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Serum FDP
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Cat. No.:
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KAI-320
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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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0.2 - 80 µg/mL (or value of highest calibrator)
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Sample:
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Serum
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KIT COMPOSITION
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INTENDED USE
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For the quantitative determination of fibrin / fibrinogen degradation products in human serum.
FOR RESEARCH USE ONLY IN THE U.S.
NOT FOR USE IN DIAGNOSTIC PROCEDURES IN THE U.S.
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REAGENT PREPARATION
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The reagents are ready to use and do not require reconstitution. Before use,
gently invert Reagent 2 at least once a week.
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STORAGE AND HANDLING
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All reagents should be stored refrigerated (2-8°C). Return all reagents to
2-8°C promptly after use. Unopened reagents can be used for 18 months from the
date of manufacture, as indicated by the expiration date on the package and bottle
labels. Opened reagents can be used for one month if stored at 2-8°C.
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PERFORMANCE
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Precision
The following within run precision results were abtained on a Roche/Hitachi analyzer with pooled human serum or urine:
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Sample 1 |
Sample 2 |
| N |
20 |
20 |
| Mean |
3.97 µg/mL |
14.42 µg/mL |
| S.D. |
0.0979 |
0.1725 |
| C.V. |
2.47 % |
1.20 % |
Accuracy / Correlation
A comparison of the
K-ASSAY ®
Serum FDP reagent and another company's Serum FDP reagent was performed with the following results on serum samples:
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Linear Regression:
y = 0.9697x + 0.2924
r = 0.9990
n = 62
x = another company's Serum FDP assay
y = K-ASSAY ® Serum FDP Assay
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Assay Range
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0.2 - 80 µg/mL (or value of highest calibrator)
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INTERFERENCE
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Bilirubin, Conjugated:
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No interference ≤ 20 mg/dL
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Bilirubin, Unconjugated:
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No interference ≤ 20 mg/dL
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Chyle (Formazine Turbidity):
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No interference ≤ 3,000 FTU
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Hemoglobin:
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No interference ≤ 500 mg/dL
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Rheumatoid Factor:
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No interference ≤ 570 IU/mL
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