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K-ASSAY
Since 1983
K-Assay
 
Clinical Diagnostics
Immunoassay Reagents
 
Apo B
Apolipoprotein B
Cat. No.: KAI-004   or   KAI-024
Type.: Reagent
Method: Immunoturbidimetric
Format: Liquid
Linearity: 25 - 250 mg/dL
Sample: Serum


KIT COMPOSITION
Cat. No. KAI-004
R1:   3 X 20 mL buffer
R2:   1 X 20 mL antibody

Tests / Kit:   200 (Hitachi 717)
(Can Vary Based On Analyzer Model)
    
KAI-004
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-024
Note: Large size kit, available by special order.
R1:   3 X 60 mL buffer
R2:   1 X 60 mL antibody

Tests / Kit:   600 (Hitachi 717)
(Can Vary Based On Analyzer Model)

    
KAI-024
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 Apolipoprotein B (Apo B) in serum by immunoturbidimetric assay.
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 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 ®   Apo B 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 = 36.0 Mean = 70.2 Mean = 120.2
S.D. = 0.7 S.D. = 1.5 S.D. = 1.7
C.V. = 2.06% C.V. = 2.12% C.V. = 1.44%

Precision - Between Runs
Sample I Sample II Sample III
N = 10 N = 10 N = 10
Mean = 58.6 Mean = 83.3 Mean = 124.5
S.D. = 1.3 S.D. = 1.9 S.D. = 1.4
C.V. = 2.25% C.V. = 2.33% C.V. = 1.09%

Accuracy / Correlation
A comparison of the K-ASSAY ®   Apo B assay and a Sigma Apo B Test Kit was performed using a Hitachi 704.  The test results provided the following data:

y = 1.442x + 0.00
r = 0.885
n = 50
x = Sigma Apo B Test Kit
y = K-ASSAY ®   Apo B assay

x min = 26 y min = 42
  max = 106   max = 175
  mean = 65   mean = 107

Assay Range
25 - 250 mg/dL

INTERFERENCE
Bilirubin F and C :     No interference up to 20 mg/dL
Hemoglobin :     No interference up to 500 mg/dL
Lipemia :     No interference up to 20% volume of Intralipid ® 10%