K Logo Kamiya Biomedical Company
K-ASSAY
Since 1983
K-Assay
 
Clinical Diagnostics
Immunoassay Reagents
 
Complement C3
Cat. No.: KAI-009
Type.: Reagent
Method: Immunoturbidimetric
Format: Liquid
Linearity: 30 - 350 mg/dL
Sample: Serum


KIT COMPOSITION
R1:   4 X 20 mL buffer
R2:   2 X 10 mL antibody

Tests / Kit:   285 (Hitachi 717)
(Can Vary Based On Analyzer Model)
    
KAI-009
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 human complement C3 (3rd complement component) in serum by immunoturbidimetric assay.  Complement is a group of serum proteins that destroy infectious agents.  Measurement of these proteins aids in the diagnosis of immunological disorders, especially those associated with deficiencies of complement components.
FOR IN VITRO DIAGNOSTIC USE.

REAGENT PREPARATION
The reagents are ready to use.  They do not need to be reconstituted.

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 ®   Complement C3 assay was determined using packaged reagents, pooled human serum, and a Hitachi 717 analyzer.

Precision - Within Run
Sample I Sample II Sample III
N = 20 N = 20 N = 20
Mean = 33.7 Mean = 75.6 Mean = 112.4
S.D. = 1.12 S.D. = 1.68 S.D. = 2.18
C.V. = 3.33% C.V. = 2.22% C.V. = 1.94%

Precision - Between Runs
Sample I Sample II Sample III
N = 10 N = 10 N = 10
Mean = 35.4 Mean = 84.3 Mean = 114.4
S.D. = 1.29 S.D. = 1.95 S.D. = 1.70
C.V. = 3.63% C.V. = 2.31% C.V. = 1.48%

Accuracy / Correlation
A comparison of the K-ASSAY ®   Complement C3 assay and an INCSTAR Complement C3 Test Kit was performed using a Hitachi 717.  The test results provided the following data:

y = 0.842x + 4.727
r = 0.925
n = 60
x = INCSTAR Complement C3 Test Kit
y = K-ASSAY ®   Complement C3 assay

x min = 78 y min = 74
  max = 188   max = 171
  mean = 135   mean = 118

Assay Range
30 - 350 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%