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K-ASSAY
Since 1983
K-Assay
 
Clinical Diagnostics
Immunoassay Reagents
 
Total IgE
Cat. No.: KAI-092
Type.: Reagent
Method: Immunoturbidimetric
Format: Liquid
Linearity: 10 - 2,000 IU/mL   (or value of highest calibration point)
Sample: Serum, Plasma


KIT COMPOSITION
R1:   2 X 20 mL buffer
R2:   1 X 6.6 mL antibody

Tests / Kit:   220 (Hitachi 917)
(Can Vary Based On Analyzer Model)
    
KAI-092
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
The K-ASSAY ®   Total IgE is an in vitro diagnostic reagent for the quantitative determination of circulating total IgE in human serum or plasma by immunoturbidimetric assay for use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings.
FOR IN VITRO DIAGNOSTIC USE.

REAGENT PREPARATION
The reagents are ready to use.  They do not need to be reconstituted.  Mix before using by gently inverting the bottles.  After opening, gently invert Reagent 2 once a week.

STORAGE AND HANDLING
All reagents should be stored refrigerated (2-8°C) and protected from light.  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 ®   Total IgE assay was determined using packaged reagents, pooled human serum, and a Hitachi 917 analyzer.

Precision - Within Run
Sample I Sample II Sample III Sample IV Sample V
N = 10 N = 10 N = 10 N = 10 N = 10
Mean = 105.3 Mean = 174.1 Mean = 350.5 Mean = 1,117.8 Mean = 1,908.6
S.D. = 1.06 S.D. = 2.85 S.D. = 7.68 S.D. = 13.26 S.D. = 30.25
C.V. = 1.01% C.V. = 1.63% C.V. = 2.2% C.V. = 1.2% C.V. = 1.6%

Precision - Between Runs
Sample I Sample II Sample III Sample IV Sample V
N = 10 N = 10 N = 10 N = 10 N = 10
Mean = 105.4 Mean = 177.6 Mean = 663.7 Mean = 2,147.5 Mean = 3,304.7
S.D. = 2.72 S.D. = 3.24 S.D. = 11.22 S.D. = 33.56 S.D. = 16.67
C.V. = 2.58% C.V. = 1.82% C.V. = 1.69% C.V. = 1.56% C.V. = 0.50%

Accuracy / Correlation
A comparison of the K-ASSAY ®   Total IgE assay and Company X's Total IgE reagent was performed with the following results:

y = 0.9851x + 10.618
r = 0.9928
n = 80
x = Company X's Total IgE
y = K-ASSAY ®   Total IgE

Assay Range
10 - 2,000 IU/mL   (or value of highest calibration point)

INTERFERENCE
Bilirubin F :     No interference up to 18.5 mg/dL
Bilirubin C :     No interference up to 21.6 mg/dL
Hemoglobin :     No interference up to 467 mg/dL
RF :     No interference up to 500 IU/mL
Sodium Citrate :     No interference up to 15 mg/mL
Sodium Heparin :     No interference up to 150 IU/mL
EDTA-2Na :     No interference up to 1.5 mg/mL
Chyle (Formazine Turbidity) :     No interference up to 2,120