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K-ASSAY
Since 1983
K-Assay
 
Clinical Diagnostics
Immunoassay Reagents
 
Fibrinogen
Cat. No.: KAI-035   or   KAI-135   or   KAI-088
Type.: Reagent
Method: Immunoturbidimetric
Format: Liquid (Lyophilized Calibrator)
Linearity: 100 - 900 mg/dL
or
81 - 729 mg/dL (using NIBSC international standard)
Sample: Plasma


KIT COMPOSITION
Cat. No. KAI-035
R1:   2 X 20 mL buffer
R2:   1 X 8 mL antibody
Calibrator: 1 x 1 mL (lyophilized)

Tests / Kit:   160 (Hitachi 717)
(Can Vary Based On Analyzer Model)
    
KAI-035
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)
Calibrator

Click here for information about recommended controls.




Cat. No. KAI-135
R1:   2 X 20 mL buffer
R2:   1 X 8 mL antibody

Tests / Kit:   160 (Hitachi 717)
(Can Vary Based On Analyzer Model)
    
KAI-135
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.




Cat. No. KAI-088
Note: Large size kit, available by special order.
R1:   4 X 50 mL buffer
R2:   1 X 40 mL antibody
(No calibrator)

Tests / Kit:   800 (Hitachi 717)
(Can Vary Based On Analyzer Model)

    
KAI-088
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 fibrinogen levels in disseminated intravascular coagulation (non-localized clotting within the blood vessels) and primary fibrinolysis (the dissolution of fibrinogen in a blood clot.
FOR IN VITRO DIAGNOSTIC USE.

REAGENT PREPARATION
R1 and R2 are ready to use and do not require reconstitution.
The calibrator is lyophilized and requires reconstition and preparation of dilutions according the the package insert instructions.

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 one year from the date of manufacture, as indicated by the expiration date on the package and bottle labels.  Opened R1 and R2 can be used for one month if stored at 2-8°C.  Reconstituted fibrinogen calibrator and the diluted calibrator solutions can be used for 1 week if stored at 2-8°C.

PERFORMANCE
Precision

Precision - Within Run
Sample I Sample II Sample III
N = 20 N = 20 N = 20
Mean = 142.4 Mean = 444.7 Mean = 739.6
Min = 136 Min = 429 Min = 721
Max = 152 Max = 456 Max = 763
C.V. = 2.96% C.V. = 1.48% C.V. = 1.43%

Precision - Between Runs
Sample I Sample II Sample III
N = 10 N = 10 N = 10
Mean = 167.4 Mean = 323.6 Mean = 554.1
Min = 165 Min = 316 Min = 544
Max = 170 Max = 329 Max = 571
C.V. = 0.94% C.V. = 1.06% C.V. = 1.50%

Accuracy / Correlation
A comparison of the K-ASSAY ®   Fibrinogen test and an Incstar Fibrinogen Test Kit was performed using a Hitachi 717.  The test results provided the following data:

y = 0.967x + 33.91
r = 0.995
n = 50
x = Incstar Fibrinogen Test Kit
y = K-ASSAY ®   Fibrinogen

Additional correlation studies on assays using the Clauss method (clotting method) are available.

Assay Range
100 - 900 mg/dL
        or
81 - 729 (using NIBSC international standard)

INTERFERENCE
Bilirubin C :     No interference up to 25 mg/dL
Hemoglobin :     No interference up to 500 mg/dL