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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 C4 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 = 5.7
SD = 0.29
CV = 5.17%
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N = 20
Mean = 36.3
SD = 0.76
CV = 2.1%
|
N = 20
Mean = 58.6
SD = 1.98
CV = 3.38%
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Precision Assay: Between Runs
| Sample I |
Sample II |
Sample III |
N = 10
Mean = 6.51
SD = 0.24
CV = 3.72%
|
N = 10
Mean = 30.6
SD = 1.18
CV = 3.87%
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N = 10
Mean = 53.2
SD = 1.12
CV = 2.1%
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Correlation
A comparison of the K-ASSAY C4 assay and an Incstar C4 Test Kit was performed
using a Hitachi 717. The test results provided the following data:
Y
r
n
X
Y
|
= 0.739X + 2.46
= 0.988
= 60
= Incstar C4 Test Kit
= K-ASSAY C4 assay
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| X min |
= 11 |
Y min
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= 9
|
| max |
= 56 |
max
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= 45
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| mean |
= 31 |
mean
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= 25
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Assay Range
8-80 mg/dl (multi-point calibration)
INTERFERENCE
Bilirubin F and C
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