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Insulin Calibrator
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Cat. No.:
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KAI-072C
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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 ®
Insulin Calibrator is intended to be used for the calibration of the
K-ASSAY ®
Insulin assay (Cat. No. KAI-040 or KAI-071).
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 0.5 mL
of purified water to each vial containing the lyophilized serum to dissolve it.
Swirl gently to dissolve. The concentration of the dissolved serum is
indicated on the vial label and may change from lot to lot.
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2.
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Allow the vial to sit at room temperature (18-26 °C) for 15 minutes prior to use.
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3.
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Mix before using by gently inverting the bottles.
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4.
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Use the 5 reconstituted calibrators without dilution and purified water for the zero
calibrator (0 µIU/mL) to make a calibration curve. Load the 6 calibrators
from 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 on the expiration date on the package and
bottle labels. Opened bottles of calibrators can be used for 2 weeks 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 ®
Insulin 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 |
4.2 µIU/mL |
| Calibrator 2 |
9.9 µIU/mL |
| Calibrator 3 |
25.6 µIU/mL |
| Calibrator 4 |
52.1 µIU/mL |
| Calibrator 5 |
101.3 µIU/mL |
Note: Purified water should be used for Calibrator 0. (0.0 µIU/mL)
Values are traceable to the Human Insulin for Immunoassay International Reference
Preparation, NIBSC Code 66/304.
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