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Coagulation Control
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Cat. No.:
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K104C-10M
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Type.:
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Control
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KIT COMPOSITION
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INTENDED USE
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The K-ASSAY ®
Coagulation Control is intended to be used as a consistent test sample of known concentration for monitoring
the performance of K-ASSAY ®
coagulation assays for the listed constituents.
Factor XIII (Cat. No. KAI-105)
FDP, Serum and Urine (Cat. No. KAI-107)
FDP, Plasma (Cat. No. KAI-111)
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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Reconstitue 1 vial of each control level with 0.5 mL of purified water and allow to sit for 30 minutes.
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2.
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Gently swirl vial until dissolution is complete and the solution is homogenous (do not shake).
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3.
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Replace the cap immediately after use to prevent evaporation or contamination.
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4.
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Return the vial to 2-8°C prompty after use.
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STORAGE AND HANDLING
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Store lyophilized and reconstituted controls at 2-8°C. Return all controls to 2-8°C promptly after use.
Unopened controls can be used for 2 years from the date of manufacturing as indicated by the expiration date on the package
and bottle labels.
Reconstituted controls can be used for up to 7 days if stored at 2-8°C.
Reconstituted controls can be frozen one time and stored at -20°C for up to 5 weeks. Do not refreeze a second time.
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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 ®
Coaugulation 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 |
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LEVEL 1 |
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LEVEL 2 |
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Units |
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MEAN |
RANGE |
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MEAN |
RANGE |
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D-Dimer
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3.37 |
2.70 - 4.04 |
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15.17 |
12.14 - 18.20 |
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µg/mL
(DDU) |
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Factor XIII
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96.9 |
81.4 - 112.4 |
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51.6 |
43.3 - 59.9 |
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% |
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Serum FDP
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5.07 |
3.80 - 6.34 |
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26.37 |
19.78 - 32.96 |
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µg/mL |
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Plasma FDP
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5.7 |
4.3 - 7.1 |
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22.8 |
17.1 - 28.5 |
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µg/mL |
Urine FDP
(after diluting control 1/13
with Serum/Urine FDP
Calibrator Diluent)
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0.49 |
0.27 - 0.71 |
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2.02 |
1.11 - 2.93 |
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µg/mL |
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Serum FDP-E
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287 |
215 - 359 |
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1,093 |
820 - 1,366 |
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ng/mL |
Urine FDP-E
(after diluting control
1/10 with saline)
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27.4 |
15.1 - 39.7 |
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107.3 |
59.0 - 155.6 |
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ng/mL |
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