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K-ASSAY
Since 1983
K-Assay
 
Clinical Diagnostics
Immunoassay Controls
 
ASO / RF / CRP Control
Cat. No.: K55C-2M or K55C-4M
Type.: Control


KIT COMPOSITION
Cat. No. K55C-2M
Level 1 Human Serum 1 x 2 mL, lyophilized
Level 2 Human Serum 1 x 2 mL, lyophilized
    
K55C-2M
Click Image To Enlarge       

Click here for an example package insert.

Click here for the Safety Data Sheet (SDS).




Cat. No. K55C-4M
Level 1 Human Serum 2 x 2 mL, lyophilized
Level 2 Human Serum 2 x 2 mL, lyophilized
    
K55C-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 ®   ASO/RF/CRP Control is intended to be used as a consistent test sample of known concentrations for monitoring the K-ASSAY ®
Anti-Streptolysin O (ASO),
Rheumatoid Factor (RF),
C-Reactive Protein (CRP),
and wide range CRP
immunoturbidimetric assays.
FOR IN VITRO DIAGNOSTIC USE.

CONTROL PREPARATION
 1.  Carefully and slowly remove rubber stopper and let air enter vacuum-sealed bottle.

 2.  Carefully add exactly 2 mL purified water (at room temperature) to bottle.   DO NOT MIX.

 3.  Replace rubber stopper.

 4.  Let bottle sit at room temperature for 10 minutes.

 5.  Mix by slowly swirling bottle numerous times.  DO NOT SHAKE or induce foaming.

 6.  Continue to mix until all contents have dissolved completely.

 7.  Before each subsequent use, be sure to mix bottle by slowly swirling.

STORAGE AND HANDLING
Store lyophilized and reconstituted controls at 2-8°C.  Return all controls to 2-8°C 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.

Reconstituted controls can be used for 2 weeks if stored at 2-8°C.

Reconstituted controls can also be frozen immediately after reconstitution at -20°C for 2 months and then thawed ONE TIME ONLY.

EXPECTED VALUES
The following values are given as an example.  The expected values for the K-ASSAY ®   ASO/RF/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   LEVEL 1   LEVEL 2 
 MEAN   RANGE   MEAN   RANGE 
  ASO     258 IU/mL     232 - 284 IU/mL     427 IU/mL     384 - 470 IU/mL  
  RF     32 IU/mL     22 - 42 IU/mL     82 IU/mL     66 - 98 IU/mL  
  CRP     1.1 mg/dL     0.8 - 1.4 mg/dL     3.8 mg/dL     3.3 - 4.3 mg/dL  
  CRP(3) Cal D     13.62 mg/L     10.89 - 16.34 mg/L     41.20 mg/L     32.96 - 49.44 mg/L  
  CRP(3) Cal E     11.12 mg/L     8.89 - 13.34 mg/L     37.41 mg/L     29.93 - 44.89 mg/L  
  CRP(3) Cal F     11.5 mg/L     9.2 - 13.8 mg/L     37.1 mg/L     29.7 - 44.6 mg/L  

ASO: Standardized against the WHO NIBSC Anti-Streptolysin-O standard material.

RF: Standardized against the WHO International Reference Preparation of Rheumatoid Arthritis Serum.

CRP, CRP(3): Standardized against CAP/BCR/IFCC Reference Preparation for Proteins in Human Serum (RPPHS), lot 91/0619.