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Cat. No. KAI-090

D-Dimer

For In-Vitro Diagnostic Use
KIT COMPOSITION

Reagent 1 (R-1) 16 ml Buffer Reagent
Reagent 2 (R-2) 8.5 ml Antibody Reagent


PERFORMANCE

Precision

Precision Assay: Within Run
Sample I Sample II Sample III
N=5
Mean=2.29
SD=0.06
CV=2.7%
N=5
Mean=9.60
SD=0.14
CV=1.4%
N=5
Mean=22.04
SD=0.36
CV=1.6%

Precision Assay: Between Run
Sample I Sample II Sample III
N=10
Mean=2.44
SD=0.06
CV=2.5%
N=10
Mean=10.19
SD=0.19
CV=1.9%
N=10
Mean=28.43
SD=0.27
CV=0.95%

Assay Range

0.5-30 mg/ml (for quantitative measurement)

Correlation

80 patient plasma samples were assayed using the D-Dimer on a Hitachi 717 and D-Dimer (KAI-078).  The following results were obtained:

 

Y
 r
 X 
 Y 
=  0.964X - 0.1742
=  0.9801
D-Dimer (KAI-078)
D-Dimer
 

INTERFERENCE

Bilirubin F
Hemoglobin
RF
Heparin
Citric Acid (Na)
EDTA-2Na
Chylus
NaF
No interference up to 18 mg/dl
No interference up to 500 mg/dl
No interference up to 520 IU/ml
No interference up to 400 mg/dl
No interference up to 500 mg/dl
No interference up to 100 mg/dl
No interference up to 3,000 mg/dl
No interference up to 500 mg/dl
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