K Logo Kamiya Biomedical Company
K-ASSAY
Since 1983
K-Assay
 
Clinical Diagnostics
Immunoassay Reagents
 
CRP
C-Reactive Protein
Cat. No.: KAI-026   or   KAI-033
Type.: Reagent
Method: Immunoturbidimetric
Format: Liquid
Linearity: 1 - 250 mg/L
or
0.1 - 25.0 mg/dL
Sample: Serum


KIT COMPOSITION
Cat. No. KAI-026
R1:   4 X 20 mL buffer
R2:   2 X 10 mL antibody

Tests / Kit:   285 (Hitachi 717)
(Can Vary Based On Analyzer Model)
    
KAI-026
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.




Cat. No. KAI-033
Note: Large size kit, available by special order.
R1:   3 X 80 mL buffer
R2:   1 X 60 mL antibody

Tests / Kit:   855 (Hitachi 717)
(Can Vary Based On Analyzer Model)

    
KAI-033
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
For the quantitative determination of C-reactive protein (CRP) in serum by immunoturbidimetric assay.  Measurement of CRP aids in the evaluation of the amount of injury to body tissues.
FOR IN VITRO DIAGNOSTIC USE.

REAGENT PREPARATION
The reagents are ready to use and do not require reconstitution.

STORAGE AND HANDLING
All reagents should be stored refrigerated (2-8°C).  Return all reagents to 2-8°C promptly after use.  Unopened reagents can be used for one year from the date of manufacture, as indicated by the expiration date on the package and bottle labels.  Opened reagents can be used for one month if stored at 2-8°C.

PERFORMANCE
Precision
The precision for the K-ASSAY ®   CRP assay was determined using packaged reagents, normal human serum spiked with known concentrations of human CRP, and a Hitachi 704 analyzer.

Precision - Within Run
Sample I Sample II Sample III
N = 20 N = 20 N = 20
Mean = 0.646 Mean = 3.147 Mean = 10.354
S.D. = 0.0278 S.D. = 0.0399 S.D. = 0.1052
C.V. = 4.30% C.V. = 1.27% C.V. = 1.02%

Precision - Between Runs
Sample I Sample II Sample III
N = 6 N = 6 N = 6
Mean = 1.97 Mean = 5.33 Mean = 11.08
S.D. = 0.10 S.D. = 0.10 S.D. = 0.2
C.V. = 5.25% C.V. = 1.94% C.V. = 0.68%

Accuracy / Correlation
A comparison of the K-ASSAY ®   CRP assay and another company's CRP Test Kit was performed using a Hitachi 704.  The test results provided the following data:

y = 0.9737x + 0.0003
r = 0.99838
x = another company's CRP assay
y = K-ASSAY ®   CRP assay

Assay Range
1 - 250 mg/L
         or
0.1 - 25.0 mg/dL

INTERFERENCE
Bilirubin F and C :     No interference up to 20 mg/dL
Hemoglobin :     No interference up to 500 mg/dL
Lipemia :     No interference up to 5%