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KIT COMPOSITION
KAI-082
Reagent 1 (R-1) Buffer Reagent 1 x 50 ml
Reagent 2 (R-2) Antiserum Reagent 1 x 50 ml
PERFORMANCE
Precision
Samples tested were commercial human CRP control serum.
Precision Assay: Within Run with CRP (3) Calibrator D
| Sample I |
Sample II |
Sample III |
N = 20
Mean = 0.48
SD = 0.02
CV = 4.3%
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N = 20
Mean = 2.42
SD = 0.04
CV = 1.6%
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N = 20
Mean = 9.80
SD = 0.09
CV = 0.87%
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Precision Assay: Between Run with CRP (3) Cal. D
CRP values were tested on 21 days.
| Sample I |
Sample II |
Sample III |
N = 21
Mean = 0.5
SD = 0.03
CV = 6.97%
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N = 21
Mean = 2.2
SD = 0.07
CV = 3.35%
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N = 21
Mean = 9.8
SD = 0.12
CV = 1.23%
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Assay Range
0.1 - 320 mg/L (Standard Protocol)
0.05 - 160 mg/L (High Sensitivity Protocol)
0.2 - 480 mg/L (Wide Sensitivity Protocol)
Correlation
Y
r
X
Y
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=
1.012x + 0.0051
= 0.999
= company A's latex hsCRP
nephelometric assay
= K-ASSAY ITA CRP(3)
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INTERFERENCE
Bilirubin C
Bilirubin F
Hemoglobin
Lipid |
No interference up to 30 mg/dl
No interference up to 30 mg/dl
No interference up to 500 mg/dl
No interference up to 3000 mg/dl Interfat |
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Tel: (206) 575-8068