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K-ASSAY
Since 1983
K-Assay
Clinical Diagnostics
Immunoassay Reagents
 
Plasma FDP
Cat. No.: KAI-111
Type.: Reagent
Method: Immunoturbidimetric
Format: Liquid
Linearity: 2 - 80 µg/mL (or value of highest calibrator)
Sample: Plasma


KIT COMPOSITION
Cat. No. KAI-111
R1:   2 X 10.5 mL buffer
R2:   1 X 6 mL antibody

Tests / Kit:   120 (Hitachi 917)
(Can Vary Based On Analyzer Model)
    
KAI-111
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 fibrin / fibrinogen degradation products in human plasma.
FOR RESEARCH USE ONLY IN THE U.S.
NOT FOR USE IN DIAGNOSTIC PROCEDURES 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 following within run precision results were abtained on a Roche/Hitachi analyzer with pooled human plasma:

  Sample 1 Sample 2
N 20 20
Mean 5.185 µg/mL 18.515 µg/mL
S.D. 0.1694 0.2159
C.V. 3.27 % 1.17 %

Accuracy / Correlation
A comparison of the K-ASSAY ®   Plasma FDP reagent and another company's Plasma FDP reagent was performed with the following results:

Linear Regression: y = 1.0025x - 0.7291
r = 0.9795
n = 52
x = another company's Plasma FDP assay
y = K-ASSAY ®   Plasma FDP Assay


Assay Range
2 - 80 µg/mL (or value of highest calibrator)

INTERFERENCE
Bilirubin C:     No interference ≤ 20 mg/dL
Bilirubin F:     No interference ≤ 18 mg/dL
Chyle (Formazine Turbidity)    No interference ≤ 2,400 FTU
Hemoglobin :     No interference ≤ 500 mg/dL
Rheumatoid Factor :     No interference ≤ 500 IU/mL