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K-ASSAY
Since 1983
K-Assay
 
Clinical Diagnostics
Immunoassay Reagents
 
hsCRP
High-Sensitive C-Reactive Protein
High-Sensitive CRP
Cat. No.: KAI-160
Type.: Reagent
Method: Immunoturbidimetric
Format: Liquid
Linearity: 0.20 - 20.0 mg/L
or
0.020 - 2.00 mg/dL
Sample: Serum, Plasma


KIT COMPOSITION
R1:   1 X 50 mL buffer
R2:   1 X 10 mL antibody

Tests / Kit:   200 (Hitachi 917)
(Can Vary Based On Analyzer Model)
    
KAI-160
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 in vitro quantitative determination of C-reactive protein (CRP) in human serum and plasma on automated clinical chemistry analyzers.  Measurement of CRP is of use for the detection and evaluation of inflammatory disorders and associated diseases, infection and tissue injury.
For in vitro diagnostic use only.

REAGENT PREPARATION
1. The K-ASSAY ®   hsCRP reagents are provided ready-to-use.
2. Physiological saline is needed to dilute high CRP samples and is used as a zero calibrator.

STORAGE AND HANDLING
The K-ASSAY ®   hsCRP assay reagents should be stored at 2-8°C.  DO NOT FREEZE.  The reagents are stable when stored as instructed until the expiration date of the label.   Do not mix reagent components from different lots.

PERFORMANCE
Precision
The intra-precision of the K-ASSAY ®   hsCRP Assay was evaluated as follows: in the study, three serum controls containing CRP were tested in duplicates on a Hitachi 917 over 20 days with 2 runs per day.

  Level 1
1
Level 2
2
Level 3
3
Serum
4
Serum
4
N 80 80 80 80 20*
Mean (mg/L) 0.85 1.75 8.62 3.62 15.56
Within Run S.D. 0.03 0.03 0.06 0.05 0.19
Within Run C.V. % 4.0 1.7 0.7 1.4 1.2
Total S.D. 0.04 0.05 0.12 0.09 0.24
Total C.V. % 4.2 2.6 1.4 2.4 1.6
*Sample was tested on Hitachi 917 over 5 days with 2 runs per day

Accuracy / Correlation

y = 1.01x + 0.0196
r = 0.995
x = Company A's CRP assay
y = K-ASSAY ®   hsCRP

Assay Range

     0.2 - 20 mg/L
              or
     0.02 - 2.0 mg/dL

INTERFERENCE
The following substances do not interfere with this assay at the levels tested
(less than 10% basis):

Ascorbic Acid :     No interference up to 176 mg/dL
Bilirubin, Conjugated :     No interference up to 40 mg/dL
Bilirubin, Unconjugated :     No interference up to 40 mg/dL
Hemoglobin :     No interference up to 500 mg/dL
Rheumatoid Factor :     No interference up to 400 IU/L
Triglycerides :     No interference up to 1,000 mg/dL