High-Sensitive D-Dimer Calibrator
( NOT FOR USE IN THE U.S. )
|
|
Cat. No.:
|
KAI-103C
|
|
Type.:
|
Calibrator
|
|
|
KIT COMPOSITION
|
|
Lyophilized Human D-Dimer
|
5 x 2.4 mL
|
|
Diluent (Tris-HCl solution)
|
2 x 40 mL
|
|
|
Click Image To Enlarge
|
|
|
INTENDED USE
|
The K-ASSAY ®
High-Sensitive D-Dimer Calibrator is intended to be used for the multi-point calibration of the
K-ASSAY ®
High-Sensitive D-Dimer assay (Cat. No. KAI-102).
NOT FOR USE IN THE U.S.
|
|
CALIBRATOR PREPARATION
|
|
1.
|
Add exactly 2.4 mL of diluent to a vial containing the lyophilized D-Dimer to dissolve it and allow to sit for 30 minutes.
Swirl gently to dissolve.
|
|
|
2.
|
Prepare 6 calibrators (A-F) using the dissolved stock and diluent. See product
package insert for details.
|
|
|
STORAGE AND HANDLING
|
All stock calibrators and diluent 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. Reconstituted and diluted calibrators can be used for 6 hours if stored
at room temperature (18-25°C). Reconstituted stock calibrators (not diluted) can be
frozen one time and stored at -20°C for up to 1 month. Do not refreeze a second time.
Unopened diluent can be used for 2 years from the date of manufacturing as indicuated by the expiration
date on the package and bottle labels. Opened diluent can be used up to the expiration date provided
that the cap is tightly closed to prevent evaporation and the solution is not contaminated.
|
|
CALIBRATOR VALUES
|
The following values are given as an example. The expected values for the
K-ASSAY ®
High-Sensitive 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.
Concentration of lyophilized Human D-Dimer, reconstitued with 2.4 mL of diluent :
|
ng/mL DDU
|
µg/mL DDU
|
|
8,000
|
8.0
|
After reconstitution and dilution :
|
Calibrators A-F
|
|
A |
B |
C |
D |
E |
F |
| ng/mL DDU |
0 |
500 |
1,000 |
2,000 |
4,000 |
8,000 |
| µg/mL DDU |
0.0 |
0.5 |
1.0 |
2.0 |
4.0 |
8.0 |
|
