High-Sensitive D-Dimer
( NOT FOR USE IN THE U.S. )
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Cat. No.:
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KAI-102
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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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30 - 8,000 ng/mL DDU
or
0.030 - 8.000 µg/mL DDU
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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 quantitative determination of cross-linked fibrin degrdation products containing
D-dimer in human plasma or serum.
NOT FOR USE 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 within-run, between-run, and total precision for the
K-ASSAY ®
High-Sensitive D-Dimer assay was determined using packaged reagents, human serum samples and controls, and a Roche / Hitachi 902 analyzer in accordance with CLSI EP5-A2.
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Sample 1 |
Sample 2 |
Sample 3 |
Sample 4 |
Sample 5 |
| N |
80 |
80 |
80 |
80 |
80 |
| Mean (ng/mL) |
178.7 |
923.4 |
2,632.0 |
5,456.3 |
6,616.4 |
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| Within Run S.D. |
10.7 |
14.4 |
30.7 |
113.6 |
176.8 |
| Within Run C.V. |
6.0 % |
1.6 % |
1.2 % |
2.1 % |
2.7 % |
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| Between Runs S.D. |
10.2 |
18.6 |
39.5 |
92.1 |
77.2 |
| Between Runs C.V. |
5.7 % |
2.0 % |
1.5 % |
1.7 % |
1.2 % |
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| Total S.D. |
10.4 |
30.0 |
45.9 |
173.2 |
245.0 |
| Total C.V. |
5.8 % |
3.2 % |
1.7 % |
3.2 % |
3.7 % |
Accuracy / Correlation
Testing was performed on a Roche / Hitachi 902 analyzer using unaltered, human citrated plasma samples and in
accordance with the CLSI EP9-A2 guideline. A comparison of the
K-ASSAY ®
High-Sensitive D-Dimer and Company X's D-Dimer assay was performed with the following results:
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Linear Regression:
y = 0.6292x - 114.4416
r = 0.9944
n = 88
x = Company X's D-Dimer
y = K-ASSAY ® High-Sensitive D-Dimer
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Assay Range
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30 - 8,000 ng/mL DDU
or
0.030 - 8.000 µg/mL DDU
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INTERFERENCE
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Testing was performed on a Roche / Hitachi 902 analyzer in accordance with
the CLSI EP7-A2 guideline with the following results.
Criteria: Recovery within ± 10% of initial value
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Bilirubin C:
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No interference ≤ 200 mg/dL
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Bilirubin F:
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No interference ≤ 180 mg/dL
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Chyle:
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No interference ≤ 1,500 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 ≤ 500 IU/mL
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