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D-Dimer Calibrator
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Cat. No.:
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KAI-091C
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Type:
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Calibrator
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KIT COMPOSITION
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INTENDED USE
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The K-ASSAY ®
D-Dimer Calibrator is intended to be used for the multi-point calibration of the
K-ASSAY ®
D-Dimer assay (Cat. No. KAI-090) for the quantitative determination of cross-linked fibrin degradation products
containing D-Dimer in human plasma or serum.
FOR IN VITRO DIAGNOSTIC USE.
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CALIBRATOR PREPARATION
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1.
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Calibrators are lyophilized and require reconstitution. Add exactly 1.0 mL
of purified water to each vial containing the lyophilized D-Dimer to dissolve it.
Swirl gently to dissolve. The concentration of the dissolved D-Dimer is
indicated on the vial label and may change from lot to lot.
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2.
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Mix before using by gently inverting the bottles.
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3.
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Use the 6 reconstituted calibrators without dilution to make a calibration curve.
Load the 6 calibrators, in order of lowest to highest concentration, on the analyzer.
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STORAGE AND HANDLING
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All calibrators should be stored refrigerated (2-8°C). Return all calibrators
to 2-8°C promptly after use. Unopened calibrators can be used for one year
from the date of manufacturing as indicated by the expiration date on the package and
bottle labels. The reconstituted calibrators are stable for 1 month if stored at 2-8°C.
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CALIBRATOR VALUES
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The following values are given as an example. The expected values for the
K-ASSAY ®
D-Dimer Calibrator are continually being revised through ongoing quality assurance.
As a result, the expected values may change from lot to lot. Please refer to the
package insert for each lot for the exact calibrator values.
| Calibrator 1 |
0.00 µg/mL DDU |
| Calibrator 2 |
2.21 µg/mL DDU |
| Calibrator 3 |
4.38 µg/mL DDU |
| Calibrator 4 |
7.46 µg/mL DDU |
| Calibrator 5 |
14.96 µg/mL DDU |
| Calibrator 6 |
29.74 µg/mL DDU |
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