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K-ASSAY
Since 1983
K-Assay
Clinical Diagnostics
Immunoassay Reagents
 
High-Sensitive D-Dimer
( NOT FOR USE IN THE U.S. )
Cat. No.: KAI-102
Type.: Reagent
Method: Immunoturbidimetric
Format: Liquid
Linearity: 30 - 8,000 ng/mL DDU
or
0.030 - 8.000 µg/mL DDU
Sample: Serum, Plasma


KIT COMPOSITION
Cat. No. KAI-102
R1:   2 X 18 mL buffer
R2:   1 X 7 mL antibody

Tests / Kit:   175 (Hitachi 717)
(Can Vary Based On Analyzer Model)
    
KAI-102
Click Image To Enlarge       

Click here for an example package insert.

Click here for the Safety Data Sheets (SDS):
Reagent-1 (R-1)
Reagent-2 (R-2)

Click here for information about recommended calibrators and controls.


INTENDED USE
For the quantitative determination of cross-linked fibrin degrdation products containing D-dimer in human plasma or serum.

NOT FOR USE IN THE U.S.

REAGENT PREPARATION
The reagents are ready to use and do not require reconstitution.  Before use, gently invert Reagent 2 at least once a week.

STORAGE AND HANDLING
All reagents should be stored refrigerated (2-8°C).  Return all reagents to 2-8°C promptly after use.  Unopened reagents can be used for 18 months from the date of manufacture, as indicated by the expiration date on the package and bottle labels.  Opened reagents can be used for one month if stored at 2-8°C.

PERFORMANCE
Precision
The within-run, between-run, and total precision for the K-ASSAY ®   High-Sensitive D-Dimer assay was determined using packaged reagents, human serum samples and controls, and a Roche / Hitachi 902 analyzer in accordance with CLSI EP5-A2.

  Sample 1 Sample 2 Sample 3 Sample 4 Sample 5
N 80 80 80 80 80
Mean (ng/mL) 178.7 923.4 2,632.0 5,456.3 6,616.4
Within Run S.D. 10.7 14.4 30.7 113.6 176.8
Within Run C.V. 6.0 % 1.6 % 1.2 % 2.1 % 2.7 %
Between Runs S.D. 10.2 18.6 39.5 92.1 77.2
Between Runs C.V. 5.7 % 2.0 % 1.5 % 1.7 % 1.2 %
Total S.D. 10.4 30.0 45.9 173.2 245.0
Total C.V. 5.8 % 3.2 % 1.7 % 3.2 % 3.7 %

Accuracy / Correlation
Testing was performed on a Roche / Hitachi 902 analyzer using unaltered, human citrated plasma samples and in accordance with the CLSI EP9-A2 guideline.  A comparison of the K-ASSAY ®   High-Sensitive D-Dimer and Company X's D-Dimer assay was performed with the following results:

Linear Regression: y = 0.6292x - 114.4416
r = 0.9944
n = 88
x = Company X's D-Dimer
y = K-ASSAY ®   High-Sensitive D-Dimer


Assay Range
30 - 8,000 ng/mL DDU
or
0.030 - 8.000 µg/mL DDU

INTERFERENCE
Testing was performed on a Roche / Hitachi 902 analyzer in accordance with the CLSI EP7-A2 guideline with the following results.
Criteria: Recovery within ± 10% of initial value

Bilirubin C:     No interference ≤ 200 mg/dL
Bilirubin F:     No interference ≤ 180 mg/dL
Chyle:     No interference ≤ 1,500 FTU
Hemoglobin :     No interference ≤ 500 mg/dL
Rheumatoid Factor :     No interference ≤ 500 IU/mL