K Logo Kamiya Biomedical Company
K-ASSAY
Since 1983
K-Assay
Clinical Diagnostics
Immunoassay Reagents
 
Factor XIII
Cat. No.: KAI-105
Type.: Reagent
Method: Immunoturbidimetric
Format: Liquid
Linearity: 2.3 % - 140 % (or value of highest calibrator)
Sample: Plasma


KIT COMPOSITION
Cat. No. KAI-105
R1:   2 X 9.5 mL buffer
R2:   1 X 6 mL antibody

Tests / Kit:   120 (Hitachi 917)
(Can Vary Based On Analyzer Model)
    
KAI-105
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 Coagulation Factor XIII in human plasma.
FOR IN VITRO DIAGNOSTIC USE.

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 Sample 3
N 10 10 10
Mean 96.72 % 54.77 % 36.50 %
S.D. 0.6408 0.5945 0.2108
C.V. 0.66 % 1.09 % 0.58 %

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

Linear Regression: y = 0.9692x - 2.039
r = 0.9946
n = 50
x = another company's latex Factor XIII
y = K-ASSAY ®   Factor III


Assay Range
2.3 % - 140 % (or value of highest calibrator)

INTERFERENCE
Bilirubin C:     No interference ≤ 22.0 mg/dL
Bilirubin F:     No interference ≤ 19.7 mg/dL
Chyle (Formazine Turbidity)    No interference ≤ 2,400 FTU
Hemoglobin :     No interference ≤ 450 mg/dL
Rheumatoid Factor :     No interference ≤ 570 IU/mL