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K-ASSAY
Since 1983
K-Assay
Clinical Diagnostics
Immunoassay Reagents
 
Serum/Urine FDP
Cat. No.: KAI-107
Type.: Reagent
Method: Immunoturbidimetric
Format: Liquid
Linearity: Serum : 0.2 - 80 µg/mL (or value of highest calibrator)

Urine : 0.02 - 3.2 µg/mL (or value of highest calibrator)
Sample: Serum,Urine


KIT COMPOSITION
Cat. No. KAI-107
R1:   2 X 12 mL buffer
R2:   1 X 5 mL antibody

Tests / Kit (Hitachi 917):
Serum: 125
Urine: 138
(Can Vary Based On Analyzer Model)
    
KAI-107
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 serum and urine.
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 serum or urine:

  Serum
Sample 1 Sample 2
N 20 20
Mean 3.97 µg/mL 14.42 µg/mL
S.D. 0.0979 0.1725
C.V. 2.47 % 1.20 %

  Urine
Sample 1 Sample 2
N 10 10
Mean 0.359 µg/mL 0.963 µg/mL
S.D. 0.0137 0.0095
C.V. 3.82 % 0.99 %


Accuracy / Correlation

Serum
A comparison of the K-ASSAY ®   Serum/Urine FDP reagent and another company's FDP reagent was performed with the following results on serum samples:

Linear Regression: y = 0.9697x + 0.2924
r = 0.9990
n = 62
x = another company's Serum FDP assay
y = K-ASSAY ®   Serum/Urine FDP Assay


Urine
A comparison of the K-ASSAY ®   Serum/Urine FDP reagent and another company's Urine FDP reagent was performed with the following results on urine samples:

Linear Regression: y = 0.9503x + 0.0448
r = 0.9866
n = 36
x = another company's Urine FDP assay
y = K-ASSAY ®   Serum/Urine FDP Assay


Assay Range
Serum : 0.2 - 80 µg/mL (or value of highest calibrator)

Urine : 0.02 - 3.2 µg/mL (or value of highest calibrator)

INTERFERENCE
Serum and Urine
Bilirubin C:     No interference ≤ 20 mg/dL
Bilirubin F:     No interference ≤ 20 mg/dL
Hemoglobin :     No interference ≤ 500 mg/dL
 
Serum
Chyle (Formazine Turbidity)    No interference ≤ 3,000 FTU
Rheumatoid Factor:     No interference ≤ 570 IU/mL