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K-ASSAY
Since 1983
K-Assay
 
Clinical Diagnostics
Immunoassay Controls
 
Liquid ITA Control
Cat. No.: K49C-2M or K49C-4M
Type.: Control


KIT COMPOSITION
Cat. No. K49C-2M
Level 1 Human Serum 1 x 2 mL, liquid
Level 2 Human Serum 1 x 2 mL, liquid
    
K49C-2M
Click Image To Enlarge       

Click here for an example package insert.

Click here for the Safety Data Sheet (SDS).




Cat. No. K49C-4M
Level 1 Human Serum 2 x 2 mL, liquid
Level 2 Human Serum 2 x 2 mL, liquid
    
K49C-4M
Click Image To Enlarge       

Click here for an example package insert.

Click here for the Safety Data Sheet (SDS).


INTENDED USE
The K-ASSAY ®   Liquid ITA Control is intended to be used as a consistent test sample of known concentration for monitoring the performance of K-ASSAY ®   immunoturbidimetric assays (ITA) for the listed constituents.
Alpha-1 Acid Glycoprotein (Cat. No. KAI-021)
Alpha-1 Anti-Trypsin (Cat. No. KAI-001)
C-Reative Protein (Cat. No. KAI-026)
Complement C3 (Cat. No. KAI-009)
Complement C4 (Cat. No. KAI-010)
Haptoglobin (Cat. No. KAI-022)
IgA (Cat. No. KAI-013)
IgG (Cat. No. KAI-014)
IgM (Cat. No. KAI-015)
Prealbumin (Cat. No. KAI-053)
Transferrin (Cat. No. KAI-023)
FOR IN VITRO DIAGNOSTIC USE.

CONTROL PREPARATION
Controls are liquid and ready to use.

STORAGE AND HANDLING
Store controls at 2-8°C.  Return all controls to 2-8° promptly after use.   Unopened controls can be used for one year from the date of manufacturing as indicated by the expiration date on the package and bottle labels.

Opened controls can be used for 1 month if stored at 2-8°C.

EXPECTED VALUES
The following values are given as an example.  The expected values for the K-ASSAY ®   Liquid ITA 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   LEVEL 1   LEVEL 2 
 MEAN 
 (mg/dL) 
 RANGE 
 (mg/dL) 
 MEAN 
 (mg/dL) 
 RANGE 
 (mg/dL) 
  Alpha-1 Acid Glycoprotein     69     55 - 83     130     117 - 143  
  Alpha-1 Anti-Trypsin     115     92 - 138     224     202 - 246  
  C-Reactive Protein     1.1     0.8 - 1.4     3.8     3.3 - 4.3  
  Complement C3     98     78 - 118     243     219 - 267  
  Complement C4     19     15 - 23     45     40 - 50  
  Haptoglobin     96     77 - 115     203     183 - 223  
  IgA     176     141 - 211     427     384 - 470  
  IgG     855     684 - 1,026     2,149     1,934 - 2,364  
  IgM     77     62 - 92     185     166 - 204  
  Prealbumin     20     16 - 24     41     37 - 45  
  Transferrin     238     190 - 286     455     409 - 501  

Note: Values are standardized to the CAP/BCR/IFCC Reference Preparation for Proteins in Human Serum (RPPHS), lot 91/0619.