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Plasma Control
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Cat. No.:
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K81C-6M
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Type.:
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Control
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KIT COMPOSITION
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Level 1
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Human Plasma
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3 x 0.5 mL, lyophilized
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Level 2
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Human Plasma
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3 x 0.5 mL, lyophilized
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Click Image To Enlarge
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INTENDED USE
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The K-ASSAY ®
Plasma Control is intended to be used as a consistent test sample of known concentration for monitoring
the performance of D-Dimer and Plasminogen assays.
FOR IN VITRO DIAGNOSTIC USE.
Values for AT-III, α2PI, and FDP are for research use only in the U.S. Not for use in diagnostic
procedures in the U.S.
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CONTROL PREPARATION
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1.
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Reconstitute Plasma Control with 0.5 mL of distilled water.
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2.
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Gently invert vial until dissolution is complete (do not shake).
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3.
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Allow the vial to sit at room temperature (18-26°C) for 25 minutes prior to use.
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4.
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Replace the cap immediately after use to prevent evaporation or contamination.
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5.
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Return the vial to 2-8°C promptly after use.
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STORAGE AND HANDLING
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Store controls at 2-8°C. Return all controls to 2-8° promptly after use.
Reconstituted controls can be used up to a week if kept at 2-8°C and a month at -20°C
(with 1 time thawing only).
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EXPECTED VALUES
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The following values are given as an example. The expected values for the
K-ASSAY ®
Plasma Control 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 and/or vial labels for each lot for the expected values.
| ANALYTE |
UNIT |
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LEVEL 1 |
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LEVEL 2 |
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MEAN |
RANGE |
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MEAN |
RANGE |
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K-ASSAY ® D-Dimer (KAI-090)
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µg/mL |
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1.11 |
0.89 - 1.33 |
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12.66 |
10.12 - 15.19 |
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AT-III (Antigen)*
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mg/dL |
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28.5 |
23.4 - 33.6 |
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14.6 |
12.4 - 16.8 |
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α2PI (Activity) *
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% |
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89.5 |
72.4 - 106.6 |
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46.4 |
34.7 - 58.1 |
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FDP (Antigen) *
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µg/mL |
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6.5 |
5.4 - 7.6 |
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30.8 |
24.7 - 36.9 |
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Plasminogen (Activity)
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% |
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90.3 |
79.8 - 100.8 |
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50.2 |
40.2 - 60.2 |
* For research use only in the U.S.
Not for diagnostic procedures in the U.S.
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