hsCRP
High-Sensitive C-Reactive Protein
High-Sensitive CRP
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Cat. No.:
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KAI-160
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Type:
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Reagent
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Method:
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Immunoturbidimetric
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Format:
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Liquid
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Linearity:
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0.20 - 20.0 mg/L
or
0.020 - 2.00 mg/dL
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Sample:
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Serum, Plasma
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KIT COMPOSITION
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INTENDED USE
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For the in vitro quantitative determination of C-reactive protein (CRP) in human serum and plasma
on automated clinical chemistry analyzers. Measurement of CRP is of use for the detection
and evaluation of inflammatory disorders and associated diseases, infection and tissue injury.
For in vitro diagnostic use only.
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REAGENT PREPARATION
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1. The K-ASSAY ® hsCRP reagents are provided ready-to-use.
2. Physiological saline is needed to dilute high CRP samples and is used as a zero calibrator.
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STORAGE AND HANDLING
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The K-ASSAY ® hsCRP
assay reagents should be stored at 2-8°C. DO NOT FREEZE. The reagents are stable when stored as instructed until the expiration date of the label.
Do not mix reagent components from different lots.
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PERFORMANCE
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Precision
The intra-precision of the
K-ASSAY ®
hsCRP Assay was evaluated as follows: in the study, three serum controls containing CRP were tested in duplicates on a Hitachi 917 over 20 days with 2 runs per day.
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Level 1
1 |
Level 2
2 |
Level 3
3 |
Serum
4 |
Serum
4 |
| N |
80 |
80 |
80 |
80 |
20* |
| Mean (mg/L) |
0.85 |
1.75 |
8.62 |
3.62 |
15.56 |
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| Within Run S.D. |
0.03 |
0.03 |
0.06 |
0.05 |
0.19 |
| Within Run C.V. % |
4.0 |
1.7 |
0.7 |
1.4 |
1.2 |
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| Total S.D. |
0.04 |
0.05 |
0.12 |
0.09 |
0.24 |
| Total C.V. % |
4.2 |
2.6 |
1.4 |
2.4 |
1.6 |
*Sample was tested on Hitachi 917 over 5 days with 2 runs per day
Accuracy / Correlation
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y = 1.01x + 0.0196
r = 0.995
x = Company A's CRP assay
y = K-ASSAY ® hsCRP
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Assay Range
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0.2 - 20 mg/L
or
0.02 - 2.0 mg/dL
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INTERFERENCE
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The following substances do not interfere with this assay at the levels tested
(less than 10% basis):
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Ascorbic Acid :
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No interference up to 176 mg/dL
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Bilirubin, Conjugated :
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No interference up to 40 mg/dL
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Bilirubin, Unconjugated :
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No interference up to 40 mg/dL
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Hemoglobin :
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No interference up to 500 mg/dL
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Rheumatoid Factor :
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No interference up to 400 IU/L
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Triglycerides :
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No interference up to 1,000 mg/dL
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