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KIT COMPOSITION
Reagent 1 (R-1) Buffer Reagent 4 x 20 ml
Reagent 2 (R-2) Antiserum Reagent 4 x 20 ml
PERFORMANCE
Precision
Precision Assay: Within Run
| Serum I |
Serum II |
Serum III |
N = 20
Mean = 901
SD = 16.9
CV = 1.9%
|
N = 20
Mean = 1883
SD = 30.0
CV = 1.6%
|
N = 20
Mean = 2927
SD = 78.1
CV = 2.7%
|
Precision Assay: Between Runs
| Serum I |
Serum II |
Serum III |
N = 7
Mean = 437
SD = 13.4
CV = 3.1%
|
N = 7
Mean = 1500
SD = 20.9
CV = 1.4%
|
N = 7
Mean = 2002
SD = 28.2
CV = 1.4%
|
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Assay Range
100 - 4,500 mg/dl (multi-point calibration)
Correlation
A comparison of this K-ASSAY IgG and an Incstar IgG Test Kit was performed on a Hitachi
704 automated analyzer and a COBAS Mira. The test results provided the following data:
Y
r
n
|
= 1.0789x - 88.01
= 0.99322
= 46
|
INTERFERENCE
Bilirubin
Hemoglobin
Lipemia
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No interference up to 20 mg/dl
No interference up to 500 mg/dl
No interference up to 5%
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Tel: (206) 575-8068