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K-ASSAY
Since 1983
K-Assay
 
Clinical Diagnostics - Immunoassay Reagents
For Use on Automated Chemistry Analyzers
 
Apo AI / Apolipoprotein AI
Apo A1 / Apolipoprotein A1
Cat. No.: KAI-002
Type: Reagent
Method: Immunoturbidimetric
Format: Liquid
Linearity: 20 - 300 mg/dL
Sample: Serum


KIT COMPOSITION
R1:   3 X 20 mL buffer
R2:   1 X 20 mL antibody

Tests / Kit:   200 (Hitachi 717)
(Can Vary Based On Analyzer Model)
    
KAI-002
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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 AI (Apo AI) 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 AI assay was determined using packaged reagents, pooled human serum, and a Hitachi 704 analyzer.

Precision - Within Run
Sample I Sample II Sample III
N = 20 N = 20 N = 20
Mean = 83.1 Mean = 142.6 Mean = 189.0
S.D. = 1.6 S.D. = 2.3 S.D. = 2.9
C.V. = 1.87% C.V. = 1.60% C.V. = 1.51%

Precision - Between Runs
Sample I Sample II Sample III
N = 10 N = 10 N = 10
Mean = 85.9 Mean = 136.5 Mean = 185.9
S.D. = 1.1 S.D. = 1.437 S.D. = 2.9
C.V. = 1.28% C.V. = 1.05% C.V. = 1.57%

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

y = 0.980x + 4.776
r = 0.970
n = 55
x = Sigma Apo AI Test Kit
y = K-ASSAY ®   Apo AI assay

x min = 91 y min = 89
  max = 200   max = 213
  mean = 146   mean = 147

Assay Range
20 - 300 mg/dL

INTERFERENCE
Bilirubin C :     No interference up to 20 mg/dL
Bilirubin F :     No interference up to 20 mg/dL
Hemoglobin :     No interference up to 500 mg/dL
Intralipid :     No interference up to 2,000 mg/dL