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K-ASSAY
Since 1983
K-Assay
 
Clinical Diagnostics
Immunoassay Reagents
 
Haptoglobin
Cat. No.: KAI-022
Type.: Reagent
Method: Immunoturbidimetric
Format: Liquid
Linearity: 20 - 220 mg/dL
Sample: Serum


KIT COMPOSITION
R1:   3 X 18 mL buffer
R2:   2 X 7 mL antibody

Tests / Kit:   200 (Hitachi 717)
(Can Vary Based On Analyzer Model)
    
KAI-022
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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 haptoglobin in human serum by immunoturbidimetric assay.  Haptoglobin is a protein that binds hemoglobin, the oxygen-carrying pigment in red blood cells.  Measurement of haptoglobin may aid in the diagnosis of hemolytic diseases (diseases in which the red blood cells rupture and release hemoglobin) relating to the formation of hemoglobin-haptoglobin complexes and certain kidney diseases.
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 ®   Haptoglobin 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 = 68.15 Mean = 366
S.D. = 0.88 S.D. = 5.5
C.V. = 1.3% C.V. = 1.5%

Precision - Between Runs
Sample I Sample II
N = 8 N = 8
Mean = 85.9 Mean = 225.6
S.D. = 0.8 S.D. = 1.4
C.V. = 0.972% C.V. = 0.624%

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

y = 0.937x - 9.25
r = 0.993
n = 60
x = Incstar Haptoglobin Test Kit
y = K-ASSAY ®   Haptoglobin assay

x min = 34 y min = 4
  max = 266   max = 267
  mean = 109   mean = 93

Assay Range
20 - 220 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%