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K-ASSAY
Since 1983
K-Assay
 
Clinical Diagnostics
Immunoassay Reagents
 
D-Dimer
Cat. No.: KAI-090
Type.: Reagent
Method: Immunoturbidimetric
Format: Liquid (Lyophilized Calibrator)
Linearity: 0.5 - 30 µg/mL DDU   (or value of highest calibration point
Sample: Serum, Plasma


KIT COMPOSITION
R1:   1 X 16 mL buffer
R2:   1 X 8.5 mL antibody

Tests / Kit:   80 (Hitachi 717)
(Can Vary Based On Analyzer Model)
    
KAI-090
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
The K-ASSAY ®   D-Dimer Assay is an in vitro diagnostic reagent for the quantitative determination of cross-linked fibrin degradation products containing D-Dimer in human plasma or serum by immunoturbidimetric assay.
FOR IN VITRO DIAGNOSTIC USE.

REAGENT PREPARATION
The reagents are ready to use.  They do not need to be reconstituted.   Mix before using by genty inverting the bottles.  After openining, gently invert Reagent 2 once a week.

STORAGE AND HANDLING
All reagents should be stored refrigerated (2-8°C) and protected from light.  Return all reagents to 2-8°C promptly after use.  Unopened reagents can be used for one year 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

Precision - Within Run
Serum
Sample I Sample II Sample III
N = 5 N = 5 N = 5
Mean = 2.29 Mean = 9.60 Mean = 22.04
S.D. = 0.06 S.D. = 0.14 S.D. = 0.36
C.V. = 2.7% C.V. = 1.4% C.V. = 1.6%

Plasma
Sample I Sample II Sample III
N = 10 N = 10 N = 10
Mean = 3.55 Mean = 11.34 Mean = 21.12
S.D. = 0.09 S.D. = 0.12 S.D. = 0.12
C.V. = 2.5% C.V. = 1.1% C.V. = 0.6%


Precision - Between Runs
Serum
Sample I Sample II Sample III
N = 10 N = 10 N = 10
Mean = 2.44 Mean = 10.19 Mean = 28.43
S.D. = 0.06 S.D. = 0.19 S.D. = 0.27
C.V. = 2.5% C.V. = 1.9% C.V. = 0.95%

Plasma
Sample I Sample II Sample III
N = 5 N = 5 N = 5
Mean = 3.60 Mean = 11.56 Mean = 21.55
S.D. = 0.08 S.D. = 0.11 S.D. = 0.28
C.V. = 2.27% C.V. = 0.96% C.V. = 1.30%

Accuracy / Correlation
A comparison of the K-ASSAY ®   D-Dimer reagent (KAI-090) and the K-ASSAY ®   D-Dimer reagent (KAI-078) was performed with the following results:

y = 0.964x - 0.1742
r = 0.9801
n = 80
x = K-ASSAY ®   D-Dimer (KAI-078)
y = K-ASSAY ®   D-Dimer (KAI-090)

Assay Range
0.5 - 30 µg/mL DDU   (or value of highest calibration point)

INTERFERENCE
Bilirubin F :     No interference up to 18 mg/dL
Bilirubin C :     No interference up to 21.2 mg/dL
Hemoglobin :     No interference up to 500 mg/dL
RF :     No interference up to 520 IU/mL
Citric Acid (sodium) :     No interference up to 500 mg/dL
Ascorbic Acid :     No interference up to 100 mg/dL
NaF :     No interference up to 400 mg/dL
Heparin :     No interference up to 400 mg/dL
EDTA-2Na :     No interference up to 100 mg/dL
Chyle (Formazine Turbidity) :     No interference up to 3,000
Fibrinogen :     No interference up to 500 mg/dL