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K-ASSAY
Since 1983
K-Assay
 
Clinical Diagnostics
Immunoassay Reagents
 
Prealbumin
Cat. No.: KAI-053
Type.: Reagent
Method: Immunoturbidimetric
Format: Liquid
Linearity: 0 - 60 mg/dL
Sample: Serum


KIT COMPOSITION
R1:   4 X 20 mL buffer
R2:   2 X 8 mL antibody

Tests / Kit:   320 (Hitachi 717)
(Can Vary Based On Analyzer Model)
    
KAI-053
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
For the quantitative determination of human prealbumin in serum by immunoturbidimetric assay.
FOR IN VITRO DIAGNOSTIC USE.

REAGENT PREPARATION
The reagents are ready to use.  They do not need to be reconstituted.

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 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.

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

Precision - Within Run
Sample I Sample II Sample III
N = 20 N = 20 N = 20
Mean = 11.2 Mean = 24.9 Mean = 57.0
S.D. = 0.145 S.D. = 0.289 S.D. = 0.767
C.V. = 1.29% C.V. = 1.16% C.V. = 1.35%

Accuracy / Correlation
A comparison of the K-ASSAY ®   Prealbumin assay and an similar Prealbumin assay was performed using a Hitachi 717.  The test results provided the following data:

y = 0.9164x - 0.332
r = 0.9924
n = 50
x = Similar Prealbumin assay
y = K-ASSAY ®   Prealbumin assay

x min = 5.7 y min = 4.2
  max = 43.2   max = 38.4
  mean = 22.89   mean = 20.64

Assay Range
0 - 60 mg/dL

INTERFERENCE
Bilirubin F and C :     No interference up to 20 mg/dL
Hemoglobin :     No interference up to 470 mg/dL
Lipemia :     No interference up to 5%