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KIT COMPOSITION
Reagent 1 (R-1) Buffer Reagent 4 x 20 ml
Reagent 2 (R-2) Antiserum Reagent 2 x 10 ml
PERFORMANCE
Precision
The precision for the K-ASSAY C3 assay was determined using packaged reagents, pooled human serum,
and a Hitachi 717 analyzer.
Precision Assay: Within Run
| Sample I |
Sample II |
Sample III |
N = 20
Mean = 33.7
SD = 1.12
CV = 3.33%
|
N = 20
Mean = 75.6
SD = 1.68
CV = 2.22%
|
N = 20
Mean = 112.4
SD = 2.18
CV = 1.94%
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Precision Assay: Between Runs
| Sample I |
Sample II |
Sample III |
N = 10
Mean = 35.4
SD = 1.29
CV = 3.63%
|
N = 10
Mean = 84.3
SD = 1.95
CV = 2.31%
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N = 10
Mean = 114.4
SD = 1.70
CV = 1.48%
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Correlation
A comparison of the K-ASSAY C3 assay and an Incstar C3 Test Kit was performed
using a Hitachi 717. The test results provided the following data:
Y
r
n
X
Y
|
= 0.842X + 4.727
= 0.925
= 60
= Incstar C3 Test Kit
= K-ASSAY C3 assay
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| X min |
= 78 |
Y min
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= 74
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| max |
= 188 |
max
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= 171
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| mean |
= 135 |
mean
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= 118
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Assay Range
30-350 mg/dl (multi-point calibration)
INTERFERENCE
Bilirubin F and C
Hemoglobin
Lipemia
|
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