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K-ASSAY
Since 1983
K-Assay
 
Clinical Diagnostics
Immunoassay Controls
 
Plasma Control
Cat. No.: K81C-6M
Type.: Control


KIT COMPOSITION
Level 1 Human Plasma 3 x 0.5 mL, lyophilized
Level 2 Human Plasma 3 x 0.5 mL, lyophilized
    
K81C-6M
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Click here for an example package insert.

Click here for the Safety Data Sheet (SDS).


INTENDED USE
The K-ASSAY ®   Plasma Control is intended to be used as a consistent test sample of known concentration for monitoring the performance of D-Dimer and Plasminogen assays.
FOR IN VITRO DIAGNOSTIC USE.

Values for AT-III, α2PI, and FDP are for research use only in the U.S.  Not for use in diagnostic procedures in the U.S.

CONTROL PREPARATION
 1.  Reconstitute Plasma Control with 0.5 mL of distilled water.

 2.  Gently invert vial until dissolution is complete (do not shake).

 3.  Allow the vial to sit at room temperature (18-26°C) for 25 minutes prior to use.

 4.  Replace the cap immediately after use to prevent evaporation or contamination.

 5.  Return the vial to 2-8°C promptly after use.
STORAGE AND HANDLING
Store controls at 2-8°C.  Return all controls to 2-8° promptly after use.   Reconstituted controls can be used up to a week if kept at 2-8°C and a month at -20°C (with 1 time thawing only).

EXPECTED VALUES
The following values are given as an example.  The expected values for the K-ASSAY ®   Plasma Control are continually being revised through ongoing quality assurance.   As a result, the expected values may change from lot to lot.  Please refer to the package insert and/or vial labels for each lot for the expected values.

 ANALYTE   UNIT   LEVEL 1   LEVEL 2 
 MEAN   RANGE   MEAN   RANGE 
 K-ASSAY ®  D-Dimer (KAI-090)   µg/mL   1.11   0.89 - 1.33   12.66   10.12 - 15.19 
 AT-III (Antigen)*   mg/dL   28.5   23.4 - 33.6   14.6   12.4 - 16.8 
 α2PI (Activity) *   %   89.5   72.4 - 106.6   46.4   34.7 - 58.1 
 FDP (Antigen) *   µg/mL   6.5   5.4 - 7.6   30.8   24.7 - 36.9 
 Plasminogen (Activity)   %   90.3   79.8 - 100.8   50.2   40.2 - 60.2 

* For research use only in the U.S.   Not for diagnostic procedures in the U.S.