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K-ASSAY
Since 1983
K-Assay
 
Clinical Diagnostics
Immunoassay Reagents
 
Alpha-1 AG
Alpha-1 Acid Glycoprotein
Cat. No.: KAI-021
Type.: Reagent
Method: Immunoturbidimetric
Format: Liquid
Linearity: 10 - 200 mg/dL
Sample: Serum


KIT COMPOSITION
R1:   3 X 20 mL buffer
R2:   2 X 7 mL antibody

Tests / Kit:   200 (Hitachi 717)
(Can Vary Based On Analyzer Model)
    
KAI-021
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 alpha-1 acid glycoprotein (alpha-1 AG) in human serum by immunoturbidimetric assay.  Measurement of alpha-1 acid glycoprotein may aid in the diagnosis of collagen (connective tissue) disorders, tuberculosis, infections, extensive malignancy, and diabetes.
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 ®   Alpha-1 AG 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 = 32.5 Mean = 92.3 Mean = 233.7
S.D. = 0.53 S.D. = 0.6 S.D. = 2.17
C.V. = 1.6% C.V. = 0.7% C.V. = 0.9%

Precision - Between Runs
Sample I Sample II Sample III
N = 10 N = 10 N = 10
Mean = 54.6 Mean = 104.7 Mean = 198.6
S.D. = 0.69 S.D. = 0.93 S.D. = 1.37
C.V. = 1.27% C.V. = 0.89% C.V. = 0.69%

Accuracy / Correlation
A comparison of the K-ASSAY ®   Alpha-1 AG assay and a Binding Site Alpha-1 AG RID Test Kit was performed using a Hitachi 717.  The test results provided the following data:

y = 1.016x + 3.547
r = 0.995
n = 37
x = Binding Site Alpha-1 AG RID
y = K-ASSAY ®   Alpha-1 AG assay

x min = 35 y min = 37
  max = 195   max = 201
  mean = 74   mean = 79

Assay Range
10 - 200 mg/dL

INTERFERENCE
Ascorbic Acid :     No interference up to 200 mg/dL
Bilirubin F and C :     No interference up to 20 mg/dL
Hemoglobin :     No interference up to 500 mg/dL
Lipemia :     No interference up to 4%