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KIT COMPOSITION
Reagent 1 (R-1) Buffer Reagent 2 x 20 ml
Reagent 2 (R-2) Antiserum Reagent 1 x 6.6 ml
PERFORMANCE
Precision
Precision Assay: Within Run
| Sample |
I |
II |
III |
IV |
III |
N
Mean, IU/ml
SD
CV, %
|
10
105.3
1.06
1.01
|
10
174.1
2.85
1.63
|
10
350.5
7.68
2.2
|
10
1117.8
13.26
1.2
|
10
1908.6
30.25
1.6
|
Precision Assay: Between Runs
| Sample |
I |
II |
III |
IV |
III |
N
Mean, IU/ml
SD
CV, %
|
10
105.4
2.72
2.58
|
10
177.6
3.24
1.82
|
10
663.7
11.22
1.69
|
10
2147.5
33.56
1.56
|
10
3304.7
16.67
0.50
|
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Assay Range
10 - 2000 IU/ml (or value of highest calibrator)
Correlation
A comparison of the K-ASSAY Total IgE reagent and the Company X's
Total IgE reagent was performed with the following results::
Y
r
n
X
Y
|
=
0.9851x + 10.618
= 0.9928
= 80
= Company X's Total IgE
= K-ASSAY
IgE
|
INTERFERENCE
Bilirubin F
Bilirubin C
Hemoglobin
RF
Sodium Citrate
|
No interference up to 18.5 mg/dl
No interference up to 21.6 mg/dl
No interference up to 467 mg/dl
No interference up to 500 IU/ml
No interference up to 15 mg/ml
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Tel: (206) 575-8068