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K-ASSAY
Since 1983
K-Assay
 
Clinical Diagnostics
Immunoassay Reagents
 
Cystatin C
Cat. No.: KAI-073   or   KAI-074
Type.: Reagent
Method: Immunoturbidimetric
Format: Liquid
Linearity: 0.06 - 8.00 mg/L   (0.05 - 6.80 mg/L*)
(* ERM-DA471/IFCC Standardized)
Measuring Range: 0.40 - 8.00 mg/L   (0.34 - 6.80 mg/L*)
(* ERM-DA471/IFCC Standardized)
Sample: Serum, EDTA Plasma, Lithium Heparin Plasma


KIT COMPOSITION
Cat. No. KAI-073
R1:   1 X 10 mL buffer
R2:   1 X 10 mL antibody

Tests / Kit:   100 (Hitachi 917)
(Can Vary Based On Analyzer Model)
    
KAI-073
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-074
R1:   2 X 10 mL buffer
R2:   2 X 10 mL antibody

Tests / Kit:   200 (Hitachi 917)
(Can Vary Based On Analyzer Model)

    
KAI-074
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 cystatin C in serum, EDTA plasma, or lithium heparin plasma by immunoturbidimetric assay.  Cystatin C measurements are used as an aid in the diagnosis and treatment of renal diseases.
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 ®   Cystatin C assay was determined using packaged reagents, control material, and a Roche / Hitachi 917 analyzer according to the CLSI EP5-A2 guideline.

  Sample
1
Sample
2
Sample
3
Sample
4
N 80 80 80 80
Mean (mg/L) 0.511 0.968 1.999 4.389
Within Run S.D. 0.006 0.007 0.013 0.030
Within Run C.V. % 1.094 0.712 0.640 0.690
Between Run S.D. 0.005 0.024 0.019 0.079
Between Run C.V. % 1.066 2.496 0.960 1.811
Between Day S.D. 0.005 0.017 0.014 0.023
Between Day C.V. % 0.928 1.776 0.707 0.525
Total S.D. 0.007 0.024 0.027 0.088
Total C.V. % 1.421 2.462 1.353 2.008

Accuracy / Correlation
Testing was performed on a Roche / Hitachi 917 analyzer according to the CLSI EP9-A2 guideline.  A comparison of the K-ASSAY ®   Cystatin C and another company's Cystatin C assay was performed with the following results:

Linear Regression: y = 1.0093x - 0.0411
r = 0.9983
n = 50
x = another company's cystatin C assay
y = K-ASSAY ®   Cystatin C assay

x min = 0.41 mg/L y min = 0.40 mg/L
  max = 7.43 mg/L   max = 7.68 mg/L
  mean = 2.650 mg/L   mean = 2.633 mg/L

Linearity
0.06 - 8.00 mg/L   (0.05 - 6.80 mg/L*)
(* ERM-DA471/IFCC Standardized)

Measuring Range
0.40 - 8.00 mg/L   (0.34 - 6.80 mg/L*)
(* ERM-DA471/IFCC Standardized)

INTERFERENCE
Testing was performed on a Roche / Hitachi 917 analyzer according to the CLSI EP7-A2 guideline with the following results.

Bilirubin, Conjugated :     No interference up to 60 mg/dL
Bilirubin, Unconjugated :     No interference up to 60 mg/dL
Hemoglobin :     No interference up to 900 mg/dL
Intralipid :     No interference up to 11 g/L
Rheumatoid Factor :     No interference up to 1,000 IU/L
Triglycerides :     No interference up to 1,500 mg/dL