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K-ASSAY
Since 1983
K-Assay
 
Clinical Diagnostics
Immunoassay Controls
 
High-Sensitive CRP Control
Cat. No.: K80C-4M
Type.: Control


KIT COMPOSITION
Level 1 Human Serum 2 x 1 mL, liquid
Level 2 Human Serum 2 x 1 mL, liquid
    
K80C-4M
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Click here for an example package insert.

Click here for the Safety Data Sheet (SDS).


INTENDED USE
The K-ASSAY ®   High-Sensitive CRP Control is intended for use as an assayed quality control material for monitoring the performance of C-Reactive Protein (CRP) immunoturbidimetric assays such as hsCRP and wide range CRP.
FOR IN VITRO DIAGNOSTIC USE.

CONTROL PREPARATION
 1.  Gently invert the bottle before use.

 2.  The control is ready to use.

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

STORAGE AND HANDLING
Store controls at 2-8°C.  Return all controls to 2-8°C promptly after use.   Controls can be used up to the expiration date shown on the vial label and package insert.

EXPECTED VALUES
The following values are given as an example.  The expected values for the K-ASSAY ®   High-Sensitive CRP 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   ANALYZER   LEVEL 1   LEVEL 2 
 MEAN 
 (mg/L) 
 RANGE 
 (mg/L) 
 MEAN 
 (mg/L) 
 RANGE 
 (mg/L) 
 K-ASSAY ®   CRP (2) + Cal B   Hitachi 911   0.47   0.37 - 0.56   1.62   1.30 - 1.95 
 Beckman CX7   0.55   0.44 - 0.66   1.62   1.30 - 1.95 
 K-ASSAY ®   CRP (3) + Cal D   Hitachi 911   0.69   0.55 - 0.83   2.42   1.94 - 2.91 
 K-ASSAY ®   CRP (3) + Cal E   Hitachi 911   0.54   0.43 - 0.64   1.72   1.38 - 2.07 
 K-ASSAY ®   CRP (3) + Cal F   Hitachi 911   0.6   0.5 - 0.7   1.9   1.5 - 2.3 

Note: The above are standardized to the International Federation of Clinical Chemistry (IFCC) International Reference Preparation for Plasma Protein CRM 470.


Controls assayed with reagents from various manufacturers:
 ANALYTE   ANALYZER   LEVEL 1   LEVEL 2 
 MEAN 
 (mg/L) 
 RANGE 
 (mg/L) 
 MEAN 
 (mg/L) 
 RANGE 
 (mg/L) 
 NhsCRP   Dade Behring BNII   0.44   0.35 - 0.53   1.40   1.12 - 1.68 
 CRPH   Beckman Coulter Immage   0.53   0.42 - 0.64   2.11   1.69 - 2.53 
 CRP   Olympus AU 400 / 640   0.53   0.42 - 0.64   1.65   1.32 - 1.98