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K-ASSAY
Since 1983
K-Assay
 
Clinical Diagnostics
Immunoassay Reagents
 
Alpha-1 AT
Alpha-1 Anti-Trypsin
Cat. No.: KAI-001
Type.: Reagent
Method: Immunoturbidimetric
Format: Liquid
Linearity: 30 - 325 mg/dL
Sample: Serum


KIT COMPOSITION
R1:   3 X 20 mL buffer
R2:   2 X 10 mL antibody

Tests / Kit:   200 (Hitachi 717)
(Can Vary Based On Analyzer Model)
    
KAI-001
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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 alpha-1 anti-trypsin (Alpha-1 AT) in human serum by immunoturbidimetric assay.  Alpha-1 anti-trypsin aids in the diagnosis of several conditions including juvenile and adult cirrhosis of the liver.  In addition, alpha-1 anti-trypsin deficiency has been associated with pulmonary emphysema.
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 AT assay was determined using packaged reagents, pooled human serum, and a Hitachi 717 analyzer.

Precision - Within Run
Sample I Sample II
N = 20 N = 20
Mean = 136 Mean = 343
S.D. = 3.13 S.D. = 4.35
C.V. = 2.3% C.V. = 1.27%

Precision - Between Runs
Sample I Sample II
N = 10 N = 10
Mean = 152 Mean = 355
S.D. = 2.58 S.D. = 2.45
C.V. = 1.70% C.V. = 0.69%

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

y = 0.708x + 12.165
r = 0.942
n = 50
x = Binding Site Alpha-1 AT RID
y = K-ASSAY ®   Alpha-1 AT assay

x min = 86 y min = 69
  max = 276   max = 213
  mean = 208   mean = 160

Assay Range
30 - 325 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 5%