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K-ASSAY
Since 1983
K-Assay
 
Clinical Diagnostics
Immunoassay Reagents
 
CRP (3)
C-Reactive Protein (3)
Wide Range CRP
Cat. No.: KAI-082
Type.: Reagent
Method: Immunoturbidimetric
Format: Liquid
Linearity: With CRP (3) Calibrator Set E (Cat. No. KAI-084C) :
0.05 - 160 mg/L
or
0.005 - 16.0 mg/dL

With CRP (3) Calibrator Set F (Cat. No. KAI-086C) :
0.2 - 480 mg/L
or
0.02 - 48.0 mg/dL
Sample: Serum, Plasma


KIT COMPOSITION
R1:   1 X 50 mL buffer
R2:   1 X 50 mL antibody

Tests / Kit:   333 (Hitachi 717)
(Can Vary Based On Analyzer Model And Calibrator Set Used)
    
KAI-082
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
K-ASSAY ®   CRP (3) is intended to be used as a high-sensitive assay for the quantitative determination of CRP in serum and plasma by immunoturbidimetric assay.   Measurement of C-Reactive Protein aids in the detection and evaluation of tissue injury, inflammatory disorders, and related diseases.
FOR IN VITRO DIAGNOSTIC USE.

REAGENT PREPARATION
The reagents are ready to use and do not require reconstitution.  Mix gently before using.

STORAGE AND HANDLING
All reagents should be stored at 2-8°C and protected from light.  Unopened reagents can be used for 18 months from the date of manufacture as indicated on the expiration date on the package and bottle labels. Once the reagent vial has been opened, store tightly capped at 2-8°C and use within 1 month.

PERFORMANCE
Precision
The following data was obtained using a Hitachi 917 analyzer and standard protocol.   Samples tested were commercial human CRP control serum.

Precision - Within Run   - Using CRP (3) Calibrator Set D
Sample I Sample II Sample III
N = 20 N = 20 N = 20
Mean = 0.48 mg/L
          or
Mean = 0.048 mg/dL
Mean = 2.42 mg/L
          or
Mean = 0.242 mg/dL
Mean = 9.80 mg/L
          or
Mean = 0.980 mg/dL
S.D. = 0.02 S.D. = 0.04 S.D. = 0.09
C.V. = 4.3% C.V. = 1.6% C.V. = 0.87%

Precision - Between Runs   - Using CRP (3) Calibrator Set D
Sample I Sample II Sample III
N = 21 N = 21 N = 21
Mean = 0.5 mg/L
          or
Mean = 0.05 mg/dL
Mean = 2.2 mg/L
          or
Mean = 0.22 mg/dL
Mean = 9.8 mg/L
          or
Mean = 0.98 mg/dL
S.D. = 0.03 S.D. = 0.07 S.D. = 0.12
C.V. = 6.97% C.V. = 3.35% C.V. = 1.23%

Accuracy / Correlation

y = 1.012x + 0.0051
r = 0.999
x = Company A's latex hsCRP nephelometric assay
y = K-ASSAY ®   CRP (3)

Assay Range

With CRP (3) Calibrator Set D (Cat. No. KAI-083C) :
     0.1 - 320 mg/L
              or
     0.01 - 32.00 mg/dL

With CRP (3) Calibrator Set E (Cat. No. KAI-084C) :
     0.05 - 160 mg/L
              or
     0.005 - 16.0 mg/dL

With CRP (3) Calibrator Set F (Cat. No. KAI-086C) :
     0.2 - 480 mg/L
              or
     0.02 - 48.00 mg/dL

INTERFERENCE
Bilirubin F and C :     No interference up to 30 mg/dL
Hemoglobin :     No interference up to 500 mg/dL
Lipid :     No interference up to 5% Intrafat
Rheumatoid Factor :     No interference up to 560 IU/mL