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Serum/Urine FDP-E
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Cat. No.:
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KAI-113
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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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Serum :
22 - 1,920 ng/mL (or value of highest calibrator)
Urine :
6 - 192 ng/mL (or value of highest calibrator)
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Sample:
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Serum,Urine
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KIT COMPOSITION
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INTENDED USE
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For the quantitative determination of fibrin / fibrinogen degradation product fragment E (FDP-E) in human serum and urine.
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 (serum) or Roche/Cobas Mira (urine) with pooled human serum or urine:
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Serum |
| Sample 1 |
Sample 2 |
| N |
10 |
10 |
| Mean |
287.3 ng/mL |
878.8 ng/mL |
| S.D. |
6.783 |
14.726 |
| C.V. |
2.36 % |
1.68 % |
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Urine |
| Sample 1 |
Sample 2 |
| N |
10 |
10 |
| Mean |
20.7 ng/mL |
84.8 ng/mL |
| S.D. |
0.565 |
1.519 |
| C.V. |
2.73 % |
1.79 % |
Accuracy / Correlation
Serum
A comparison of the
K-ASSAY ®
Serum/Urine FDP-E reagent and another company's FDP-E reagent was performed with the following results on serum samples:
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Linear Regression:
y = 0.9167x + 16.69
r = 0.9955
n = 80
x = another company's serum FDP-E assay
y = K-ASSAY ® Serum/Urine FDP-E Assay
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Urine
A comparison of the
K-ASSAY ®
Serum/Urine FDP-E reagent and another company's Urine FDP reagent was performed with the following results on urine samples:
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Linear Regression:
y = 1.0342x - 1.999
r = 0.9916
n = 52
x = another company's urine FDP-E assay
y = K-ASSAY ® Serum/Urine FDP-E Assay
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Assay Range
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Serum :
22 - 1,920 ng/mL (or value of highest calibrator)
Urine :
6 - 192 ng/mL (or value of highest calibrator)
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INTERFERENCE
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Serum
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Bilirubin C:
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No interference ≤ 19.6 mg/dL
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Bilirubin F:
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No interference ≤ 18.2 mg/dL
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Chyle (Formazine Turbidity):
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No interference ≤ 2,400 FTU
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Hemoglobin :
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No interference ≤ 460 mg/dL
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Rheumatoid Factor:
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No interference ≤ 480 IU/mL
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