45% C.V. = 1.45% C.V. = 0.59%

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.

y = 0.89x - 9.4037
r = 0.997
n = 64
x = another comapny's Ferritin assay
y = K-ASSAY ®   Ferritin assay

Assay Range
2.0 - 1,000 ng/mL

INTERFERENCE
Bilirubin F and C :      No interference up to 62 mg/dL
Hemoglobin :      No interference up to 1,040 mg/dL
Lipid :      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)
Rheumatoid Factor :      No interference up to 520 IU/mL